Medical device safety and people's health are closely related to the two methods to strictly implement the "four most stringent" requirements, the implementation of the "supervision and management of medical devices regulations", the full implementation of the medical device registrant filer system, optimize the administrative licensing process, strengthen the supervision and inspection measures, improve supervision and inspection methods
The implementation of the strictest regulatory requirements. Strengthen the supervision and management of medical device registrants, clarify the responsibilities of both registrants and commissioned manufacturers, incorporate the relevant requirements of commissioned production management into the quality management system, and further improve the inspection duties, inspection methods, results of disposal, investigation and evidence collection, and other regulatory requirements for the production of medical devices. Improve the management requirements of sales, transportation, storage and other aspects of the business process, refine the purchase inspection, sales records and other relevant provisions of traceability management, and strengthen the registrant, the filing of the sale of its registration, filing of the quality and safety of medical devices responsibility.
Compacting the main responsibility of medical device production and management enterprises. The establishment of medical device production reporting system, the production of product variety report, production dynamic report, production conditions change report and quality management system operation self-check annual report and other requirements. At the same time, optimize the licensing and filing process, the medical device registrant system under the relevant business license, filing and other requirements for adjustment, the abolition of the permit to submit business license and relevant documents required to further compress the verification and approval time limit, clearly exempted from submitting the application information and exempted from the operation of the filing of the specific circumstances, and at the same time apply for licensing and filing of the application, simplify the submission of materials, such as the procedural requirements.
Compact departmental supervision responsibility. Refinement and improvement of the responsibilities of the regulatory departments at all levels, improve supervision and inspection, key inspection, tracking inspection, cause inspection and special inspection and other forms of supervision and inspection. It clarifies the requirements for the responsibilities of the drug regulatory authorities in the case of inter-provincial entrusted production by the registrant, clarifies the joint and assistance provisions in the areas of inter-regional supervision and inspection, investigation and evidence collection, adds the relevant provisions on extended inspection and joint inspection in the operation link, and improves the management system of overseas inspection as well as the disclosure of information and responsibility interviews.
Strengthening quality and safety risk control. Combined with the supervision of the actual further refinement of the medical device production and management of classification management and risk control, causal inspection requirements. Strengthen the quality and safety risk control, classification of clear production and operation of supervision and inspection of the focus of the medical device registrants, filers and business enterprises specifically to provide transportation, storage services, clear quality responsibility and management requirements. At the same time, clear drug regulatory authorities should be based on supervision and inspection, product sampling, adverse event monitoring, complaints and reports, administrative penalties, etc., and regularly carry out risk consultation and judgment, and do a good job of medical device quality and safety risks and prevention, control and disposal work.
Legal basis:
"Supervision and Management of Medical Device Manufacturing"
Article 18 The medical device manufacturer to change the licensing matters shall, 30 days prior to the change of the original licensing matters, fill out the "Medical Device Manufacturer License (Change) Application Form" (see Annex 3 of these measures), with reference to the provisions of Article IX of these measures, to submit to the original licensing authority involving the change of contents of relevant materials, and submit to the original licensing authority, and then submit to the original licensing authority, and then submit to the original licensing authority, the relevant materials. Relevant materials, to the original licensing authority to apply for "medical device manufacturer license" change registration. The original licensing authority shall, within 15 working days from the date of receipt of the application for change of the enterprise and the change of the application materials, make a decision on whether to grant the change or not to grant the change. Permitted to change, the recovery of the original license, issue a new license, after the change of "medical device manufacturer license" expiration date unchanged. Do not change, should be written reasons, and inform the applicant the right to apply for administrative reconsideration or administrative litigation according to law.
Medical device manufacturers in accordance with the law, "Medical Device Manufacturer License" permit matters change procedures, should be promptly to the administrative department for industry and commerce for changes in business registration.