Chapter 1 General Provisions

Article 1 These Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices in order to standardize the registration and filing of in vitro diagnostic reagents and ensure the safety, effectiveness and controllable quality of in vitro diagnostic reagents.

Article 2 These Measures shall apply to the registration, filing, and supervision and management of in vitro diagnostic reagents within the territory of the People's Republic of China.

Article 3 The in vitro diagnostic reagents referred to in these Measures refer to in vitro diagnostic reagents managed according to medical devices, including reagents, kits, calibrators, quality controls and other products used for in vitro testing of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation, which can be used alone or in combination with instruments, appliances, equipment or systems.

In vitro diagnostic reagents used for blood source screening and in vitro diagnostic reagents labeled with radionuclides are not within the scope of these Measures.

Article 4 In vitro diagnostic reagent registration refers to the activity in which the applicant for in vitro diagnostic reagent registration (hereinafter referred to as the applicant) submits an application for registration of in vitro diagnostic reagents in accordance with legal procedures and requirements, and the drug administration department conducts a review of safety, efficacy and quality controllability in accordance with laws and regulations and scientific cognition, and decides whether to agree to the application.

In vitro diagnostic reagent filing refers to the activity in which the in vitro diagnostic reagent filer (hereinafter referred to as the filer) submits filing materials to the drug administration department in accordance with legal procedures and requirements, and the drug administration department files the submitted filing materials for future reference.

Article 5 The State Medical Products Administration is responsible for the registration and filing management of in vitro diagnostic reagents nationwide, and is responsible for establishing a system for the registration and filing management of in vitro diagnostic reagents, organizing the review and approval of domestic Class III and imported Class II and III in vitro diagnostic reagents in accordance with the law, and the filing of imported Class I in vitro diagnostic reagents and related supervision and management, and supervising and guiding the registration and filing of local in vitro diagnostic reagents.

Article 6 The Medical Device Technical Evaluation Center of the State Medical Products Administration (hereinafter referred to as the Device Evaluation Center of the State Administration) is responsible for the technical review of domestic Class III and imported Class II and III in vitro diagnostic reagent product registration applications, application for change of registration, and application for renewal of registration.

Other professional and technical institutions such as the Medical Device Standards Management Center of the State Medical Products Administration, the China Institute of Food and Drug Control, the Food and Drug Audit and Inspection Center of the State Medical Products Administration (hereinafter referred to as the Audit and Inspection Center of the State Drug Administration), the Drug Evaluation Center of the State Medical Products Administration, the Administrative Matters Acceptance Service and Complaint Reporting Center of the State Medical Products Administration, and the Information Center of the State Medical Products Administration shall undertake the standard management and classification definition of in vitro diagnostic reagents required for the implementation of the supervision and management of in vitro diagnostic reagents according to their duties , inspection, verification, monitoring and evaluation, certification and delivery, and corresponding information construction and management.

Article 7 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the management of the following in vitro diagnostic reagent registration within their administrative regions

(1) Registration, review and approval of Class II in vitro diagnostic reagents in China;

(2) Verification of the quality management system of Class II and Class III in vitro diagnostic reagents in China;

(3) Organize medical device clinical trial institutions and supervision and management of clinical trials in accordance with the law;

(4) Supervision and guidance on the filing of Class I in vitro diagnostic reagents within the departments responsible for drug supervision and administration at the districted municipal level.

The professional and technical institutions for medical devices set up or designated by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall undertake the technical review, inspection, verification, monitoring and evaluation required for the supervision and management of in vitro diagnostic reagents.

The departments responsible for drug supervision and administration at the districted municipal level are responsible for the filing and management of Class I in vitro diagnostic reagent products in China.

Article 8 The registration and filing of in vitro diagnostic reagents shall follow the principles of law, science, openness, fairness and impartiality.

Article 9 Class I in vitro diagnostic reagents shall be subject to product filing management. Class II and Class III in vitro diagnostic reagents shall be subject to product registration management.

For the filing of the first class of in vitro diagnostic reagents in China, the filer shall submit the filing materials to the department responsible for drug supervision and administration at the districted municipal level.

Class II in vitro diagnostic reagents in China shall be reviewed by the drug administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and a medical device registration certificate shall be issued after approval.

Domestic Class III in vitro diagnostic reagents shall be reviewed by the State Medical Products Administration and issued a medical device registration certificate after approval.

The import of Class I in vitro diagnostic reagents shall be filed, and the filer shall submit the filing materials to the State Medical Products Administration.

Imported Class II and III in vitro diagnostic reagents shall be reviewed by the State Medical Products Administration, and a medical device registration certificate shall be issued after approval.

Article 10 The registrant and filer of in vitro diagnostic reagents shall strengthen the quality management of the whole life cycle of in vitro diagnostic reagents, and shall be responsible for the safety, efficacy, and quality controllability of in vitro diagnostic reagents in the whole process of development, production, operation, and use.

Article 11 The State Medical Products Administration shall give priority to the approval of in vitro diagnostic reagents urgently needed for clinical use, and implement special approval for innovative in vitro diagnostic reagents. Encourage the research and innovation of in vitro diagnostic reagents and promote the high-quality development of the medical device industry.

Article 12 The NMPA shall establish and improve systems such as in vitro diagnostic reagent standards and technical guiding principles in accordance with the law, standardize the technical review and quality management system verification of in vitro diagnostic reagents, and guide and serve the research and development and registration applications of in vitro diagnostic reagents.

