Medical device product testing methods

Hello, for medical device product testing methods, the applicant or the filing should be prepared to register or record the product technical requirements of medical devices. Class I medical device product technical requirements by the filer for the record submitted to the food and drug supervision and management department. Class II, Class III medical device product technical requirements by the food and drug supervision and management department in the approval of registration to be approved.

Product technical requirements mainly include performance indicators and test methods for finished medical devices, of which performance indicators refer to the functionality of finished products that can be objectively determined, safety indicators and other indicators related to quality control.

Medical devices marketed in China shall comply with the technical requirements of the products approved or filed by registration.

Article XVI of the application for registration of Class II, Class III medical devices shall be registered test. Medical device testing organizations should be based on product technical requirements for the registration of relevant products.

The production of registration test samples should be in line with the relevant requirements of the quality management system for medical devices, registration test qualified before clinical trials or apply for registration.

For the first class of medical devices for the record, the filer can submit the product self-test report.

Article XVII of the application for registration and inspection, the applicant shall provide the inspection agency for registration and inspection of the relevant technical information required, registration and inspection of samples and product technical requirements.

Order XVIII of the medical device testing organizations should have medical device testing qualifications, within the scope of its inspection and testing, and the applicant submitted to the pre-evaluation of product technical requirements. Pre-evaluation of opinions with the registration of test reports issued to the applicant.

Not yet included in the scope of medical device testing organizations to undertake inspection of medical devices, the corresponding registration and approval department designated by the competent inspection agency for testing.

Article 19 of the same registration unit of the product tested should be able to represent the safety and effectiveness of other products within the unit of registration.