China’s National Medical Products Administration (NMPA) recently released a draft guideline permitting foreign medical device manufacturers to use accredited overseas labs to conduct product self-testing (type testing) as part of their China medical device registration. The public comment period ends in July.
The guideline is a significant step toward international regulatory harmonization. If a foreign lab is authorized by the applicant and certified by a recognized authority (e.g., ISO/IEC 17025, FDA, or European authorities), the laboratory test data can be utilized in place of local type testing in China, potentially cutting costs and accelerating market access.
The guideline states that self-testing has to be incorporated into the applicant’s quality assurance system and fulfill China’s GMP. There is a chance that the NMPA will conduct audits of the overseas labs to verify their capabilities, although it is more likely that only paper audits will be adequate for well-documented products and accredited laboratories.
Foreign companies should be aware that while foreign testing is now officially recognized, in practice, it can still be simpler and quicker to do type testing in China. Generally, domestic labs tend to face few barriers, and NMPA audits are more straightforward for local testing facilities.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.