Article 13 The drug regulatory department shall promptly disclose the relevant information on the registration and filing of in vitro diagnostic reagents in accordance with the law, and the applicant may inquire about the progress and results of the approval, and the public may consult the approval results.

Without the consent of the applicant, the drug regulatory department, professional and technical institutions and their staff, experts and other personnel participating in the review shall not disclose trade secrets, undisclosed information or confidential business information submitted by the applicant or filer, unless otherwise provided by law or related to national security or major social and public interests.

Chapter 2 Basic Requirements

Article 14 The registration and filing of in vitro diagnostic reagents shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of safety and performance of in vitro diagnostic reagents, and refer to relevant technical guiding principles to prove that the registered and filed in vitro diagnostic reagents are safe, effective, and of controllable quality, and ensure that the information is true, accurate, complete, and traceable.

Article 15 The applicant and filer shall be an enterprise or research and development institution that can bear the corresponding legal responsibility.

Overseas applicants and filers shall designate enterprise legal persons in China as agents to handle the registration and filing of relevant in vitro diagnostic reagents. The agent shall assist the registrant and filer in performing the obligations stipulated in the first paragraph of Article 20 of the Regulations on the Supervision and Administration of Medical Devices in accordance with the law, and assist the overseas registrant and filer in implementing the corresponding legal responsibilities.

Article 16 The applicant and filer shall establish a quality management system related to product development and production, and maintain effective operation.

Article 17 Personnel handling the registration and filing of in vitro diagnostic reagents shall have relevant professional knowledge and be familiar with the laws, regulations, rules, and relevant provisions on the registration and management of in vitro diagnostic reagents.

Article 18 When applying for registration or filing, relevant materials shall be submitted in accordance with the relevant requirements of the State Medical Products Administration, and the applicant and filer shall be responsible for the authenticity of the information.

Registration and filing materials shall be in Chinese. If the translation is based on foreign language materials, the original text shall be provided at the same time. When citing unpublished literature, documents licensed by the material rights holder shall be provided.

Article 19 When applying for registration of imported in vitro diagnostic reagents and filing of imported in vitro diagnostic reagents, the applicant or the filer's place of registration or production shall submit documents proving that the competent authority of the country (region) where the applicant or the filer is registered or where the place of production is approved for listing and sale.

If the country (region) where the applicant or filer is registered or manufactured does not manage the product as a medical device, the applicant or filer must provide relevant documents, including the certificate that the country (region) where the product is registered or manufactured is allowed to be put on the market and sold.

In vitro diagnostic reagents that are not listed in the country (region) where the applicant or filer is registered or where the place of production is approved in accordance with the innovative product registration procedures do not need to submit relevant documents.

Article 20 In vitro diagnostic reagents shall comply with applicable mandatory standards. If the structural characteristics, technical principles, intended use, and usage methods of the product are inconsistent with the scope of application of the mandatory standards, the applicant or filer shall provide an explanation of the non-application of the mandatory standards and provide relevant information.

If there are no mandatory standards, applicants and filers are encouraged to adopt recommended standards.

Article 21 The registration and filing of in vitro diagnostic reagents shall comply with the relevant requirements of the classification rules and classification catalogues of in vitro diagnostic reagents.

Article 22 The drug regulatory departments continue to promote the reform of the review and approval system, strengthen regulatory scientific research, establish a technical system for the registration and management of in vitro diagnostic reagents led by technical review and supported by verification, inspection, monitoring and evaluation, optimize the review and approval process, improve the ability of review and approval, and improve the quality and efficiency of review and approval.

Article 23 Medical device professional and technical institutions shall establish and improve communication systems, clarify the form and content of communication, and organize communication with applicants according to work needs.

Article 24 Medical device professional and technical institutions shall establish an expert consultation system according to work needs, listen to expert opinions on major issues in the process of review, verification, inspection, etc., and give full play to the technical support role of experts.

Chapter 3 Registration of in vitro diagnostic reagents

Section 1 Product development

Article 25 The development of in vitro diagnostic reagents shall follow the principle of risk management, take into account the existing recognized technical level, ensure that all known and foreseeable risks and unintended effects of the product are minimized and acceptable, and ensure that the benefits of the product outweigh the risks in normal use.

Article 26 Engaging in the development and experimental activities of in vitro diagnostic reagent products shall comply with the requirements of relevant laws, regulations and mandatory standards of our country.

Article 27 The applicant and filer shall prepare the technical requirements for the product of in vitro diagnostic reagents for registration or filing.

The technical requirements of the product mainly include the functional, safety indicators and testing methods that can be objectively judged for the finished in vitro diagnostic reagents.

The product technical requirements for the third type of in vitro diagnostic reagents shall specify the main raw materials and production process requirements in the form of appendices.

In vitro diagnostic reagents shall meet the technical requirements of registered or filed products.

Article 28 The applicant and the filer shall prepare the product instructions and labels for in vitro diagnostic reagents for registration or filing.

Product instructions and labels shall comply with the requirements of Article 39 of the Regulations on the Supervision and Administration of Medical Devices and relevant provisions.

Article 29 The development of in vitro diagnostic reagents shall carry out non-clinical research on in vitro diagnostic reagents according to the intended use and technical characteristics of the product.

Non-clinical research refers to the test or evaluation of in vitro diagnostic reagents under laboratory conditions, including the selection and preparation of main raw materials, product production process, product analytical performance, positive judgment value or reference interval, product stability, etc.

When applying for registration or filing, non-clinical evidence generated from research and development activities shall be submitted.

