On 13.03.2020, the NMPA announced (No.09-2020) the Administrative Measures for the Sampling Inspection on the Quality of Medical Devices. This is a new measure designed to increase NMPA’s post-market surveillance and applies to all registered medical devices sold in China.
According to the administrative measures, the NMPA focus is on conducting sampling inspections on medical devices in the market including, but not limited to, those medical devices with the following features:
1. with high safety risks and requiring special supervision;
2. involving a high dosage amount, a wide population of users, and a wide range of uses;
3. for which many complaints have been received and public concerns have been raised;
4. where adverse event reporting indicates possible quality issues; or
5. for which product quality is easily affected by the conditions of storage and transportation.
On the contrary, the provincial MPAs will focus their sampling inspection on medical devices including, but not limited to, those medical devices with the following features:
1. where the product has been registered or filed within the relevant provincial administrative area;
2. with relatively high safety risks and not otherwise included in the list of product categories for inspection;
3. listed in the previous year’s sampling inspection plan, but not yet inspected; or
4. for which daily monitoring and adverse event reporting indicates possible quality issues.
The NMPA legal agents are required to fully cooperate throughout the inspection process for imported medical devices. If there is any objection to the inspection results, the application for re-inspection must be submitted within 7 working days after the issued date of the inspection report.