Legal analysis: engaged in the production of medical devices, the manufacturer shall apply to the local food and drug supervision and management department of the people's government of the provinces, autonomous regions and municipalities directly under the Central Government to apply for a production license and submit its compliance with the conditions of the information and the production of medical devices registration certificate. Acceptance of applications for production authorization of food and drug supervision and management department shall be accepted within 30 working days from the date of application information for review, in accordance with the State Council food and drug supervision and management departments to develop the requirements of the quality management standard for the production of medical devices for verification. To meet the prescribed conditions, permission is granted and issued to the production of medical devices license; does not meet the prescribed conditions, not licensed and a written explanation of the reasons.
Legal basis: "Supervision and Administration of Medical Devices Production"
Article VIII of the second class, the third class of medical device manufacturers, should be located in the province, autonomous region, municipality directly under the Central Food and Drug Administration to apply for a production license, and submit the following information:
(a) business license, a copy of the organization code certificate;
(ii) the application for the enterprise holds the production of medical devices;
(b) the production of medical devices; (c) the production of medical devices, medical devices and medical equipment, medical devices and medical equipment, medical devices and medical equipment, medical devices and medical devices, medical devices and medical devices. ) the applicant company holds a copy of the registration certificate of the production of medical devices and product technical requirements;
(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 of the person, academic qualifications, titles;
(e) production management, quality inspection positions of the practitioner's academic qualifications, titles list;
(f) the production management, quality inspection positions of practitioners; < /p>
(f) the production site documents, there are special production environmental requirements should also be submitted to the facilities, environment, a copy of the documents;
(g) the main production equipment and inspection equipment directory;
(h) quality manuals and procedural documents;
(ix) process flow diagrams;
(j) proof of authorization of the operator;
(xi) other supporting information.
Article IX provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration upon receipt of 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 five working days to inform the applicant of the need to supplement the information;
(x) other supporting information. Within five working days, the applicant shall be informed of all the contents of the need to make corrections, late notification, since the date of receipt of the application information is accepted;
(c) application information can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
(d) the application does not fall within the purview of the department, it should be immediate inadmissibility of the decision, 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 authorization of the production of medical devices, shall issue a notice of acceptance or inadmissibility.
Article X 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, make a written decision not to permit, and explain the reasons.
Article XI of the first class of medical equipment manufacturers, should be located in the municipal food and drug supervision and management department for the first class of medical equipment production record, submit a copy of the filing of the record held by the company's production of medical devices for the record vouchers and the information provided for in Article 8 of these measures (except for the second item).
The food and drug supervision and management departments should be on the spot on the integrity of the information submitted by the enterprise to check, in line with the prescribed conditions to be filed, issued by the first class of medical devices production filing vouchers.