Article 30 The functional and safety indicators and methods determined in the non-clinical research process of in vitro diagnostic reagents shall be compatible with the expected conditions and purposes of the product, and the research samples shall be representative and typical. When necessary, methodological verification and statistical analysis shall be conducted.

Article 31 The application for registration or filing shall be inspected in accordance with the technical requirements of the product and the inspection report shall be submitted. Only those who pass the inspection can carry out clinical trials or apply for registration and filing.

Article 32 When the same registration application includes different packaging specifications, only one packaging specification product may be inspected, and the product for inspection shall be able to represent the safety and effectiveness of the product applied for registration or recorded, and its production shall comply with the relevant requirements of the Good Manufacturing Management Code for medical devices.

Article 33 The inspection report submitted for registration or filing may be the self-inspection report of the applicant or the filer, or the inspection report issued by a qualified medical device inspection agency.

Class III in vitro diagnostic reagents shall provide inspection reports for three different production batches.

Article 34 For applicable national standards, national standards shall be used to test the reagents. China Institute of Food and Drug Control is responsible for organizing the preparation and calibration of national standards.

Section 2 Clinical evaluation

Article 35 Clinical evaluation of in vitro diagnostic reagents refers to the process of analyzing and evaluating clinical data using scientific and reasonable methods, and confirming whether the product meets the requirements for use or intended use, so as to prove the safety and effectiveness of in vitro diagnostic reagents.

Article 36 Clinical trials of in vitro diagnostic reagents refer to systematic research on the clinical performance of in vitro diagnostic reagents in the corresponding clinical environment.

The NMPA formulates guidelines for clinical trials of in vitro diagnostic reagents, clarifying the requirements for conducting clinical trials and the requirements for writing clinical trial reports.

Article 37 Clinical evaluation of in vitro diagnostic reagents shall be carried out to prove the safety and efficacy of in vitro diagnostic reagents.

Clinical trials can be exempted from clinical trials under the following circumstances:

(1) The reaction principle is clear, the design is finalized, the production process is mature, and the in vitro diagnostic reagents of the same variety that have been marketed for many years have been used clinically without serious adverse events and have not changed their conventional use;

(2) The in vitro diagnostic reagent can be proved to be safe and effective by methodological comparison of the same variety.

The catalogue of Class II and III in vitro diagnostic reagents exempt from clinical trials shall be formulated, adjusted and published by the State Medical Products Administration.

Article 38 For in vitro diagnostic reagents exempted from clinical trials, the applicant shall prove the safety and effectiveness of the product by methodologically comparing clinical samples with the same variety that meet the intended use.

The NMPA has formulated guidelines for the clinical evaluation of in vitro diagnostic reagents that are exempt from clinical trials.

Article 39 Clinical evaluation data of in vitro diagnostic reagents refer to the documents formed by the applicant's clinical evaluation.

If a clinical trial is conducted, the clinical trial data includes the clinical trial protocol, ethics committee opinion, informed consent form, clinical trial report and relevant data.

For in vitro diagnostic reagents included in the list of clinical trials, clinical evaluation data include comparative analysis with similar marketed products, methodological comparison data, relevant literature data analysis and empirical data analysis.

Article 40 When the same registration application includes different packaging specifications, only one packaging specification may be used for clinical evaluation, and the products used for clinical evaluation shall represent the safety and effectiveness of the products applied for registration or recorded.

Calibrators and quality control products do not need to submit clinical evaluation materials for separate registration.

Article 41 Clinical trials of in vitro diagnostic reagents shall be carried out in medical device clinical trial institutions that meet the corresponding conditions and are filed in accordance with regulations in accordance with the requirements of the quality management standards for clinical trials of medical devices. Before the start of clinical trials, clinical trial sponsors shall file clinical trials with the drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government where they are located. The production of in vitro diagnostic reagents for clinical trials shall comply with the relevant requirements of the Good Manufacturing Practices for Medical Devices.

Article 42 For serious adverse events related to in vitro diagnostic reagents or other serious safety risk information that occur during the clinical trial of in vitro diagnostic reagents, the clinical trial sponsor shall report to the drug regulatory departments of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located in accordance with relevant requirements, and take risk control measures. If risk control measures are not taken, the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall order the applicant to take corresponding risk control measures in accordance with the law.

Article 43 In the event of serious adverse events related to in vitro diagnostic reagents or other major safety issues in the clinical trial of in vitro diagnostic reagents, the sponsor shall suspend or terminate the clinical trial of in vitro diagnostic reagents, and report to the drug regulatory departments of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located. if it is not suspended or terminated, the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall order the applicant to take corresponding risk control measures in accordance with the law.

Article 44 When conducting clinical evaluation of in vitro diagnostic reagents intended for personal use by consumers, the applicant shall also evaluate the cognitive ability of consumers without medical background on the product instructions.

Article 45 For in vitro diagnostic reagents that are undergoing clinical trials for the diagnosis of seriously life-threatening diseases for which there are no effective diagnostic methods, they may be used free of charge by other patients with the same condition in the institution conducting clinical trials of in vitro diagnostic reagents after ethical review and informed consent, and their safety data may be used for registration applications of in vitro diagnostic reagents.

Section 3 Verification of Registration System

Article 46 The applicant shall submit relevant materials related to the quality management system related to product development and production when applying for registration, and if the drug regulatory department accepting the registration application deems it necessary to verify the quality management system during the technical review of the product, it shall organize and carry out the quality management system verification, and may access the original materials as needed.

