Medical equipment business license expires need to continue, the medical device business enterprises should be in the validity of the expiration of 90 working days to 30 working days before the continuation of the application period. Late application for continuation, no longer accept the continuation of the application.
Two, analyze the details
For the continuation of the medical device license process:
1, the applicant logged on to the medical device enterprise service platform, apply, fill in the information, submit the information to receive the acceptance number;
2, the person to the jurisdiction of the Administrative Licensing Service Center Market and Quality Supervision Bureau window to submit the application materials with the acceptance number, window Staff to receive and verify the application materials, application materials are complete and in accordance with the statutory form, issue a notice of acceptance and inform the applicant needs to site visits;
3, the District Market and Quality Supervision Bureau for review, in the medical device license expires before making a decision on whether or not to grant the continuation of the decision to meet the prescribed conditions, granted the continuation of the extension of the extension of the notification of the applicant to receive a new license, return the original license. Original license.
Three, the medical device manufacturing license renewal conditions
1, hold the enterprise's medical device registration certificate;
2, there is the production of medical devices for quality inspection of institutions or full-time inspectors and inspection equipment; production, quality and technical personnel should have the production of medical devices and the production of professional competence and mastery of the national laws and regulations on the supervision and management of medical devices. National supervision and management of medical devices and related laws, rules and regulations of product quality, technology, quality of the person in charge shall not be concurrently responsible for the production;
3, there is to ensure that the quality of medical devices management system;
4, with the production of medical devices compatible with the after-sales service capabilities;
5, in line with the development of the product, the production process documentation requirements. Requirements;
6, the enterprise should be preserved with the production and operation of medical devices related laws, regulations, rules and relevant technical standards.