Local type testing is a requirement for doing clinical trials and registering devices in China.
In a bid to foster innovation in the development of medical devices without sacrificing safety, China’s medical device regulatory agency announced in October it will permit foreign manufacturers to submit more of their own self-tests.
The new flexibility from the National Medical Products Administration (NMPA) is designed to speed the registration and approval process for some medical devices. The new regulation pertains to Class II devices, considered mid-risk, and to Class III devices, considered high-risk because they are implanted into the human body, used to support or sustain life, etc.
But the new policy includes strict controls on how testing must be conducted in order for products to meet the approval of Chinese regulators, and it strongly increases liability penalties for manufacturers who do not adhere to NMPA criteria. Among other things, equipment, operating procedures, measurement devices, and facilities must meet requirements laid out by NMPA. Maintenance records must be kept in accordance with NMPA requirements, and laboratories must adhere to strict standards as laid out by the agency. Samples to be tested must be meticulously overseen, and records of all evaluations and testing will need to be made available to NMPA authorities upon request.