Article 47 The verification of the quality management system of Class III in vitro diagnostic reagents in China shall be carried out by the drug regulatory authorities of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

The verification of the quality management system of Class II in vitro diagnostic reagents in China shall be organized and carried out by the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.

Article 48 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall carry out quality management system verification in accordance with the requirements of the medical device production quality management specifications, focusing on whether the applicant has established a quality management system suitable for the product in accordance with the requirements of the medical device production quality management specifications, as well as the design and development, production management, quality control, etc. related to product development and production.

During the verification process, the authenticity of the test products and clinical trial products shall be verified at the same time, focusing on the relevant records of the design and development process, as well as the relevant records of the production process of the test products and clinical trial products.

If a self-inspection report is submitted, the applicant, filer, or entrusted institution shall conduct key verification of the inspection capabilities and test results in the development process.

Article 49 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may carry out quality management system verification by means of data review or on-site inspection. According to the specific situation of the applicant, the supervision and inspection, and the comparison between the production conditions and processes of the products applied for registration this time and the products that have been verified in the past, determine whether to conduct on-site inspections and the content of the inspection to avoid repeated inspections.

Article 50 When the Device Evaluation Center of the State Bureau conducts technical review of imported Class II and Class III in vitro diagnostic reagents, it shall notify the State Bureau Audit and Inspection Center to carry out the verification in accordance with relevant requirements.

Section 4 Product Registration

Article 51 After completing the safety and efficacy research supporting the registration of in vitro diagnostic reagents and preparing to accept the verification of the quality management system, the applicant shall submit the following registration application materials to the drug regulatory authorities through online registration applications and other channels in accordance with relevant requirements:

(1) Product risk analysis data;

(2) Product technical requirements;

(3) Product inspection report;

(4) Clinical evaluation data;

(5) Product manual and label sample;

(6) Quality management system documents related to product development and production;

(7) Other materials required to prove the safety and effectiveness of the product.

Article 52 After receiving the application, the drug regulatory department shall review the application materials and handle them according to the following circumstances:

(1) If the application matters fall within the scope of the administrative organ's authority, and the application materials are complete and meet the requirements of formal review, they shall be accepted;

(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;

(3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed of all the contents that need to be supplemented and corrected on the spot or within 5 days.

(4) If the application is not within the scope of the administrative organ's authority in accordance with the law, it shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative organ.

When accepting or rejecting an application for registration of in vitro diagnostic reagents, the drug regulatory department shall issue a notice of acceptance or rejection stamped with the special seal of the administrative organ and indicating the date.

After the application for registration of in vitro diagnostic reagents is accepted, if the applicant is required to pay a fee, the applicant shall pay the fee in accordance with the regulations. If the applicant fails to pay the fee within the specified time limit, the applicant shall be deemed to have voluntarily withdrawn the application, and the drug regulatory department shall terminate the registration procedure.

Article 53 If the applicant needs to supplement and correct the materials during the technical review process, the technical review body shall inform the applicant of all the contents that need to be supplemented and corrected at one time. The applicant shall provide supplementary information once in accordance with the requirements of the supplementary notice within one year of receiving the supplementary notice. After receiving the supplementary information, the technical review body shall complete the technical review within the specified time limit.

If the applicant has any objections to the content of the supplementary notice, he or she may submit written opinions to the corresponding technical review agency, explaining the reasons and providing corresponding technical support materials.

If the applicant fails to submit supplementary information within the time limit, the technical review shall be terminated, and the drug regulatory department shall make a decision not to register.

Article 54 For accepted registration applications, the applicant may apply to the drug regulatory department accepting the application for withdrawal of the registration application and relevant materials before the administrative licensing decision is made, and explain the reasons. If the applicant agrees to withdraw the application, the drug administration department shall terminate the registration procedure.

If it is found that there are suspected illegal acts such as concealing the true situation or providing false information during the review, verification, and approval, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the registration application.

Article 55 For accepted registration applications, if there is evidence that the registration application materials may be false, the drug administration department may suspend the review and approval. After verification, continue the review or make a decision not to register based on the verification conclusions.

Article 56 During the review period of the application for registration of in vitro diagnostic reagents, if the review conclusion is to be rejected, the technical review agency shall inform the applicant of the reasons for the failure, and the applicant may raise an objection to the technical review agency within 15 days, and the objection content shall be limited to the original application items and original application materials. The technical review agency shall conduct a comprehensive evaluation based on the applicant's objections and provide feedback to the applicant. The objection processing time is not included in the review time limit.

Article 57 The drug regulatory department accepting the registration application shall make a decision on whether to approve it after the technical review is completed. Those that meet the requirements of safety, effectiveness and quality controllability will be approved for registration, issued a medical device registration certificate, and the approved product technical requirements and product instructions will be issued to the applicant in the form of attachments. If registration is not granted, the reasons shall be explained in writing, and the applicant shall be informed of the right to apply for administrative reconsideration or initiate administrative litigation in accordance with the law.

The medical device registration certificate is valid for 5 years.

Article 58 For the accepted registration application, under any of the following circumstances, the drug regulatory department shall make a decision not to register and inform the applicant:

(1) The applicant's research on the safety, efficacy, and quality controllability of the in vitro diagnostic reagents to be marketed and the results cannot prove that the product is safe, effective, and of controllable quality;

(2) The quality management system verification fails, and the applicant refuses to accept the on-site inspection of the quality management system;

(3) The registration application materials are false;

(4) The content of the registration application materials is confusing or contradictory, and the content of the registration application materials is obviously inconsistent with the application items, and it cannot prove that the product is safe, effective, and the quality is controllable;

(5) Other circumstances in which registration is not allowed.

