China’s top administrative authority, the PRC State Council, has issued the new regulation of Supervision and Administration of Medical Devices—or State Council Order Number 739—on February 9, 2021. This order replaces the existing State Council Order Number 680 and takes effect on June 1, 2021.
The following announcements are made on matters relating to the implementation of the new Regulations:
1. Full implementation of the medical device marketing authorization holder (“MAH”) system
Any enterprise or medical device development institution that holds a medical device registration certificate for Class II and Class III or filing notification for Class I medical device shall fulfill the obligations of the medical device MAH in accordance with the provisions of the new Regulations.
2. Management of medical device registration and filing notification
MAH will continue to apply for registration and filing notification according to the existing regulations until the relevant regulations or guidance on registration and filing notification are issued in accordance with the new Regulations. The drug regulatory department shall carry out the registration and filing in accordance with the procedures and time limits stipulated in the present regulations.
3. Medical device clinical evaluation management
MAH shall conduct a clinical evaluation in accordance with the provisions of the new Regulations. Those who meet the exemption conditions from clinical evaluation as stipulated in the new Regulations may exempt the clinical evaluation catalog of medical devices from clinical evaluation may refer to the existing exemption catalog from clinical trials until the relevant documents are published and implemented.
4. Management of Medical device production license
Before the issuance and implementation of the relevant provisions on production licenses according to the new Regulations, MAH shall apply for production licenses, and entrust production in accordance with existing regulations and normative documents.
5. Medical device distribute license and filing management
The MAH who sells the medical device registered or filed at his domicile or production address shall not need to apply for a medical device distribute license but shall meet the prescribed operating conditions; Where Class II and Class III medical devices are stored or sold in other places, they shall apply for a medical device distribute license in accordance with the provisions.
6. Investigation and punishment of illegal acts of medical devices
For medical device violations that occurred before June 1, 2021, the old Regulations apply. However, if they are not considered illegal or less severely punished under the new Regulations, the new Regulations shall apply. If the offense occurs after 1 June 2021, the new Regulations shall apply.