(A) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel;
(B) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment;
(C) have to ensure the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the product development, production process documentation requirements.
Two, for should apply to the location of the province, autonomous region, municipality directly under the Central Food and Drug Administration to apply for production permits, carrying business license, organization code certificate copy, the applicant company holds the production of medical devices registration certificate and a copy of the technical requirements of the product, the legal representative, the person in charge of the enterprise copy of the identity, production, quality and technical responsible person's identity, education, professional title A copy of the certificate, production management, quality inspection positions practitioners list of academic qualifications, titles, production sites, there are special production environment requirements should also be submitted to the facilities, the environment of the copy of the supporting documents, the main production equipment and inspection equipment catalog, quality manuals and procedural documents.
Three, the list of materials required to apply for Class III medical devices:
(a) business license, organization code certificate copy;
(b) the applicant company holds the production of medical devices and product registration certificate and a copy of the technical requirements of the product;
(c) legal representative, the person in charge of the enterprise a copy of the identity certificate;
(d) production (d) production, quality and technical personnel in charge of the identity, education, a copy of the title certificate;
(e) production management, quality inspection positions of practitioners education, title list;
(f) the production site documents, there are special production environment requirements should also be submitted to the facilities, environment, a copy of the supporting documents;
(g) the main production equipment and inspection equipment directory
(viii) quality manuals and procedural documents;
(ix) process flow diagrams;
(x) proof of authorization of the operator;
(xi) other supporting information.
Four, registered Class III medical device company's business scope:
Sales of medical devices Class III: medical electronic instruments and equipment, medical optical instruments, instruments and endoscopic equipment, medical magnetic **** vibration equipment, medical X-ray equipment, operating room, emergency room, diagnostic and treatment room equipment and appliances; Class Ⅱ: clinical test and analysis instruments. Sales of computer software and auxiliary equipment, electronic products, cultural goods, handicrafts (excluding cultural relics), construction materials, machinery and equipment, furniture, instruments and meters; economic and trade consulting.
Retail injection and puncture instruments, medical polymer materials and products, clinical testing and analysis instruments, in vitro diagnostic reagents, medical electronic instruments and equipment, disinfection and sterilization equipment and apparatus.
Fifth, the approval of three types of medical equipment license conditions:
1, the business premises should be used in an area of not less than 40 square meters, branches of legal entities should be used in an area of not less than 25 square meters of business premises (except across the regional municipalities set up); business hearing aids, the business premises should be used in an area of not less than 25 square meters; business contact lenses and nursing fluids, contact lenses and nursing fluid. Business premises should be no less than 10 square meters.
2, the warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
3, quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. Operating single-use sterile medical devices, there should be more than one medical device quality management system internal auditor certificate of internal auditor and other relevant application conditions.
Legal basis
"Regulations for the Supervision and Administration of Medical Devices"
Article 30 Engaged in the production of medical devices, shall have the following conditions:
(a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment, and professional and technical personnel;
(ii) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment;
(iii) to ensure that the quality of medical devices management system;
(iv) with the production of medical devices compatible with the after-sales service capabilities;
(v) in line with the requirements of product development, production process documentation.
Article 32 engaged in the production of Class II, Class III medical devices, should be located in the provinces, autonomous regions and municipalities directly under the Central People's Government of the People's Government Drug Administration to apply for production licenses and submit their compliance with the conditions of Article 30 of the Ordinance and the production of medical devices and the relevant information of the registration certificate.
To accept the application for production license drug supervision and management department shall review the application information, in accordance with the State Council drug supervision and management department to develop the requirements of the quality management standard for the production of medical devices for verification, and from the date of acceptance of the application within 20 working days to make a decision. To meet the prescribed conditions, permission is granted and issued to the medical device production license; does not meet the prescribed conditions, not licensed and a written explanation of the reasons.
Medical device manufacturing license is valid for five years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.