Chapter 1 General Provisions

Article 1 In order to standardize the registration and filing of medical devices and ensure the safety, effectiveness and controllable quality of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Article 2 These Measures apply to medical device registration, filing, and supervision and management activities within the territory of the People's Republic of China.

Article 3 Medical device registration refers to the activity in which the medical device registration applicant (hereinafter referred to as the applicant) submits an application for medical device registration in accordance with legal procedures and requirements, and the drug regulatory 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.

Medical device filing refers to the activity of the medical device filer (hereinafter referred to as the filer) submitting 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 4 The State Medical Products Administration is responsible for the national medical device registration and filing management, establishing a medical device registration and filing management system and system, organizing the review and approval of domestic Class III and imported Class II and Class III medical devices in accordance with the law, and supervising and guiding the registration and filing of local medical devices.

Article 5 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 clinical trial applications of medical devices that require clinical trial approval, as well as the technical review of domestic Class III and imported Class II and Class III medical device product registration, registration change applications, and renewal registration applications.

Medical Device Standard Management Center of the State Drug Administration, China Institute of Food and Drug Control, 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), Drug Evaluation Center of the State Drug Administration, Administrative Matters Acceptance Service and Complaint Reporting Center of the State Medical Products Administration, Information Center of the State Medical Products Administration and other professional and technical institutions, according to their duties and responsibilities to undertake the medical device standard management, classification definition, inspection, Verification, monitoring and evaluation, certification and delivery, and corresponding information construction and management.

Article 6 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the management of the following medical device registration within their administrative regions

(1) Registration, review and approval of domestic Class II medical devices;

(2) Verification of the quality management system of domestic Class II and Class III medical devices;

(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 medical devices in the territory of the departments responsible for drug supervision and administration at the districted municipal level.

The professional and technical institutions for medical devices established 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 implementation of medical device supervision and management.

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

Article 7 The registration and filing management of medical devices shall follow the principles of law, science, openness, fairness and impartiality.

Article 8 Class I medical devices shall be subject to product filing management. Class II and Class III medical devices are subject to product registration management.

For the filing of Class I medical devices 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 medical devices in China shall be reviewed by the drug regulatory 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 medical devices shall be reviewed by the State Medical Products Administration and issued a medical device registration certificate after approval.

For the filing of imported Class I medical devices, the filer shall submit the filing materials to the State Medical Products Administration.

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

Article 9 Medical device registrants and filers shall strengthen the quality management of the entire life cycle of medical devices, and be responsible for the safety, effectiveness and quality controllability of medical devices in the whole process of development, production, operation and use in accordance with the law.

Article 10 The State Medical Products Administration shall give priority to the approval of medical devices urgently needed in clinical practice, and implement special approval for innovative medical devices, encourage the research and innovation of medical devices, and promote the high-quality development of the medical device industry.

Article 11 The State Medical Products Administration shall establish and improve medical device standards, technical guiding principles and other systems in accordance with the law, standardize the technical review of medical devices and the verification of quality management systems, and guide and serve the research and development and registration application of medical devices.

Article 12 The drug regulatory department shall promptly disclose relevant information on the registration and filing of medical devices 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 13 The registration and filing of medical devices shall comply with relevant laws, regulations, rules, and mandatory standards, follow the basic principles of medical device safety and performance, and refer to relevant technical guiding principles to prove that the registered and filed medical devices are safe, effective, and of controllable quality, and ensure that the information in the whole process is true, accurate, complete, and traceable.

Article 14 The applicant and filer shall be an enterprise or research and development institution that can bear corresponding legal responsibilities.

Overseas applicants and filers shall designate enterprise legal persons in China as agents to handle relevant medical device registration and filing matters. 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 15 The applicant and the filer shall establish a quality management system suitable for the product and maintain effective operation.

Article 16 Personnel handling medical device registration and filing matters shall have corresponding professional knowledge and be familiar with the laws, regulations, rules, and relevant provisions on registration management of medical device registration and filing.

Article 17 When applying for registration or filing, relevant materials shall be submitted in accordance with the requirements of the State Drug Administration for registration and filing, 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 18 When applying for registration of imported medical devices and filing of imported medical devices, the applicant or the competent department of the country (region) where the place of registration or production is located shall submit the documents proving that the medical device 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.

Innovative medical devices that are not listed in the country (region) where the applicant or filer is registered or where the place of production are located do not need to submit relevant documents.

Article 19 Medical devices shall comply with applicable mandatory standards. If the structural characteristics, 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 20 The registration and filing of medical devices shall comply with the relevant requirements of the medical device classification rules and classification catalogs.

