(a) with the production of medical devices and production sites, 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) 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.
Opening 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 production permits, and submit the following information:
(a) business license, organization code certificate copy;
(b) the applicant company holds the production of medical equipment registration certificate and a copy of the technical requirements of the product
(C) legal representative, a copy of the identity of the person in charge of the enterprise;
(D) production, quality and technical personnel in charge of the identity, qualifications, titles, copies of certificates;
(E) production and management, quality inspection jobs practitioners qualifications, titles list;
(F) the production site of the documents, there are special requirements for the production environment Should also submit a copy of the facilities, environmental documents;
(vii) the main production equipment and inspection equipment directory;
(viii) quality manuals and procedural documents;
(ix) the process flow diagram;
(j) proof of authorization of the person in charge;
(xi) other supporting information.
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration receives the application, shall be dealt with in accordance with the following:
(a) the application is within the scope of its competence, the application information is complete, in accordance with the statutory form, the application shall be accepted;
(b) the application information is incomplete or does not comply with the statutory form, it shall be on the spot or within 5 working days, the applicant shall be informed of all the contents of the need to make corrections, and if not informed after the deadline, the application shall be accepted from the date of receipt of the application information;
(c) the application information can be corrected on the spot, the applicant shall be allowed to make corrections on the spot;
(d) the application does not fall within the purview of the department, the application shall be made instantly inadmissible decisions, and inform the applicant to the The relevant administrative departments to apply. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration to accept or reject the application for a medical device manufacturing license shall issue a notice of acceptance or inadmissibility.
Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall, within 30 working days from the date of acceptance of the application information for review, and in accordance with the requirements of the quality management standard for the production of medical devices to carry out on-site verification. On-site verification should be based on the situation, to avoid duplication of verification. The need for rectification, rectification time is not counted in the audit time limit.
Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to the "Medical Device Manufacturing License"; does not meet the prescribed conditions, to make a written decision not to permit, and explain the reasons.
To start the first class of medical device manufacturers, should be located in the municipal food and drug supervision and management department for the first class of medical equipment production record, submit the record held by the company to produce a copy of the medical device filing voucher and the information provided in Article 8 of these measures (except for the second).
The food and drug supervision and management department shall be on the spot on the integrity of the information submitted by the enterprise to verify that meets the prescribed conditions to be filed, issued by the first class of medical devices production filing voucher.
Medical device production license application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party in accordance with the laws, regulations and the relevant provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; in the review of the medical device production license, the food and drug supervision and management department that relates to the public * * * * major licensing matters of interest, shall provide the applicant with the relevant provisions of the State Food and Drug Administration. Interests of major licensing matters, should be announced to the community, and hold a hearing.
"Medical Device Manufacturing License" is valid for five years, set out the license number, enterprise name, legal representative, responsible person, residence, production address, production range, the licensing department, the date of issuance and validity and other matters. Medical Device Manufacturing License" attached to the production of medical devices product registration form, containing the name of the production product, registration number and other information.
Legal basis: "supervision and management of the production of medical devices" Article XIII "Medical Device Manufacturing License" is valid for five years, set out the license number, enterprise name, legal representative, responsible for the enterprise, residence, production address, production, licensing department, date of issuance and validity and other matters. Medical Device Manufacturing License" with a medical device production product registration form, containing the name of the production product, registration number and other information.