The Department of General Affairs of the National Medical Products Administration ("NMPA") has recently enacted and issued the Working Rules for Testing of Medical Devices (Draft for Comment) (the "Draft for Comment") to seek public comments.

The Draft for Comment states that, testing agencies and their staff members shall remain independent from interested parties involved in their work on testing medical devices, and ensure their testing activities are conducted in a scientific and independent manner, and they shall not issue any test reports containing untruthful data or false results. Besides, testing agencies and their staff members are banned from committing certain acts, including "seeking unjustified interests from principals or interested parties". In addition, the Draft for Comment clearly states that, a testing agency shall obtain the corresponding qualification to test medical devices or be designated by the corresponding registration approval authority, before conducting tests within the testing scope, and be competent enough to conduct tests in accordance with currently valid national standards; it also shall have the capacity, as needed, to make a preliminary evaluation of technical requirements of products provided by the principal. Furthermore, the Draft for Comment requires that, conclusions presented in a test report shall be explicit and the testing agency shall be held accountable for any information contained in the test report.

(Source: NMPA)