Article 21 The drug regulatory authorities continue to promote the reform of the review and approval system, strengthen scientific research on medical device supervision, establish a medical device registration management technical system 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 22 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 23 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 III Medical Device Registration

Section 1 Product development

Article 24 The development of medical devices 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 25 Engaging in medical device product development and experimental activities shall comply with the requirements of relevant laws, regulations and mandatory standards of our country.

Article 26 The applicant and filer shall prepare the technical requirements for the product of the medical device for registration or filing.

Product technical requirements mainly include the functionality, safety indicators and testing methods that can be objectively judged for the finished medical device.

Medical devices shall meet the technical requirements of registered or filed products.

Article 27 The applicant and filer shall prepare the product instructions and labels of medical devices 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 28 The development of medical devices shall carry out non-clinical research on medical devices according to the scope of application and technical characteristics of the product.

Non-clinical research includes product chemical and physical properties research, electrical safety research, radiation safety research, software research, biological properties research, biogenic material safety research, disinfection and sterilization process research, animal testing research, stability research, etc.

When applying for registration or filing, non-clinical evidence generated from research and development activities, including a summary of non-clinical research reports, research protocols, and research reports, shall be submitted.

Article 29 The functional and safety indicators and methods determined in the course of non-clinical research of medical devices shall be compatible with the expected use 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 30 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 31 The products used for inspection shall be able to represent the safety and effectiveness of the products applied for registration or filing, and their production shall comply with the relevant requirements of the Good Manufacturing Standards for Medical Devices.

Article 32 The medical device product 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.

Section 2 Clinical evaluation

Article 33 Except for the circumstances provided in Article 34 of these Measures, clinical evaluation shall be conducted for the registration and filing of medical device products.

Clinical evaluation of medical devices refers to the use of scientific and reasonable methods to analyze and evaluate clinical data to confirm the safety and efficacy of medical devices within their applicable scope.

When applying for medical device registration, clinical evaluation materials shall be submitted.

Article 34 In any of the following circumstances, clinical evaluation may be exempted:

(1) The working mechanism is clear, the design is finalized, the production process is mature, and the medical device of the same type has been used clinically for many years without serious adverse events recorded, and the conventional use has not changed;

(2) Other medical devices that can be proved to be safe and effective through non-clinical evaluation.

If it is exempted from clinical evaluation, it may be exempted from submitting clinical evaluation materials.

The list of medical devices exempt from clinical evaluation shall be formulated, adjusted and published by the State Medical Products Administration.

Article 35 Clinical evaluation of medical devices may be carried out based on product characteristics, clinical risks, existing clinical data, etc., through clinical trials, or through analysis and evaluation of clinical literature and clinical data of the same type of medical device, to prove the safety and effectiveness of medical devices.

According to the provisions of the State Medical Products Administration, when conducting clinical evaluation of medical devices, clinical trials should be carried out if the existing clinical literature and clinical data are insufficient to confirm product safety and effectiveness.

The NMPA formulates guidelines for clinical evaluation of medical devices, clarifying the requirements for clinical evaluation through clinical literature and clinical data of medical devices of the same variety, the situation where clinical trials need to be carried out, and the requirements for writing clinical evaluation reports.

Article 36 Where clinical evaluation is conducted through clinical literature and clinical data of the same type of medical device, the clinical evaluation data includes the comparison between the product applied for registration and the medical device of the same variety, the analysis and evaluation of clinical data of the same type of medical device, the scientific evidence and evaluation conclusions when there is a difference between the product applied for registration and the product of the same variety.

If clinical evaluation is carried out through clinical trials, the clinical evaluation data includes the clinical trial protocol, ethics committee opinions, informed consent forms, clinical trial reports, etc.

Article 37 Medical device clinical trials 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 medical device clinical trial quality management specifications. 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 clinical trial medical devices shall comply with the relevant requirements of medical device production quality management specifications.

Article 38 If a Class III medical device is conducting clinical trials with a high risk to the human body, it shall be approved by the State Medical Products Administration.

Clinical trial approval refers to the process in which the State Medical Products Administration conducts a comprehensive analysis of the risk level, clinical trial plan, clinical benefit and risk comparison analysis report, etc. of the medical device to be carried out for clinical trials according to the applicant's application to decide whether to agree to carry out clinical trials.

The Class III medical device catalogue that requires clinical trial approval shall be formulated, adjusted and published by the State Medical Products Administration. Clinical trials of Class III medical devices that require clinical trial approval should be carried out in tertiary medical institutions that meet the requirements.