Article 59 The drug administration department shall announce to the public and hold hearings on matters that laws, regulations, and rules stipulate that the implementation of administrative licensing shall be heard, or other major administrative licensing matters involving public interest that the drug administration department deems necessary to be heard. If the medical device registration application directly involves a major interest relationship between the applicant and others, the drug regulatory department shall inform the applicant and interested parties of their right to request a hearing before making an administrative licensing decision.

Article 60 The drug regulatory authorities may make conditional approval decisions for in vitro diagnostic reagents that are urgently needed for rare diseases, seriously life-threatening diseases for which there is no effective diagnostic means, and respond to public health events, and specify in the medical device registration certificate the validity period, research work that needs to be completed after marketing, completion time limit, and other relevant matters.

Article 61 For conditionally approved in vitro diagnostic reagents, the registrant shall collect data on benefits and risks after the in vitro diagnostic reagents are listed, continue to monitor and evaluate the benefits and risks of the product, take effective measures to actively control risks, and complete the study and submit relevant materials within the specified time limit as required.

Article 62 For conditionally approved in vitro diagnostic reagents, if the registrant fails to complete the research as required within the time limit or fails to prove that the benefits outweigh the risks, the registrant shall promptly apply for the cancellation of the medical device registration certificate, and the drug regulatory department may cancel the medical device registration certificate in accordance with the law.

Article 63 For newly developed in vitro diagnostic reagents that have not yet been included in the classification catalogue of in vitro diagnostic reagents, the applicant may directly apply for the registration of the third class of in vitro diagnostic reagent products, or may apply for product registration or product filing after determining the product category according to the classification rules and applying to the State Medical Products Administration for category confirmation.

If the third class of in vitro diagnostic reagents are directly applied for registration, the State Medical Products Administration shall determine the category according to the degree of risk. If domestic in vitro diagnostic reagents are determined to be Class II or Class I, the applicant shall be informed to apply for registration or filing with the corresponding drug regulatory department.

Article 64 If the management category of registered in vitro diagnostic reagents is adjusted from high category to low category, the medical device registration certificate shall continue to be valid during the validity period. If the validity period expires and needs to be renewed, the registrant shall apply to the corresponding drug regulatory department for renewal of registration or filing according to the adjusted category 6 months before the expiration of the validity period of the medical device registration certificate.

If the management category of in vitro diagnostic reagents is adjusted from a low category to a high category, the registrant shall apply to the corresponding drug regulatory department for registration according to the changed category. The State Medical Products Administration shall stipulate the time limit for completing the adjustment in the notice of adjustment of management categories.

Article 65 If the medical device registration certificate and its accessories are lost or damaged, the registrant shall apply to the original issuing authority for reissuance, and the original issuing authority shall verify the reissuance of the certificate.

Article 66 Any patent dispute that arises during the examination process and after approval of the registration application shall be handled in accordance with the provisions of relevant laws and regulations.

Chapter 4 Special Registration Procedures

Section 1 Innovative Product Registration Procedures

Article 67 For in vitro diagnostic reagents that meet the following requirements, the applicant may apply for the registration procedures for innovative products:

(1) The applicant has a patent right for the invention of the core technology of a product in China in accordance with the law through the technological innovation activities led by the applicant, or obtains the invention patent right or the right to use it in China through the transfer of the law in accordance with the law, and the time to apply for the application of the registration procedure for innovative products is within 5 years from the date of the patent authorization announcement; or the application for core technology invention patent has been disclosed by the patent administration department of the State Council, and the search report issued by the Patent Search and Consulting Center of the State Intellectual Property Office indicates that the core technology solution of the product has novelty and inventiveness;

(2) The applicant has completed the preliminary research of the product and has a basic finalized product, the research process is real and controlled, and the research data is complete and traceable;

(3) The main working principle or mechanism of the product is the first in China, and the product performance or safety has been fundamentally improved compared with similar products, and the technology is at the international leading level, and has significant clinical application value.

Article 68 When applying for the application of innovative product registration procedures, the applicant shall submit an application for review of innovative medical devices to the State Medical Products Administration after the product is basically finalized. The State Medical Products Administration organizes experts to conduct reviews, and those that meet the requirements will be included in the registration procedures for innovative products.

Article 69 For the registration application of in vitro diagnostic reagents applicable to the registration procedures of innovative products, the State Medical Products Administration and the institutions undertaking relevant technical work shall designate special personnel to be responsible according to their respective responsibilities, communicate in a timely manner, and provide guidance.

For in vitro diagnostic reagents included in the registration procedure of innovative products, the Device Evaluation Center of the State Bureau can communicate with the applicant on major technical issues, major safety issues, clinical trial plans, and summary and evaluation of phased clinical trial results in product development before accepting the registration application and during the technical review process.

Article 70 If the applicant voluntarily requests termination of the in vitro diagnostic reagents included in the innovative product registration procedures or the NMPA finds that they no longer meet the requirements of the innovative product registration procedures, the NMPA may terminate the innovative product registration procedures of the relevant products and inform the applicant.

Article 71 For in vitro diagnostic reagents included in the registration procedures for innovative products, if the applicant fails to apply for registration within the specified time limit, the registration procedures for innovative products shall no longer apply.

