On January 18, 2019, NMPA (CFDA) announced the first batch of Overseas Inspection Results in 2019. Five foreign manufacturers, including BD and Rayner, were cited with 24 observations. Grace Palma, CEO of China Med Device, is interviewed by Zachary Brennan, Managing Editor of Regulatory Focus, from Regulatory Affairs Professionals Society (RAPS).
China’s NMPA Cites Overseas Device, IVD Companies
Posted 01 February 2019 | By
China’s National Medical Products Administration (NMPA) published overseas inspection results in late January, highlighting 17 overseas medical device and IVD manufacturers that were cited, including BD and Boston Scientific.
Since November 2017, when NMPA began to publish overseas inspection results, a total of 41 manufacturers have been cited, according to ChinaMed Device, LLC, which is a medical device and IVD consulting firm based in Boston, and is a certified NMPA legal agent.
NMPA has inspected Varian, Deerfield Imaging and other manufacturing facilities in the US, UK, Germany, Netherlands, France, Japan and South Korea.
“The significant issues disclosed by the NMPA during the overseas inspections include: internal packaging breakage, incomplete supplier information, improper handling of adverse events, airborne dust particles exceeding the standard, deficiencies in disinfection effect verification, raw materials mixing, testing standards mismanagement, lack of operating procedures, air filter supplier audits, etc.,” ChinaMed Device said.
As far as the evaluations, NMPA can signify that companies “meet the requirements,” “meet the requirements after rectification” or “do not meet the requirements.”
If classified as “does not meet the requirements,” ChinaMed Device said the penalties include: rectification within a time limit, warning letters, suspension of importation, suspension of sales, recall and cancellation of importation and approval certificates.
Overseas Inspection Guideline
Last December, NMPA issued a final guideline, “Administrative Regulations of Drug and Medical Device Overseas Inspection,” which explains how overseas manufacturers, after receiving an “Announcement of Overseas Inspection,” shall submit two documents in 20 working days to NMPA: a “Letter of Authorization” and “Basic Information Table of Overseas Inspecting Products,” and then submit main documents on the inspecting site and other necessary materials within 40 working days.
Also within 40 business days of receiving inspection feedback, manufacturers are expected to submit the corrective outcome.
According to ChinaMed Device, there are several new regulations that overseas enterprises need to consider:
- Overseas inspection does not only mean manufacturing site, but also can include overseas R&D locations.
- NMPA can acquire and inspect “relevant technical files with crypto-security” and include them in the inspection files.
- “The manufacturers should keep normal condition and cooperate to inspect relevant equipment and sites.”
- If necessary, NMPA can sample and seal products, and manufacturers shall ensure the package and transportation condition of the sample cannot affect its quality.