What are the specific procedures for registering medical device products?

Medical device products are divided into three levels: Class I, Class II, and Class III. According to relevant national regulations on medical device products, there are certain standards for devices involving the human body. The process of formulating an audit requires approval at various levels, which can be relatively complex. Today, let's standardize the process of registering medical device products and popularize some knowledge about this aspect.

1. Define medical device products and determine which type of medical device products they actually belong to.

According to the risk management of medical devices by the State Food and Drug Administration, medical devices are classified into categories I, II, and III for supervision.

2. Test the product.

For Class I medical device products, a self test report can be provided. For Class I products that are not capable of testing themselves, a testing agency should be entrusted to test them. 2、 Class III and III medical device products need to be entrusted to a nationally recognized testing agency for testing, and the testing agency will issue a pre evaluation and testing report to the sponsor. The production of registered test samples should comply with the relevant requirements of the medical device quality management system. Clinical trials or applications for registration can only be conducted if the registered test samples are qualified.

3. Conduct clinical trials.

Class I medical device products do not need to undergo clinical trials, while Class II and III medical device products need to undergo clinical trials if they are not included in the national medical device exemption catalog or cannot obtain clinical evaluation data through comparison of information obtained from similar products.

4. The applicant shall submit application materials to the food and drug supervision and administration department in accordance with relevant requirements.

The food and drug regulatory department that accepts the registration application shall, within 3 working days from the date of acceptance, transmit the application materials to the technical review institution, which shall complete the technical review of the registration of Class II medical devices within 60 working days and the technical review of the registration of Class III medical devices within 90 working days.

5. The food and drug regulatory department that accepts the registration application shall make a decision within 20 working days after the completion of the technical review.

For those that meet the safety and effectiveness requirements, registration is granted, and a medical device registration certificate is issued within 10 working days from the date of making the approval decision. The approved product technical requirements are issued to the applicant in the form of an attachment. "If the applicant refuses to register, he/she shall explain the reasons in writing, and at the same time inform the applicant of his/her right to apply for review, apply for administrative reconsideration according to law, or institute administrative litigation.".

In the medical device product industry, the approval process cycle is relatively long, and the approval requires a lot of relevant documents. However, once passed, it is undoubtedly not a great good thing for enterprises.