Medical device license process:
1, the operator of the business enterprise license application form with medical devices, qualification certificates, business license or business name pre-approval of a copy of the documents to the municipal people's government of the location to apply for a license;
2, the staff to accept the information and 30 working days for review, if necessary, the organization of verification;
3, in line with the conditions specified, and issued to the medical device license; do not meet the conditions specified, not permitted and a written explanation of the reasons.
Engaged in the production of medical devices, should have the following conditions:
1, with the production of medical devices and production sites, environmental conditions, production equipment and professional and technical personnel;
2, the production of medical devices to carry out quality inspection of the institution or full-time inspectors and inspection equipment;
3, to ensure that the medical device Quality management system;
4, with the production of medical devices compatible with the after-sales service capabilities;
5, product development, production process documentation requirements.
Medical device license for the required materials:
1, relevant medical graduates of college (including college) diploma product quality supervision and testing personnel (one of the quality testing responsible);
2, quality supervision and testing personnel ID card and a copy of the diploma, work resume; (Food and Drug Administration teacher to come over to the site to verify the interviews) Need to provide the original ID card and diploma of the relevant testing personnel, and in person);
3, the sale of medical devices each other manufacturer's company business license, medical device manufacturer's license;
4, the sale of medical devices each other manufacturer's medical device registration certificate, medical device registration form;
5, the sale of medical devices each other Manufacturer of commissioned sales authorization.
Legal basis: "supervision and management of medical devices regulations" Article 36
Medical devices need to be regularly checked, inspection, calibration, maintenance, maintenance of medical devices, should be in accordance with the requirements of the product specification for inspection, inspection, calibration, maintenance, maintenance and be recorded in a timely manner to analyze and evaluate. Ensure that medical devices are in good condition, to ensure the use of quality; the use of large-scale medical devices for a long period of time, should be used to establish the use of files, records of its use, maintenance, transfer, the actual use of time and other matters. Record retention period shall not be less than 5 years after the termination of the medical device specified period of use.