This page gives a summary of the most important in-vitro diagnostic reagent regulations in China, so regulatory professionals who are in charge of global regulatory management and do not speak Chinese can easily follow changes of the regulations. The regulations are available officially in Chinese. Any regulations provided in English are generated by JMedTec.
The summary includes the medical device regulations applying to IVD reagents.
Update History of the Page
Mar/27/2019 Generate the Information Page
Medical Device Law (including IVD)
Provisions for Medical Device Supervision and Administration (State Council Order No. 680), issued on May 4, 2017, (Chinese version)
Provisions for IVD Reagent Registration (NMPA Order No. 4 in 2014), issued on July 30th, 2014 and effective from Oct/01/2014, (Chinese version).
Announcement for IVD Reagent Registration Dossier Requirements and Certificate Template, issued on Sep/05/2014 (Chinese Version).
Announcement for Matters on Class I Medical Device Notification (No. 26 in 2014), issued on May/30/2014, (Chinese version).
Provisions for China Agent of Imported Medical Device (draft), issued on Dec/24/2018, (Chinese version).
Guidelines for Overseas Medical Device Clinical Trial Data Acceptance, issued on Jan/10/2018, (Chinese version).
List of IVD Reagents Exempted from Clinical Trials, (Summarized by JMedTec in Chinese version).
Good Clinical Practice, issued on Mar/01/2016, (Chinese version).
Provisions for Medical Device Adverse Event Monitoring and Re-Evaluation, issued on Aug/13/2018 and effective from Jan/01/2019, (Chinese version)
Provisions for Medical Device Recall, issued on Jan/25/2017 and effective from May/01/2017, (Chinese version).
Classification and Category
Audit and Inspections
Provisions for Drug and Medical Device Unannounced Inspection, issued on Jun/29/2015 and effective from Sep/01/2015, (Chinese version).
Provisions for Drug and Medical Device Overseas Inspection, issued on Dec/26/2018 and effective from Dec/26/2018, (Chinese version).
Provisions for Medical Device Manufacturing, issued on Jul/30/2014 and effective from Oct/01/2014, (Chinese version)
Medical Device Good Manufacturing Practice, issued on Dec/29/2014, (Chinese version)
Appendix of GMP: IVD Reagents, issued on Jul/10/2015, (Chinese version)
Guidelines for a specific device
The NMPA (ex-CFDA) has also published lots of product-specific guidelines for technical review and clinical trials. Please see the List of guidelines summarized by JMedTec