Section 2 Priority Registration Procedures

Article 72 In vitro diagnostic reagents that meet one of the following conditions may apply for priority registration procedures:

(1) Medical devices that diagnose rare diseases and malignant tumors and have obvious clinical advantages, diagnose endemic and frequent diseases of the elderly and have no effective diagnostic methods, are exclusively used in children and have obvious clinical advantages, or are urgently needed clinically and there are no products of the same variety approved for registration in our country;

(2) Medical devices included in major national science and technology projects or national key research and development plans;

(3) Other medical devices stipulated by the State Medical Products Administration that can be subject to priority registration procedures.

Article 73 Where applying for priority registration procedures, the applicant shall submit to the State Medical Products Administration the application for priority registration procedures when submitting an application for registration of in vitro diagnostic reagentsApplication. If it falls under the situation of Article 72, paragraph 1, the State Medical Products Administration shall organize experts to conduct a review, and if it meets the requirements, it shall be included in the priority registration procedure; If it falls under the second situation of Article 72, it shall be reviewed by the Device Evaluation Center of the State Bureau, and if it is met, it shall be included in the priority registration procedure; In the case of Article 72, item 3, the State Medical Products Administration shall listen to opinions extensively and organize expert demonstrations to determine whether to include in the priority registration procedure.

Article 74 For the registration application of in vitro diagnostic reagents included in the priority registration procedure, the State Medical Products Administration shall give priority to review and approve, and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall give priority to arranging the verification of the registration quality management system.

In the process of technical review of medical device products included in the priority registration procedure, the Device Evaluation Center of the State Bureau shall actively communicate with the applicant in accordance with relevant regulations, and if necessary, arrange special exchanges.

Section 3 Emergency registration procedures

Article 75 The NMPA may implement emergency registration in accordance with the law for in vitro diagnostic reagents that are required for emergency response to public health emergencies and are not yet marketed in our country, or that are not available in our country but cannot meet the needs of emergency treatment of public health emergencies.

Article 76 When applying for emergency registration procedures, the applicant shall submit an application for emergency registration to the State Medical Products Administration. Those who meet the requirements will be included in the emergency registration procedure.

Article 77 The State Medical Products Administration shall handle the registration application for in vitro diagnostic reagents for emergency registration in accordance with the requirements of unified command, early intervention, on-the-spot review, and scientific approval, and carry out in parallel the inspection, system verification, and technical review of in vitro diagnostic reagent products.

Chapter 5 Change of Registration and Renewal of Registration

Section 1 Change of registration

Article 78 The registrant shall take the initiative to carry out post-market research on in vitro diagnostic reagents, further confirm the safety, efficacy, and quality controllability of in vitro diagnostic reagents, and strengthen the continuous management of marketed in vitro diagnostic reagents.

If the design, raw materials, production process, scope of application, and usage methods of registered Class II and III in vitro diagnostic reagent products undergo substantial changes, which may affect the safety and effectiveness of the in vitro diagnostic reagents, the registrant shall apply to the original registration department for change of registration procedures; If other changes occur, they shall be filed with the original registration department within 30 days from the date of change.

The product name, packaging specifications, main components, intended use, product technical requirements, product manual, production address of imported in vitro diagnostic reagents, etc. specified in the registration certificate are matters that need to be changed and registered as stipulated in the preceding paragraph. The name and domicile of the registrant, the name and domicile of the agent, etc., are the matters that need to be filed as stipulated in the preceding paragraph. If the production address of in vitro diagnostic reagents in China is changed, the registrant shall file the record after handling the corresponding change in the production license.

If other changes occur, the registrant shall do a good job in accordance with the requirements of the quality management system and report to the drug regulatory department in accordance with the regulations.

Article 79 Registered Class II and III in vitro diagnostic reagents, if the core technical principles of the product undergo substantial changes, or other major changes that have a significant impact on the safety and effectiveness of the product, and constitute a new product in substance, they are not part of the change application provided for in this Chapter and shall be handled in accordance with the provisions of the registration application.

Article 80 For the application for change of registration, the technical review agency shall focus on the review of the changed parts, and form an evaluation opinion on whether the changed product is safe, effective and controllable.

When conducting a technical review of the change of registration application, if it is deemed necessary to verify the quality management system, the drug regulatory department shall organize and carry out the quality management system verification.

Article 81 The medical device change registration document shall be used in conjunction with the original medical device registration certificate, and the validity period shall be the same as that of the original medical device registration certificate.

Section 2 Renewal of Registration

Article 82 If the validity period of the medical device registration certificate expires and the registration needs to be renewed, the registrant shall apply to the original registration department for renewal of registration 6 months before the expiration of the validity period of the medical device registration certificate, and submit the application materials in accordance with relevant requirements.

Except for the circumstances provided for in Article 83 of these Measures, the drug regulatory department receiving the application for renewal of registration shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. if no decision is made within the time limit, it shall be deemed to be allowed to continue.

Article 83 In any of the following circumstances, the registration shall not be renewed:

(1) Failure to submit an application for renewal of registration within the prescribed time limit;

(2) New mandatory standards for in vitro diagnostic reagents or national standards are issued and implemented, and the in vitro diagnostic reagents applying for renewal of registration cannot meet the new requirements;

(3) Conditionally approved in vitro diagnostic reagents that fail to complete the matters specified in the medical device registration certificate within the specified time limit.

Article 84 If the approval time for renewal of registration is within the validity period of the original registration certificate, the starting date of the validity period of the registration certificate for renewal of registration shall be the day after the expiration date of the original registration certificate; if the approval time is not within the validity period of the original registration certificate, the starting date of the validity period of the registration certificate for renewal of registration shall be the date on which the renewal of registration is approved

Article 85 The relevant provisions of Chapter 3 of these Measures shall apply to the acceptance and approval procedures for the application for change of registration and renewal of registration of in vitro diagnostic reagents if not provided for in this Chapter.

