1, the establishment of medical device reporting system. Provide annual reports, production product variety reports, production conditions change reports and re-production reports in four forms of reports, so that the supervisory authority to grasp the production status of enterprises, targeted regulatory measures;
2, further improve the supervision and inspection methods and methods. Clear supervision and inspection, key inspection, tracking inspection, cause inspection and special inspection and other forms of supervision and inspection, and cause inspection and tracking inspection of the content and methods to make specific provisions;
3, refinement of the clear information disclosure and responsibility of the interview system. Drug supervision and management departments in accordance with the law and timely disclosure of medical device production licensing, filing, supervision and inspection, administrative penalties and other information, to facilitate public inquiries and accept social supervision. Medical device registrants, filers, commissioned production enterprises on the existence of medical device quality and safety risks, did not take effective measures to eliminate, drug supervision and management departments can be the legal representative of medical device registrants, filers, commissioned production enterprises or the person in charge of the responsibility of the interview;
4, strengthen the medical device production supervision and management of information technology construction work. State Drug Administration to strengthen the supervision and management of medical device production information construction, improve the level of online government services.
Category of medical device reporting system:
1, the implementation of self-examination report system. Medical device registrants, filers, commissioned manufacturers should be annual self-inspection of the operation of the quality management system, in accordance with the requirements of the medical device production quality management system annual self-inspection report preparation guidelines for the preparation of the self-inspection report, and submit the self-inspection report to the seat of the drug supervision and management department by March 31 of the following year;
2, the implementation of the production of product varieties of the reporting system. Medical device manufacturers should report to the drug supervision and management departments of the product varieties produced. Increase the production of product varieties, should be reported to the original production license or production filing department, involving commissioned production, but also should provide the commissioning party, commissioned to produce products, commissioned period of time and other information;
3, the implementation of the production conditions of the change in the reporting system. Medical device registrants, filers, commissioned manufacturers of production conditions change, no longer meet the requirements of the medical device quality management system, should immediately take corrective measures; may affect the safety and effectiveness of medical devices, should immediately stop production activities, and to the original production license or production filing department report;
4, the implementation of the re-production of the reporting system. Medical device manufacturers to stop production for more than one year and no similar products in production, re-production, should be necessary to verify and confirm, and report in writing to the drug supervision and management department. May affect the quality and safety, drug supervision and management departments can organize verification as needed.
In summary, the medical device registrant, the filer shall be responsible for the release of the product to the market, the establishment of product release procedures, clear release criteria, conditions, and review of the medical device production process records and quality inspection results.
Legal basis:
"Supervision and management of medical device production" Article 6
(a) Drug supervision and management departments set up or designated by law, medical device review, inspection, testing, monitoring and evaluation and other professional and technical institutions, in accordance with the division of responsibilities to undertake the relevant technical work for the supervision and management of the production of medical devices to provide technical support;
( (B) the State Drug Administration Food and Drug Administration Audit and Inspection Center to organize the formulation of medical device inspection system and technical documents, to undertake major cause of inspection and overseas inspection, and provinces, autonomous regions and municipalities directly under the Central Medical Device Inspection Agency quality management system for guidance and assessment.