October 1, 2021
The National Medical Products Administration (NMPA), China’s medical device market regulator, has revealed plans to set up a technical division focused on clinical evaluation of medical devices, as well as issued new guidelines for animal testing studies related to medical devices.
New authority for medical device clinical evaluations
First, the NMPA has announced (link in Chinese) the establishment of a national technical authority to address medical device as well as in vitro diagnostic (IVD) clinical evaluations. The new unit will oversee development and maintenance of general as well as special standards pertaining to clinical evaluations, including the following components:
- Clinical trial quality management
- Clinical data management and data exchange
- Real-world research requirements
- Clinical data processing
The NMPA announcement also identifies several expert groups that will help steer the new authority; these groups will consist of universities, hospitals and healthcare provider networks, life sciences and medical device company representatives, and regulatory agencies.
Animal testing studies for medical devices
Second, Chinese regulators have published new guidelines (link in Chinese) pertaining to animal testing studies and investigations for medical device registrants.
The NMPA has issued the guidelines in two parts. Part 1 covers decision-making principles to help determine whether animal testing for a device is warranted as well as how to reduce the number of such studies when possible. Part 2 covers test design and quality assurance considerations.