On August 26, 2021, the SAMR (State Administration for Market Regulation) announced (No.47-2021) the Administrative Measures for the Registration and Filing of Medical Devices and (No.48-2021) the Administrative Measures for the Registration and Filing of IVDs.
These regulations support and further implement Order 739 framework for medical device and IVD regulation in China.
- There is no longer a guaranteed time to obtain the results of application approvals for medical devices and IVDs. If the application is rejected, the time limit for applicants to file for an appeal is shortened from 20 working days to 15 working days.
- On September 18, 2021, the NMPA published (No.70-2021) the clinical trial exemption list for IVD reagents in accordance with Order 48, and will come into force on October 1, 2021. The exemption list covers up to 423 IVD reagents. See our previous news for more.
- A new chapter was added in both Order 47 and 48 for special registration procedures covering the scope, procedures, and supporting policies of emergency approval, innovation approval and priority review of medical devices and IVDs while conditional approval was mentioned in the chapter for product registrations.
- For innovative devices that have not been listed in its country of origin, the relevant documents for submission are no longer required, in order to shorten the turnaround time for the products to be listed in China as soon as possible. This confirms the top-level law Order 739 emphasis on innovative devices.
- The requirements for the China test reports of class II and class III medical devices and IVDs have now been adjusted to cover self-inspection reports. There is a separate self-test regulation which provides more detail but is still to be finalized.
- Clinical evaluation information can now be exempted for the dossier submission of medical devices and IVDs if one of the following case scenarios has been met:
- A predicate device has been listed in the market for many years without any serious adverse events or change in its intended use while the working mechanism is clear, and the design and production process is mature.
- Other non-clinical evaluation information that proves the medical device is safe and effective
- The responsibilities of applicants now cover the strengthening of the full product lifecycle management and ensuring the safety, effectiveness and quality control during the development, production, operation, and using stage of medical device or IVD products.
- The unique identification system-related information for medical devices and IVDs should now be submitted to ensure the data is true, accurate and traceable.
- The fine for failing to file for the changed information as required has increased from a maximum of 10,000RMB to between the range of 10,000RMB and 30,000RMB.
- The new arrangement of the medical device registration number, and the filing form, management category and classification code have been removed.
Both administrative measures will become effective from October 1, 2021 onwards, and will replace and abolish the previous 2014 versions.
By Dora Yang, Chelsey Shao and Jacky Li. Contact Cisema if you would like to learn more.