China: NMPA releases guidelines on overseas inspections of medical device companies

08-01-2019

China: NMPA releases guidelines on overseas inspections of medical device companies

(Source: RAPS 2019-01-09)

China’s National Medical Products Administration (NMPA) has published guidelines on inspections of overseas medical device manufacturers. NMPA created the guidelines to fulfill a government request to raise the standard of products imported into the country.

China has stepped up its oversight of overseas companies in recent years. In 2016, China identified a record number of foreign companies for inspection. The following year, China’s regulatory agency released a document intended to standardize its approach to the inspection of foreign manufacturing facilities.

Now, NMPA has added a device-focused document to expand beyond its earlier drug site inspection activities. The document clarifies that China’s overseas inspections will target R&D sites, in addition to manufacturing facilities, and covers how NMPA will handle companies that obstruct its activities.

More Information On RAPS

New Article