1, the use area of business premises shall not be less than 40 square meters, and the use area of branches shall not be less than 25 square meters (except for trans-regional and municipal); Operating hearing AIDS, the use area of the business premises is not less than 25 square meters; Contact lenses and nursing solutions are sold, and the use area of the business premises shall not be less than 10 square meter.
2, warehouse use area of not less than 30 square meters; To operate disposable sterile medical devices, warehouses should be located in the same building, and the use area should not be less than 200 square meters.
3. The quality management personnel and the person in charge of the quality organization shall have a nationally recognized product-related major, college degree or above, or intermediate or above technical titles of related majors. When operating disposable sterile medical devices, there should be more than one internal auditor with the qualification of internal auditor of medical device quality management system.
Medical device business license handling process
The first stage: application acceptance: the drug supervision department examines whether the application materials meet the basic requirements and decides whether to accept the application; (The application needs to fill in nearly 100 documents. If applicants find any problems with the documents, they need to return them for revision. If there is a major discrepancy, you will be arrested. )
The second stage: on-site audit: the drug supervision department will assign one or three auditors to the enterprise site for audit. The audit method is on-site inquiry and on-site inspection, which truthfully records the audit information and gives the audit conclusion. Do not meet the requirements, you can ask the enterprise to carry out rectification until the rectification meets the requirements. If the rectification still does not meet the requirements, a notice of disapproval shall be given; The purpose of audit is to audit the legality, legitimacy and authenticity of the business premises of the enterprise. If it is found that it does not comply with laws, regulations and rules, the audit conclusion will directly affect whether the enterprise passes the audit and ultimately affect whether the enterprise can obtain the business license qualification. )
The third stage: review, publicity and certification: the leaders of the drug supervision department examine and approve the relevant materials and decide whether to grant the business license; If it passes the examination, the relevant information of the enterprise will be publicized on the relevant website, and if there is no objection, the enterprise will be notified to obtain the medical device business license.
What are the requirements for applying for Class II and Class III medical device business licenses?
Application conditions:
A, with quality management institutions or full-time quality management personnel. Quality management personnel should have relevant professional qualifications or titles stipulated by the state;
2. It has a relatively independent business place, which is suitable for the business scale and business model;
(3) Having storage conditions suitable for the business scale and scope, including storage facilities and equipment that meet the requirements of medical device characteristics;
Four, establish and improve the product quality management system, including procurement, incoming inspection, warehousing, outbound review, quality tracking system and adverse event reporting system;
Five, have the technical training and after-sales service ability to adapt to the medical device products, or provide technical support by a third party.