NMPA (CFDA) published two groups of overseas inspection results on Jan 18 and Jan 30. 17 overseas medical device and IVD manufacturers were cited, including some big players, BD, Boston Scientific, Varian, Deerfield Imaging, etc. Manufacturing facilities were located in the U.S, UK, Germany, Netherlands, France, Japan, South Korea.
For NMPA link of detailed results with observations and penalties, please email info@ChinaMedDevice.com. ChinaMed Device, LLC, a NMPA certified legal agent, can help you prepare NMPA overseas inspection with onsite training.
From November 2017 to February 2018, 24 foreign manufacturers have been found with issues in overseas inspections. The significant issues disclosed by the overseas inspections include internal packaging breakage, incomplete supplier information, improper handling of adverse events, airborne dust particles exceeding the standard, deficiencies in disinfection effecting verification, raw materials mixing, testing standards mismanagement, lack of operating procedures, air filter supplier audits, etc.
On December 28, 2018, NMPA issued Guideline on Overseas Inspection for Drugs and Medical Devices. This new regulation clarifies overseas inspection process and responsibilities of NMPA (CFDA) and overseas manufacturers. It also specifies that overseas inspection includes not only manufacturing sites, but also overseas R&D locations.
For RAPS post on NMPA overseas inspections, please see link Here.
For English version of Guideline on Overseas Inspection, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.