Article 39 Where clinical trial approval of medical devices is required, the applicant shall submit application materials such as review materials, research materials, clinical data, product manuals, and label samples in accordance with relevant requirements.

Article 40 The Device Evaluation Center of the State Administration shall review the accepted clinical trial applications. The clinical trial application shall be decided or not within 60 days from the date of acceptance of the application, and the applicant shall be notified through the website of the Device Evaluation Center of the State Administration. if the notice is not given within the time limit, it shall be deemed to have been agreed.

Article 41 If the applicant needs to supplement and correct the materials during the review process, the Device Evaluation Center of the State Bureau shall inform all the contents that need to be 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 device evaluation center of the State Bureau will complete the technical review according to the specified time limit.

If the applicant has any objection to the content of the correction notice, he or she may submit written opinions to the Device Evaluation Center of the State Bureau, 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 a decision shall be made to deny approval.

Article 42 The clinical trial sponsor shall report to the drug regulatory department of the province, autonomous region, or municipality where the clinical trial institution is located in accordance with relevant requirements for serious adverse events or other serious safety risks related to clinical trials during clinical trials of medical devices, 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 the medical device or other major safety issues in a large-scale clinical trial in a clinical trial of a medical device, the sponsor shall suspend or terminate the clinical trial of the medical device and report to the drug regulatory department 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 The State Medical Products Administration may order the applicant to terminate the clinical trial of a medical device under any of the following circumstances:

(1) False clinical trial application materials;

(2) The latest research has confirmed that there are problems with the ethics and scientificity of the original approved clinical trial;

(3) Other circumstances that should be terminated.

第四十五条医疗器械临床试验应当在批准后3年内实施；医疗器械临床试验申请自批准之日起，3年内未有受试者签署知情同意书的，该医疗器械临床试验许可自行失效。仍需进行临床试验的，应当重新申请。

第四十六条对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段的疾病的医疗器械，经医学观察可能使患者获益，经伦理审查、知情同意后，可以在开展医疗器械临床试验的机构内免费用于其他病情相同的患者，其安全性数据可以用于医疗器械注册申请。

第三节　注册体系核查

第四十七条申请人应当在申请注册时提交与产品研制、生产有关的质量管理体系相关资料，受理注册申请的药品监督管理部门在产品技术审评时认为有必要对质量管理体系进行核查的，应当组织开展质量管理体系核查，并可以根据需要调阅原始资料。

第四十八条境内第三类医疗器械质量管理体系核查，由国家局器械审评中心通知申请人所在地的省、自治区、直辖市药品监督管理部门开展。

境内第二类医疗器械质量管理体系核查，由申请人所在地的省、自治区、直辖市药品监督管理部门组织开展。

第四十九条省、自治区、直辖市药品监督管理部门按照医疗器械生产质量管理规范的要求开展质量管理体系核查，重点对申请人是否按照医疗器械生产质量管理规范的要求建立与产品相适应的质量管理体系，以及与产品研制、生产有关的设计开发、生产管理、质量控制等内容进行核查。

在核查过程中，应当同时对检验用产品和临床试验产品的真实性进行核查，重点查阅设计开发过程相关记录，以及检验用产品和临床试验产品生产过程的相关记录。

提交自检报告的，应当对申请人、备案人或者受托机构研制过程中的检验能力、检验结果等进行重点核查。

Article 50 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 51 When the Device Evaluation Center of the State Bureau conducts technical evaluation of imported Class II and Class III medical devices, it shall notify the Audit and Inspection Center of the State Bureau to carry out verification in accordance with relevant requirements if it considers it necessary to conduct a quality management system verification.

Section 4 Product Registration

Article 52 The applicant shall submit an application for medical device registration after completing the safety and efficacy research supporting the registration of medical devices and preparing to accept the verification of the quality management system, and submit the following registration application materials to the drug administration department through online registration application 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 53 After receiving the application, the drug administration 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.

The drug regulatory department shall issue a notice of acceptance or rejection of the application for medical device registration with the special seal of the administrative organ and the date of acceptance or rejection.

After the application for medical device registration 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 54 If the applicant needs to supplement and correct the materials during the technical review process, the technical review institution shall inform the applicant of all the contents that need to be 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 55 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 process, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the application for medical device registration.

Article 56 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 57 During the review period of the medical device registration application, if the review conclusion is to be made that is not passed, the technical review agency shall inform the applicant of the reasons for the rejection, and the applicant may raise an objection to the technical review agency within 15 days, and the objection content is 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 58 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 shall be approved for registration, issued a medical device registration certificate, and the approved product technical requirements shall 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 59 For the accepted registration application, the drug administration department shall make a decision not to register under any of the following circumstances and inform the applicant:

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

(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 60 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 61 The drug regulatory authorities may make conditional approval decisions for medical devices used for the treatment of rare diseases, seriously life-threatening diseases for which there is no effective treatment, and respond to public health incidents, and specify in the medical device registration certificate the validity period, the research work that needs to be completed after marketing, and the time limit for completion.

