Revision and adjustment of medical device quality certification registration conditions and application material requirements

On August 9, 2004, the State Food and Drug Administration issued the No. 16 Bureau Order "Administrative Measures for Medical Device Registration", which came into force on the date of promulgation. The "Administrative Measures for Medical Device Registration" issued by the former State Drug Administration on April 5, 2000 shall be repealed at the same time. In order to implement medical device regulations in the process of medical device quality certification and ensure that CMD certification meets the requirements of medical device regulations, CMD will also revise and adjust medical devices according to the content and requirements of the newly released "Medical Device Registration Management Measures". The registration conditions for quality management system certification and the requirements for application materials, and the registration conditions for medical device product certification and requirements for application materials are hereby announced as follows:

Application for quality management system certification registration conditions:

1) The applicant organization should hold a legal person business license or documents proving its legal status.

2) Has obtained a production license or other qualification certificates (when required by national or departmental regulations);

3) The products covered by the quality management system applying for certification shall conform to relevant national standards, industry standards or registered product standards (enterprise standards), and the products shall be finalized and produced in batches.

4) The applicant organization should establish a management system that meets the certification standards to be applied for, and should also meet the requirements of the YY/T 0287 standard for medical device production and operation enterprises. For enterprises producing Class III medical devices, the running time of the quality management system should not be less than 6 For enterprises that produce and operate other products, the quality management system shall run for no less than 3 months. At least one comprehensive internal audit and one management review have been conducted.

5) Within one year before the application for certification, the products of the applicant organization have no major customer complaints or quality accidents.