Chapter VI In Vitro Diagnostic Reagent Filing

Article 86 Before the production of Class I in vitro diagnostic reagents, the product shall be recorded.

Article 87 For the filing of in vitro diagnostic reagents, the filer shall submit the filing materials to the drug regulatory department in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices and obtain the filing number.

Article 88 If there is a change in the content of the filing information table and the technical requirements of the filed product for the in vitro diagnostic reagents that have been recorded, the filer shall change the filing to the original filing department and submit an explanation of the change and relevant documents. The drug administration department shall publish the changes in the filing information.

Article 89 Where the management category of in vitro diagnostic reagents that have been filed is adjusted to Class II or Class III in vitro diagnostic reagents, registration shall be applied for in accordance with the provisions of these Measures.

Chapter 7 Work Time Limit

Article 90 The time limit stipulated in these Measures is the maximum time for the acceptance, technical review, verification, and approval of in vitro diagnostic reagent registration. The work time limit related to special registration procedures shall be implemented in accordance with the relevant provisions of special registration procedures.

Professional and technical institutions such as the Device Evaluation Center of the State Bureau shall clarify the work procedures and time limits of their own units and announce them to the public.

Article 91 After receiving the application for registration of in vitro diagnostic reagents, the drug regulatory department shall transfer the application materials to the technical review agency within 3 days from the date of acceptance.

Article 92 The time limit for technical review of in vitro diagnostic reagent registration shall be implemented in accordance with the following provisions:

(1) The time limit for technical review of applications for registration, change of registration, and renewal of registration of Class II in vitro diagnostic reagents is 60 days, and the time limit for technical review after supplementing and correcting the application materials is 60 days;

(2) The technical review time limit for registration applications, registration change applications, and renewal registration applications for Class III in vitro diagnostic reagents is 90 days, and the technical review time limit after supplementing and correcting the application materials is 60 days.

Article 93 The time limit for the verification of the quality management system of Class III in vitro diagnostic reagents in China shall be implemented in accordance with the following provisions:

(1) The Device Evaluation Center of the State Administration shall notify the relevant provincial, autonomous region, and municipal drug regulatory departments to initiate verification within 10 days after accepting the application for registration of in vitro diagnostic reagents;

(2) In principle, the provincial, autonomous region, and municipal drug regulatory departments shall complete the verification within 30 days after receiving the verification notice, and feed back the verification situation, verification results and other relevant materials to the National Bureau Device Evaluation Center.

Article 94 The drug regulatory department accepting the registration application shall make a decision within 20 days from the date of receipt of the review opinion.

Article 95 The drug regulatory department shall issue and deliver the relevant administrative license within 10 days from the date of making the decision on the registration and approval of in vitro diagnostic reagents.

Article 96 If it is really necessary to extend the time limit due to special circumstances such as product characteristics and technical review and verification, the extension time limit shall not exceed one-half of the original time limit.

Article 97 The original issuing authority shall reissue the medical device registration certificate within 20 days from the date of receipt of the application for reissuance.

Article 98 The following hours are not included in the relevant work time limits:

(1) The time occupied by the applicant for supplementary information, rectification after verification, etc.;

(2) The time for delaying verification due to the applicant's reasons;

(3) The time for external expert consultation, expert consultation meetings, and joint review with drug evaluation agencies;

(4) If the review and approval procedures are suspended in accordance with regulations, the time occupied during the suspension of the review and approval procedures;

(5) The time occupied by the quality management system verification.

Article 99 The time limit stipulated in these Measures shall be calculated on working days.

Chapter VIII: Supervision and Management

Article 100 The drug regulatory departments shall strengthen supervision and inspection of in vitro diagnostic reagent development activities, and when necessary, may conduct extended inspections of units and individuals providing products or services for the development of in vitro diagnostic reagents.

Article 101 The State Medical Products Administration shall establish and implement the unique identification system for medical devices step by step, and the applicant and filer shall submit relevant information on the unique identification in accordance with relevant provisions to ensure that the data is true, accurate and traceable.

Article 102 The State Medical Products Administration shall promptly notify the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the agent is located. The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall carry out daily supervision and management of agent organizations in their administrative regions.

Article 103 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize post-filing supervision and inspection of clinical trial institutions that have been registered in their respective administrative regions based on the filing of medical device clinical trial institutions. For newly registered medical device clinical trial institutions, supervision and inspection shall be carried out within 60 days after filing.

The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize daily supervision and inspection of the compliance of medical device clinical trial quality management standards by medical device clinical trial institutions within their administrative regions, and supervise their continuous compliance with the prescribed requirements. The State Medical Products Administration shall supervise and inspect medical device clinical trial institutions as needed.

Article 104 If the drug administration department deems it necessary, it may conduct on-site inspections of the authenticity, accuracy, completeness, standardization, and traceability of clinical trials.

Article 105 If the drug regulatory department responsible for the filing of Class I in vitro diagnostic reagent products finds that the filing materials are not standardized during post-filing supervision, it shall order the filer to make corrections within a time limit.

Article 106 Where the drug regulatory department fails to promptly discover the systemic or regional risks of the registration and management of in vitro diagnostic reagents within its administrative region, or fails to eliminate the systemic or regional hidden dangers in the registration and management of in vitro diagnostic reagents within its administrative region, the higher-level drug regulatory department may conduct an interview with the principal responsible person of the lower-level drug regulatory department.

