(wholesale, retail) license application procedures and materials to be submitted
1, the approval process
Applicant → submit an application to the Municipal Bureau of the window of the form of review of the information → registration of acceptance of compliance with the requirements of the special seal of acceptance → sent to the Municipal Bureau of Medical Devices Section of the substantive audit → organization On-site review (two or more inspection team) → meet the conditions of the application by the municipal leadership to validate and sign the opinion of the second class of medical devices and is a direct fitting nature of the business enterprise by the Municipal Bureau of Medical Devices Division to produce and apply for the "Medical Device Business License" → publicity and results of the approval process → approval of the third class of medical devices sent to the Provincial Government Center of the Provincial Food and Drug Administration window for acceptance.
2, the application report to provide materials
(1) the application report should include:
① proposed to open the enterprise name, economic nature;
② premises area, geographic location;
③ the legal representative of the description;
④ proposed to set up a number of professional and technical personnel, academic qualifications and specialties;
⑤ the scope of products to be operated (according to the "Medical Devices Classification Catalog" to explain, the number must be written to the small);
6 is to increase the scope of medical devices should be attached to the "business license" copy.
(2) a copy of the legal representative's identity card;
(3) industrial and commercial administration department issued a "pre-approval notice of enterprise name" copy;
3, apply for a "medical device license" materials to be submitted
(1) "Anhui Province, two copies of the license application form for medical equipment business enterprises, and at the same time, submit the content of the electronic softcopy consistent with the "application form". Application Form" content consistent with an electronic diskette;
(2) the administrative department for industry and commerce issued by the "pre-approval of the enterprise name notice" or "business license" copy; drug business enterprises operating medical devices should be accompanied by a "drug business license" copy of the original; medical device manufacturers to set up their own product management organization, should be accompanied by a "medical device manufacturer license" copy.
(The medical device manufacturer shall attach the copy of "medical device manufacturer license".
(3) the legal representative of the proposed enterprise's certificate of office and a copy of ID card;
(4) the person in charge of the enterprise, the person in charge of quality management of the documents and biographical information;
(5) all quality management, quality verification, after-sales service, and other professional and technical personnel of the academic qualifications, professional title certificates, copies of ID cards and the original of the contract of employment with the legal entity signed
(6) business address, warehouse address location map and layout plan (indicating the area), proof of property rights or lease contract;
(7) quality management system directory and storage facilities, equipment directory;
(8) business constitution or the corresponding information note;
(9) organization and function set up a box diagram;
(10) the proposed scope of business varieties;
(11) the submitted materials of the authenticity of the self-assurance statement;
(12) other required to provide supporting documents, materials;
(13) apply for a license for Class III medical devices, in addition to providing the above materials, the "application form" should be signed by the local municipal food and drug regulatory bureau to review the above materials proposed Authenticity and completeness of the opinion.
(14) unincorporated enterprises are also required to provide:
① legal person enterprise "business license" copy of the "Medical Device Business License" should be attached to the "license" copy;
② legal person issued by the enterprise written opinion.