How to apply for medical device business license? I believe that many people are confused about this, there is no clear and unambiguous concept. Dahui Tang experts for you to explain how to apply for a medical device license it!
One, the declaration of information:
1, fill out the "medical device business license" application form in three copies (copies are invalid);
2, an application report;
3, the enterprise self-check summary (against the "Hubei Province, medical equipment business qualification recognition of the implementation of the rules" and "Hubei Province, medical device business acceptance criteria" requirements) 1 copy
4, enterprise (company) constitution and the latest capital verification report (renewal of the license to provide corporate balance sheet and profit and loss account) 1 copy;
5, business, warehousing space property rights or rental agreement and a copy of the floor plan; business, warehousing space plan: business, warehousing space to show the length, width (meters), business layout and shelves, location of fire-fighting equipment, the five defense facilities And so on.
6, technology, maintenance personnel list and its diploma, title certificate copies of 1 (stamped with the official seal of the unit); technology, maintenance personnel list: refers to the science and technology, medicine, pharmacy, engineering technicians, required to list the name, gender, age, the last graduated from the school, academic qualifications, specialties, technical titles, company positions, identity card numbers.
7, 1 detailed written preliminary examination and acceptance report from the Municipal Drug Administration;
8, quality responsibility, incoming acceptance, storage and outgoing, expiration date, door-to-door sales, special, imported medical devices, after-sales service, health care, and other management rules and regulations.
9, the business name of the business pre-registration certificate or a copy of the "legal person business license" copy of a copy;
10, on the authenticity of the information provided by the self-assurance statement.
Two, the approval process
1, the Drug Administration on the declaration of complete information and meet the requirements of the approval process before acceptance.
2, the Drug Administration in the acceptance of 15 working days from the date of organization or commissioned by the municipal drug regulatory authorities to apply for on-site acceptance of the enterprise. Acceptance includes: office, business, warehousing, maintenance sites, testing, maintenance equipment and installation and maintenance records, quality system implementation, technical staff on duty, business models and collection and preservation of medical devices, rules and regulations and quality standards of the products operated by the quality standards, medical device product registration certificate.
3, site inspection and acceptance, within 10 working days to fill out the medical device approval form, put forward the first review of the opinion, according to the procedures reported to the Division, the Bureau of leadership approval.
Three, the approval fee
Drug Administration of the enterprise acceptance, issued a business license, collect the cost of work and administrative costs.
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