Applicants for registration of medical devices and filers should establish a quality management system related to product development and production, and maintain effective operation.
In accordance with the innovative medical device special approval procedures for the approval of the domestic medical device application for registration, samples entrusted to other enterprises, should be entrusted with the corresponding production scope of the medical device manufacturer; does not belong to the innovative medical device special approval procedures for the approval of the domestic medical device application for registration, the samples shall not be entrusted to other enterprises.
The person who handles the registration or filing of medical devices shall have appropriate professional knowledge and be familiar with the laws, regulations, rules and technical requirements for the registration or filing of medical devices. The applicant or the filer to apply for registration or for the record, should follow the basic requirements for the safety and effectiveness of medical devices, to ensure that the development process is standardized, all the data is true, complete and traceable.
Extended information:
Medical device registration requirements stipulate:
1, apply for registration of Class II and Class III medical devices should be registered test. Medical device testing organizations should be based on the product technical requirements of the relevant product registration test.
2, the production of registration test samples should be in line with the relevant requirements of the quality management system of medical devices, registration test qualified before clinical trials or apply for registration. For the record of the first class of medical devices, the filer can submit the product self-test report.
3, medical device testing organizations should have medical device testing qualifications, within the scope of its inspection for testing, and the applicant to submit the product technical requirements for pre-evaluation. Pre-evaluation of the opinion with the registration inspection report issued to the applicant.
Baidu Encyclopedia-Medical Device Registration