Legal analysis: the third class of medical devices business license: first, the parties to the municipal people's government in charge of drug supervision and management of the location of the municipal government to apply, and submit relevant materials. Then, the receiving department shall review the application information. Finally, a decision shall be made within 20 working days from the date of accepting the application. If the conditions are met, permission shall be granted and a medical device business license shall be issued.
Legal basis: "Supervision and Administration of Medical Devices Regulations" Article 20 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;
(b) there is the production of medical devices for quality inspection of the organization or full-time inspectors As well as inspection equipment;
(C) to ensure that the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) product development, production process documentation requirements.
Article 22 is engaged in the production of Class II, Class III 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 production licenses and submit their compliance with the conditions set out in Article 20 of the Ordinance, as well as proof of the conditions of the production of medical devices and the certificate of registration. 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; do not meet the prescribed conditions, not licensed and a written explanation of the reasons. Medical device production license is valid for 5 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.