Article 62 For conditionally approved medical devices, the registrant shall collect data related to benefits and risks after the medical device is 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 as required within the specified time limit.

Article 63 For conditionally approved medical devices, if the registrant fails to complete the research as required within the time limit or cannot 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 64 For newly developed medical devices that have not yet been included in the classification catalogue, the applicant may directly 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 a person directly applies for registration of a Class III medical device, the State Medical Products Administration shall determine the category according to the degree of risk. If a domestic medical device is determined to be Class II or Class I, the applicant shall be notified to apply for registration or filing with the corresponding drug regulatory department.

Article 65 If the management category of a registered medical device is adjusted from a high category to a low category, the medical device registration certificate shall continue to be valid during the validity period. If the validity period needs to be renewed after the expiration of the validity period, it 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 medical device management category 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 66 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.

Article 67 Any patent dispute that arises during the examination process and after approval of a 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 68 For medical devices that meet the following requirements, the applicant may apply for the application of the innovative product registration procedures:

(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 69 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 70 For medical device registration applications that apply to the registration procedures for 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 medical devices included in the innovative product registration procedure, the Device Evaluation Center of the State Administration 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 71 For medical devices included in the innovative product registration procedure, if the applicant voluntarily requests termination or the NMPA finds that it no longer meets the requirements of the innovative product registration procedures, the NMPA shall terminate the innovative product registration procedures of the relevant products and inform the applicant

Article 72 For medical devices included in the innovative product registration procedures, if the applicant fails to apply for registration within the specified time limit, the innovative product registration procedures shall no longer apply

Section 2 Priority Registration Procedures

Article 73 Medical devices that meet one of the following circumstances may apply for priority registration procedures:

(1) Medical devices that diagnose or treat rare diseases or malignant tumors and have obvious clinical advantages, diagnose or treat endemic and frequent diseases of the elderly and for which there are currently no effective diagnosis or treatment methods, are exclusively for children and have obvious clinical advantages, or are urgently needed clinically and there is no product 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 74 When applying for priority registration procedures, the applicant shall submit an application to the State Medical Products Administration for the application of priority registration procedures when submitting an application for medical device registration. In the case of Article 73, 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 situation of Article 73, item 2, it shall be reviewed by the Device Evaluation Center of the State Administration, and if it is met, it shall be included in the priority registration procedure; if it falls under the situation of Article 73, the National Medical Products Administration shall listen to opinions extensively and organize expert demonstration to determine whether to include it in the priority registration procedure

Article 75 The State Medical Products Administration shall give priority to review and approve the medical device registration application included in the priority registration procedure, and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall give priority to verifying the quality management system of medical device registration.

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 76 The State Medical Products Administration may implement emergency registration in accordance with the law for medical devices that are required for emergency response to public health emergencies and are not yet marketed in our country, or that are already on the market in our country but cannot meet the needs of emergency response to public health emergencies.

Article 77 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 78 The State Medical Products Administration shall handle the application for medical device registration for emergency registration in accordance with the requirements of unified command, early intervention, on-site review, and scientific approval, and carry out medical device product inspection, system verification, and technical review in parallel.

Chapter 5 Change of Registration and Renewal of Registration

Section 1 Change of registration

Article 79 The registrant shall take the initiative to carry out post-marketing research on medical devices, further confirm the safety, efficacy, and quality controllability of medical devices, and strengthen the continuous management of listed medical devices.

If the design, raw materials, production process, scope of application, and usage methods of registered Class II and Class III medical device products undergo substantial changes, which may affect the safety and effectiveness of the medical device, 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, model, specification, structure and composition, scope of application, product technical requirements, and production address of imported medical devices 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 domestic medical device production address is changed, the registrant shall file the record after handling the corresponding change of 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 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) The new mandatory standards for medical devices are issued and implemented, and the medical devices applying for renewal of registration cannot meet the new requirements;

(3) Conditionally approved medical devices 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 applications for change and renewal of registration of medical devices if not provided for in this Chapter

Chapter VI Medical Device Filing

Article 86 Before the production of Class I medical devices, product filing shall be carried out

Article 87 For medical device filing, the filer shall submit the filing materials to the drug administration department in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices and obtain the filing number

