Further Requirements For The Self-testing Of Medical Devices For China Registration

On July 23, 2021, the China NMPA issued the further modified draft guidance on the Self-testing of Medical Devices for China Registration based on comments collected from the public previously. NMPA is now releasing the second draft guidance for public opinions with a deadline for feedback on July 31, 2021.

Regarding the self-testing report, if the overseas group company or its subsidiary has a laboratory approved by the overseas government or by the corresponding laboratory qualification certification body which the overseas government recognizes, the group company or its subsidiary may, upon authorization, carry out self-testing by the corresponding laboratory. The registration applicant shall issue the self-testing report.

Compared with the first draft, several newly items have been added in the second draft:

• Quality Management System

In registration dossier, add quality management system documents related to testing, such as quality manual, procedure documents, etc. Therefore, before carrying out self-testing, manufacturers shall add or modify the system accordingly and form supporting documents.

• Detailed Requirements for Self-testing Capability.

For the quality management system documents, the manufacturer shall prepare corresponding documents meeting requirements of self-testing capability, such as personnel, equipment and environmental facilities, sample and inspection quality control. If there is existing document, those requirements of self-testing capability shall be involved in it. The corresponding records shall be kept continuously to ensure traceability.

• Self-testing Standard Description.

The formulation of testing methods shall conform to the corresponding performance indicators. Priority shall be given to the use of published standard or recognized testing methods. Accordingly, self-testing shall be made on the basis of current Chinese standards and corresponding PTR shall be formed before that.

• Increased Liabilities.

The registration applicant shall, in accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices, strengthen the quality management of the whole life cycle of medical devices, and bear responsibility for the safety and effectiveness of medical devices in the whole process of development, production and testing according to law. The authenticity of self-testing report and third-party test report must be guaranteed, otherwise corresponding penalties will be imposed.