New Details on Sampling Inspections of Medical Devices

On April 12, the NMPA (National Medical Products Administration) announced (No.45-2021) the inspection plan for medical devices. For foreign manufacturers, this is most relevant for post-market activities and will be useful when manufacturers are notified for sampling inspections by the NMPA.

Highlights

• The inspection work shall be carried out in accordance with the mandatory standards or product technical requirements as indicated in the item list (attached in the NMPA announcement).

• If the medical device manufacturer objects to the inspection results, he can apply for re-inspection within 7 working days from the date of receiving the results. The medical device manufacturer should refer to the list of inspection companies (attached in the NMPA announcement) to apply for re-inspection.

• If the medical device manufacturer objects the test method and test basis and at the same time fails the re-inspection, he can apply for an appeal with the respective MPA within 10 working days from the date of receiving the results. Upon receiving the application, the MPA will investigate and submit a proposal report to the NIFDC (National Institutes for Food and Drug Control).

By Jacky Li. Contact Cisema if you would like to learn more.