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Medical device manufacturing

Chapter III medical device production

20th medical equipment production activities, subject to the following conditions:

(A) fitting in with the production of medical devices production sites, environmental conditions, equipment, and professional and technical personnel;

(B) on production of quality control of medical devices agency or full-time inspectors and inspection equipment;

(C) ensure medical device quality management system;

(D) fitting in with the production of medical equipment service;

(E) the requirements set out in product development, production process.

21st engaged in production of class I medical devices from manufacturers to the local district people's Government municipal food and drug supervision and management departments and submitted to it in accordance with the conditions specified in section 20th supporting information.

22nd in class II and class III medical device production, production enterprises should be located, provinces, autonomous regions and municipalities apply for food and Drug Administration license and submit proof of the condition of the 20th article of the Ordinance have been met information and the production of medical devices in the registration form.

Accepts an application for licensing of food and drug supervision and management departments should be within 30 working days from the date of receipt of application materials for the audit, according to the State food and drug supervision and management departments of medical device manufacturing practices requirements for verification. To meet the required conditions, grant permission and issue medical device manufacturing license; does not meet the requirements of no permission and to state the reason in writing.

Medical device manufacturing license is valid for 5 years. Needs to extend the expiry, in accordance with the legal provisions concerning administrative license for continued clearance.