In-house and Qualified Third-party Test Reports Will be Accepted for Medical Device Registration

Background

Type testing – a proof that a sample device complies with mandatory norms and the manufacturer’s own specifications – is a key element of the medical device registration procedure in China. Up until now, only test reports from test institutes under the National Medical Products Administration (NMPA) were accepted for registration. Lack of resources at these test institutes led to very long, unpredictable waiting times, especially for new innovative medical devices. To eradicate this bottleneck in medical device registration, the NMPA has formulated an amendment to the Provisions (“Provisions”) on Medical Device Regulation that, once adopted by the National People’s Congress, will accept in-house test reports from the manufacturer and reports from third-party test institutes.

Result

The NMPA has proposed a very positive amendment to the Provisions that will allow faster access by Chinese patients to new and innovative medical devices. The Chamber expects the final version of the amendment to be promulgated by the National People’s Congress later this year.

Impact