In order to strengthen the management of medical device registration, regulate the self-testing conducted by applicants, clarify the content and format of self-testing reports for the registration application dossier, and ensure that the self-testing for medical device registration is carried out in an orderly manner, NMPA is working on a new Regulation on self-testing for medical device registration. The draft provisions are established as follows:
1. Basic Principles:
The applicant shall ensure the test equipment and facilities are appropriate to the product inspection, according to the requirements of the quality management system. It shall have the appropriate quality inspection institution or full-time inspection personnel. And the applicant should be responsible for the self-testing report.
2. Self-testing reporting requirements:
a) A self-testing report shall be a full testing report based on the product technical requirements
b) The self-testing report shall be accurate in conclusion and shall not be altered.
c) The model, specification/packaging specification specified in the self-testing report could represent other models in the different registration units. It is required to elaborate on the typicality of the tested models, and analyze the differences between the models.
If the applicant does not have the inspection ability of some items according to the product technical requirements, the relevant tests may be entrusted to qualify medical device inspection institutions; The applicant shall evaluate the qualification and testing ability of the subcontractors. All the evaluation records and reports shall be documented in the quality management system. The applicant shall ensure that the samples tested by the manufacturer and samples tested by the subcontractor are consistent.
4. Requirements for the submission dossier:
The self-testing report shall also be accompanied by a statement with the appropriate self-testing capability and a self-assurance statement of the report’s authenticity. If the laboratory or inspection institution is overseas, the applicant shall submit a qualification certificate by the overseas government or by the certification body accredited by the government.
5. On-site inspection requirements:
For those who submit self- testing reports, on-site inspection of the quality management system shall be carried out in accordance with the requirements of the on-site inspection guidelines for the registration of medical devices. It should also focus on inspection records, capabilities of quality control, inspectors' operating skills, qualification requirements for inspector, facilities, environment, and testing equipment.
Regulation on self-examination of medical device registration (Draft for Comments)