Chapter 9 Legal Liability

Article 107 Where the provisions of Article 78 of these Measures are violated and the changes are not filed in accordance with the requirements, corrections shall be ordered within a time limit; if corrections are not made within the time limit, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed.

Article 108 Where clinical trials of in vitro diagnostic reagents fail to comply with clinical trial quality management norms, they shall be punished in accordance with Article 94 of the Regulations on the Supervision and Administration of Medical Devices.

Article 109 Where a medical device technical review agency fails to perform its duties in accordance with the provisions of these Measures, resulting in major mistakes in the review work, the department responsible for drug supervision and administration shall order corrections, report criticism, and give warnings; Where serious consequences are caused, the legal representative, principal responsible person, directly responsible manager, and other responsible personnel of the illegal unit shall be punished in accordance with law.

Article 110 Staff of departments responsible for drug supervision and administration who violate regulations, abuse their power, neglect their duties, or engage in corruption for personal gain shall be punished in accordance with law.

Chapter 10 Supplementary Provisions

Article 111 The naming of in vitro diagnostic reagents shall follow the following principles:

The product name of in vitro diagnostic reagents generally consists of three parts. Part I: Name of the substance to be tested; Part 2: Purpose, such as assay kits, quality controls, etc.; Part 3: Methods or principles, such as magnetic particle chemiluminescence immunoassay, fluorescence PCR method, fluorescence in situ hybridization, etc., should be listed in parentheses.

If there are many components of the test object or other special circumstances, the name of the indication related to the product or other alternative names can be used.

The first type of products, calibrators, and quality control products are named according to their intended use.

Article 112 The registration or filing unit of in vitro diagnostic reagents shall be a single reagent or a single kit, and a registration or filing unit may include different packaging specifications.

Calibrators and quality control products can be applied for registration together with in vitro diagnostic reagents used together, or they can be applied for registration separately.

Article 113 In vitro diagnostic reagents approved for registration refer to in vitro diagnostic reagents produced within the validity period of the medical device registration certificate and accessories consistent with the medical device registration certificate and accessories.

Article 114 The independent reagent components specified in the "main components" column of the medical device registration certificate may be sold separately if they are used in the original registered product.

Article 115 The applicant may use the registered master file of the medical device with the authorization of the owner of the master file of the medical device when applying for registration or change of registration of in vitro diagnostic reagent products. The master file of medical devices shall be registered by its owner or agency, and relevant work procedures shall be stipulated separately.

Article 116 The format of the medical device registration certificate shall be uniformly formulated by the State Medical Products Administration.

The registration certificate number is arranged as follows:

×1 Device Note × 2××××3×4××5××××6. Where:

×1 is the abbreviation of the location of the registration and approval department:

Domestic Class III in vitro diagnostic reagents, imported Class II and III in vitro diagnostic reagents are "country";

The second type of in vitro diagnostic reagents in China is the abbreviation of the province, autonomous region or municipality directly under the Central Government where the registration and approval department is located;

×2 is the form of registration:

The word "quasi" is applicable to domestic in vitro diagnostic reagents;

The word "enter" is applicable to imported in vitro diagnostic reagents;

The word "Xu" is applicable to in vitro diagnostic reagents in Hong Kong, Macao and Taiwan;

××××3 is the year of first registration;

×4 is the product management category;

××5 is the product classification code;

××××6 is the first registration serial number.

If the registration is renewed, the numbers ×××× 3 and ××××6 remain unchanged. If the product management category is adjusted, it shall be renumbered.

Article 117 The filing number of Class I medical devices is arranged as follows:

×1 Equipment ×××× 2××××3.

Thereinto:

×1 is the abbreviation of the location of the filing department:

imported Class I in vitro diagnostic reagents are "country";

The first type of in vitro diagnostic reagents in China are the abbreviation of the province, autonomous region, or municipality where the filing department is located plus the abbreviation of the districted municipal administrative region where the filing department is located (if there is no corresponding districted municipal administrative region, it is only the abbreviation of the province, autonomous region, or municipality directly under the Central Government).

××××2 is the filing year;

××××3 is the record serial number.

Article 118 The electronic documents of medical device registration certificates and registration change documents prepared by the drug regulatory department shall have the same legal effect as paper documents.

Article 119 According to the needs of the work, the State Medical Products Administration may entrust the drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government or technical institutions or social organizations to undertake relevant specific work in accordance with the law.

Article 120 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government may refer to the provisions of Chapter 4 of these Measures to formulate special registration procedures for Class II in vitro diagnostic reagents within their administrative regions, and report them to the State Medical Products Administration for the record.

Article 121 The registration fees and charging standards for in vitro diagnostic reagent products shall be implemented in accordance with the relevant provisions of the finance and price departments of the State Council.

Article 122 The relevant regulations on the emergency use of in vitro diagnostic reagents shall be formulated separately by the State Medical Products Administration in conjunction with relevant departments.

Article 123 For in vitro diagnostic reagents developed by medical institutions according to the clinical needs of their own units and used in their own units under the guidance of practicing physicians, the relevant management regulations shall be separately formulated by the State Medical Products Administration in conjunction with relevant departments.

Article 124 The registration and filing of in vitro diagnostic reagents in Hong Kong, Macao and Taiwan shall be handled with reference to imported in vitro diagnostic reagents.

Article 125 These Measures shall come into force on October 1, 2021. On July 30, 2014, the "Administrative Measures for the Registration of in Vitro Diagnostic Reagents" promulgated by the former State Food and Drug Administration Order No. 5 was repealed at the same time.