On October 21, 2021, the Chinese health authority (NMPA) has published a new regulation related to the requirements of Local testing as part of medical devices registration in China: “Regulations on the Administration of Medical Device Registration and Self-inspection”
To encourage the development and speed up the registration process of innovative medical devices in China, the China’s medical device regulatory agency (NMPA) has issued a new regulation allowing foreign manufacturers of medical devices to include self-testing reports in their submissions of registration dossier to NMPA, instead of local testing reports issued in China by accredited laboratories. The new regulation applies to Class II (medium-risk) and Class III devices (high-risk) devices.
However, in order for NMPA to accept the self-testing reports, applicants should comply with the following:
1. Have the Required Testing capabilities
Foreign company (Applicant) should conduct the self-testing in line with the requirements of the quality management system and have the capabilities to perform such tests, in terms of qualified personnel, equipment and environmental, facilities, samples’ management, quality control, and records’ control. They should also ensure that the quality of the self-testing is under control, and they should take responsibility of the content and results of the testing reports.
If applicant conducts specialized testing, such as biological testing, electromagnetic compatibility testing, or biosafety testing, they should perform a risk assessment evaluating the impact of such testing on the environment.
If the applicant outsources the testing to a third party laboratory, they should have in place a quality agreement with the laboratory that defines the responsibilities of both parties.
During NMPA on-site inspection of the applicant’s quality management system, the self-testing capabilities will be verified item by item and results will be recorded in the NMPA inspection report.
2. Have Qualified Personnel to Conduct the testing
Self-testing should be conducted by qualified personnel, trained on the testing methods and authorized to perform such testing. Additionally, people who are performing testing should be full-time employees of the company and dedicated to the products’ testing work.
3. Correct Content of Self-testing Report
The applicant should conduct testing in accordance with the product technical requirements of the products to be registered. The self-testing report should include tests on the entire technical requirements of the product.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.