How to apply for a medical device business license? I believe many people are confused about this and have no clear concept. Dahuitang experts will carefully explain how to apply for a medical device business license!
1. Application materials:
1. Fill in the Application Form for Medical Device Business License in triplicate (the copy is invalid);
2. 1 application report;
3. Self-inspection summary of enterprises (65,438+0 copies according to the requirements of the Detailed Rules for the Implementation of Qualification Identification of Medical Device Operating Enterprises in Hubei Province and the Acceptance Standards for Medical Device Operating Enterprises in Hubei Province);
4. Articles of Association of the enterprise (company) and the latest capital verification report (providing the balance sheet and profit and loss statement of the replacement enterprise) each 1 copy;
5. 1 Certificate of property right or copy of lease agreement and floor plan of the business and storage place; Floor plan of business and storage place: The business and storage place shall be marked with the length, width (meter), business layout, shelf placement, fire fighting equipment location, five prevention facilities, etc.
6. List of technical and maintenance personnel and copies of their graduation certificates and professional title certificates, each 1 copy (stamped with the official seal of the unit); List of technicians and maintenance personnel: refers to technicians in science, engineering, medicine and engineering. Name, gender, age, graduation institution, education background, major, technical title, company position and ID number are required.
71copy of the detailed written preliminary acceptance report of the Municipal Drug Administration;
8, quality responsibility, warehousing acceptance, storage and delivery, validity, store sales, special and imported medical devices, after-sales service, medical and health management and other rules and regulations.
9. 1 name of enterprise: copy of industrial and commercial pre-registration certificate or business license of legal person;
10, self-assurance statement on the authenticity of the information provided.
Second, the approval process
1, the application materials are complete and meet the requirements of the examination and approval procedures, and the Food and Drug Administration can accept the application.
2. The drug administration shall, within 15 working days from the date of acceptance, organize relevant personnel or entrust the municipal drug supervision department to conduct on-site acceptance of the bidding enterprises. The acceptance contents include: office, business, storage and maintenance places, inspection and maintenance equipment and installation and maintenance records, implementation of quality system, on-the-job situation of technicians, laws and regulations on business varieties and collection and preservation of medical devices, quality standards for business varieties, and registration certificates for medical devices.
3, on-site acceptance, 10 working days to fill in the "medical device approval form", put forward the preliminary examination opinions, according to the procedure submitted to the department, bureau leaders for approval.
Third, the examination and approval fee.
The US Food and Drug Administration will issue a business license after the enterprise is qualified, and collect production fees and management fees.
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