Please ask a class of medical devices production record whether the company needs to carry out on-site audits?

A class of regulations do not require on-site audits, but depending on the requirements of specific provinces and cities. Fire protection is a must, environmental assessment is not necessary. What products do you plan to produce?

Article 20 is engaged in the production of medical devices, shall have the following conditions:

(a) with the production of medical devices compatible with the production site, environmental conditions, production equipment, as well as professional and technical personnel;

(b) there is the production of medical devices for the quality of the institution or a full-time inspectors and inspection equipment;

(c) Have a management system to ensure the quality of medical devices;

(d) with the production of medical devices compatible with the after-sales service capabilities;

(e) product development, production process documentation requirements.

Article 21 engaged in the production of Class I medical devices, by the manufacturer to the municipal people's government of the location of the municipal food and drug supervision and management department for the record and submit its compliance with the conditions set out in Article 20 of these Regulations to prove the information.