In 2019, NMPA (CFDA) has announced 3 batches of Overseas Inspection Results. A total of 24 foreign manufacturers, including Medtronic, Becton Dickinson, Boston Scientific, B.Brown, Bausch & Lomb and Varian, were required for rectification and recall. In addition, two manufacturers, Biocomposites and Leica Biosystems, were suspended for importation.
For the detailed Overseas Inspection Results, please click HERE.
For RAPS article on China Overseas Inspection, please click HERE.
Two major issues, both resulting in suspension of importation, have been identified in the NMPA notices:
I Inconsistence of registration unit and sales unit
Description: Calcium sulfate and absorbable artificial bone powder are sold in the form of package, but the syringe and water for injection included in the package were not registered with NMPA.
II Change of supplier without modification registration
Company: Leica Biosystems
Description: The supplier of raw materials, Mouse IgG and hydrogen peroxide, for the test kit manufactured by Leica Biosystems, were changed, but the supplier change has not gone through the modification registration with NMPA.
Other 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 effect verification, raw materials mixing, testing standards mismanagement, lack of operating procedures, air filter supplier audits, etc.
On December 28, 2018 NMPA issued the Guideline on Overseas Inspection for Drugs and Medical Devices (link HERE). This new regulation clarifies overseas inspection processes and responsibilities of NMPA and overseas manufacturers. It also specifies that overseas inspection does not only contain the manufacturing site, but also includes the overseas R&D location.
As a qualified legal agent with offices in Beijing and Boston, China Med Device can provide you with trainings on NMPA overseas GMP inspection and conduct mock inspection.
For English version of Guideline on Overseas Inspection, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For recorded webinar on AE and PMS in China, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.