First of all, we need to know that the state for medical devices in accordance with the degree of risk, is divided into three categories of management, the following is a detailed description of these three categories:
The first category: is a low degree of risk, the implementation of routine management can ensure the safety of medical devices, effective.
The second category: is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
The third category: is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
The medical masks and protective clothing that were a big hit during the new Crown pneumonia outbreak belong to the second class of medical devices.
In accordance with the "supervision and management of the production of medical devices", the opening of the second class, the third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for a production license. So how to apply for the production license of Class II and Class III medical devices? What conditions need to be met? What information to submit?
Medical device license application materials:
Apply for the first class of medical devices business enterprise filing procedures and material requirements:
The operation of the first class of medical devices must be handled for the filing of stamped procedures. Filing procedures and reporting materials:
One, business (including part-time) enterprises to apply, fill out the "medical device business enterprise filing form" a type of three (copies are invalid), signed by the legal representative and the enterprise seal;
Two, provide materials
1, business name business pre-registration certificate or a copy of the industrial and commercial business license copy of a copy;
2, a copy of the title certificate or certificate of graduation of technical personnel;
3, all varieties of medical devices operated by a copy of the product registration certificate;
4, the basic situation of the enterprise materials (fill in the filing form), including: the economic nature of the enterprise, the scope of business operations, medical equipment varieties, technicians, medical equipment quality assurance and after-sales service measures;
Third, the enterprise declaration materials must be true, all materials uniformly with A4 specification paper, fill in the form of neat font, with standardized simplified Chinese characters, all the declaration materials should be stamped with the official seal of the enterprise.
Four, complete information before acceptance, acceptance of 30 working days for the record seal.
Application for medical device business license (second and third class) issued:
1) "Medical Device Business License Application Form";
2) business administration issued by the "pre-approval of the enterprise name notification" or "business license" original and copies;
3) quality management personnel ID card, education or professional title Proof of the original and a copy of the certificate and personal resume;
4) organizational structure and functions;
5) registered address (the business address of the enterprise registration) and the warehouse address of the geographic location of the map and the floor plan (indicating the area) and the proof of ownership of the house (or lease agreement) original and a copy of the above materials;
Enterprises take a centralized warehouse to store the products, you need to submit Enterprise legal person "business license", "medical device business license" and its corporate centralized warehouse instructions (can no longer be submitted to the warehouse of the proof of ownership of the house or lease agreement and the warehouse address of the buried location map and floor plan).
6) product quality management system document catalog;
7) operating in vitro diagnostic reagents should be submitted at the same time the following application materials:
① Proposed legal representative of the enterprise, the person in charge of the enterprise's original certificate of academic qualifications, photocopies and biographical data;
② licensed pharmacist qualification certificate and the original letter of appointment, photocopies;
3 competent Inspector's certificate, the original and copy of the letter of appointment or the original and copy of the certificate of inspection-related professional university degree or above, and proof of work experience in inspection-related work for more than 3 years;
④ the scope of products to be operated;
⑤ the proposed place of business, equipment, warehousing facilities and the surrounding sanitary environment and other circumstances;
⑥ the proposed enterprise quality management documents and warehousing facilities, Equipment directory;
8) declaration of the authenticity of the material self-assurance statement, and the material to make a commitment to bear legal responsibility in the event of fraud;
9) Where the application for the enterprise declaration materials, the applicant is not the legal representative or person in charge of the person himself, the enterprise should be submitted to the "letter of authorization," 2 copies.