Article 88 For medical devices that have been recorded, if there is a change in the content of the filing information form and the technical requirements of the filed product, the filer shall change the filing to the original filing department and submit an explanation of the change and relevant documents. The drug regulatory department shall publish the change in the filing information

Article 89 Where the registered medical device management category is adjusted to Class II or Class III medical devices, it shall apply for registration 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 medical device registration. The time limit for 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 medical device registration application and clinical trial application, the drug regulatory department shall transfer the application materials to the technical review agency within 3 days from the date of acceptance. The requirements for accepting clinical trial applications shall apply to Article 53 of these Measures

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

(1) The time limit for technical review of medical device clinical trial applications is 60 days, and the time limit for technical review after supplementing and correcting the application materials is 40 days;

(2) The time limit for technical review of applications for registration, change of registration, and renewal of registration of Class II medical devices is 60 days, and the time limit for technical review after supplementary and corrected application materials is 60 days;

(3) The time limit for technical review of registration applications, application for change of registration, and renewal of registration for Class III medical devices is 90 days, and the time limit for technical review after supplementing and correcting application materials is 60 days

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

(1) The Device Evaluation Center of the State Administration shall notify the relevant provinces, autonomous regions, and municipalities directly under the Central Government to initiate verification within 10 days after accepting the medical device registration application;

(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 relevant administrative licenses within 10 days from the date of making the medical device registration approval decision.

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 when external expert consultation, expert consultation meetings, and joint review of drug-device combination products with drug evaluation agencies are required;

(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 department shall strengthen supervision and inspection of medical device development activities, and when necessary, may conduct extended inspections of units and individuals providing products or services for medical device development.

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 medical device 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 If the drug regulatory department fails to promptly discover the systemic and regional risks of medical device registration and management within its administrative region, or fails to eliminate the systemic and regional hidden dangers of medical device registration and management in 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 79 of these Measures are violated by failing to file the changes as required, they shall be ordered to make corrections 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 Those who carry out clinical trials of medical devices that fail to comply with the clinical trial quality management norms 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 institution fails to perform its duties in accordance with the provisions of these Measures, resulting in major mistakes in the evaluation 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 In principle, the registration or filing unit of medical devices shall be based on the technical principle, structural composition, performance indicators and scope of application of the product.

Article 112 Approved medical devices refer to medical devices that are consistent with the limits of the medical device registration certificate and its annexes and are produced within the validity period of the medical device registration certificate.

Article 113 The combined components specified in the "structure and composition" column of the medical device registration certificate may be sold separately if they are used for the purpose of replacing consumables, after-sales service, maintenance, etc.

Article 114 The applicant may quote the registered medical device master file with the authorization of the owner of the medical device master file when applying for medical device product registration, change registration, or clinical trial approval. The working procedures related to the registration of the master file of medical devices are separately stipulated.

Article 115 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 medical devices, imported Class II and Class III medical devices are "country";

Class II medical devices in China are the abbreviations 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" applies to domestic medical devices;

The word "enter" is applicable to imported medical devices;

The word "Xu" applies to medical devices in Hong Kong, Macau, and Taiwan;

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

×4 is the product management category;

××5 is the product classification code;

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

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

Article 116 The filing number of Class I medical devices is arranged as follows:

×1 Equipment ×××× 2××××3. Where:

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

imported Class I medical devices are the word "country";

The first class of medical devices in China is 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 it 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 year of filing;

××××3 is the record serial number.

Article 117 The electronic documents of medical device registration certificates and registration change documents prepared by the drug administration department shall have the same legal effect as paper documents.

Article 118 According to the needs of the work, the State Medical Products Administration may entrust the drug administration departments of provinces, autonomous regions, and municipalities directly under the Central Government, technical institutions, and social organizations to undertake relevant specific work in accordance with the law.

Article 119 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 medical devices within their administrative regions, and report them to the State Medical Products Administration for the record.

Article 120 The registration and charging standards of medical device products shall be implemented in accordance with the relevant provisions of the finance and price authorities of the State Council.

Article 121 The Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents shall apply to the registration and filing of in vitro diagnostic reagents in accordance with the management of medical devices.

Article 122 The relevant provisions on the supervision and administration of customized medical devices shall be formulated separately by the State Medical Products Administration.

The relevant regulations on the registration and management of drug-device combination products shall be formulated separately by the State Medical Products Administration.

The relevant regulations on the emergency use of medical devices shall be formulated separately by the State Medical Products Administration in conjunction with relevant departments.

Article 123 The registration and filing of medical devices in Hong Kong, Macao and Taiwan shall be handled with reference to imported medical devices.