1, medical device registration certificate is valid for 5 years. The expiration of the validity of the need to continue the registration, should be valid for six months before the expiration of the original registration department to apply for renewal of registration. In addition to the third paragraph of this article, the continuation of the application for registration of food and drug supervision and management departments should be in the medical device registration certificate before the expiry of the validity of the decision to grant the continuation. If no decision is made after the expiration date, the renewal shall be deemed to be granted.
2, the legal basis: "Supervision and Administration of Medical Devices Regulations" Article 57
Medical device testing organizations accreditation work in accordance with the relevant provisions of the implementation of the unified management. Certification and Accreditation Administration of the State Council in conjunction with the Food and Drug Administration of the State Council recognized the inspection agency, before the implementation of medical device testing.
Food and drug supervision and management departments in the enforcement of medical devices need to test, should be entrusted to qualified medical device testing organizations, and pay the relevant fees.
The parties have objections to the test conclusions, you can receive the test conclusions within seven working days from the date of selection of qualified medical device testing organizations for re-examination. Undertake re-inspection of medical equipment testing organizations should be in the State Council food and drug supervision and management department within the time specified in the re-inspection conclusion. Retest conclusions for the final test conclusions.
Two, for the record of Class II medical device materials need:
1, business license and copy;
2, legal representative, enterprise responsible person, quality responsible person's identity, education or title certificate;
3, list of professional and technical personnel and professional and technical personnel's identity card, proof of education, title certificate;
4, organizational structure and departmental settings; business scope, business mode description;
5, business premises, warehouse address location map, floor plan, documents proving ownership of the house or by the housing lease issued by the housing lease certificate copy. Warehousing commissioned by the third-party logistics of medical devices, provide the commissioning contract;
6, business quality management system, work procedures and other documents directory. Including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents;
7, business facilities, equipment directory;
8, the enterprise has been installed in the computer information management system basic information and functional description, print the information management system home page.