When did the Code for the Quality Management of Medical Device Manufacturing come into effect?

In order to strengthen the supervision and management of medical device production, standardize the quality management system for the production of medical devices, according to the "supervision and management of medical devices regulations" and related regulations, the State Bureau of Organization of the formulation of the "production of medical devices quality management standard (for trial implementation)". Now issued to you, please comply with the implementation.

State Food and Drug Administration

December 16, 2009

Medical Device Manufacturing Quality Management Standards (Trial)

Article 1 In order to strengthen the supervision and management of the production of medical devices, standardize the quality management system for the production of medical devices, in accordance with the "Regulations for the Supervision and Management of Medical Devices" and relevant regulations, to formulate the specifications.

Second, this specification is the basic guidelines for the production of medical devices quality management system, applicable to the design and development of medical devices, production, sales and service of the whole process.

Article 3 The medical device manufacturer (hereinafter referred to as the manufacturer) should be based on the characteristics of the product, in accordance with the requirements of this specification, the establishment of quality management system, and maintain effective operation. As a component of the quality management system, the production enterprise shall implement risk management in the whole process of product realization.