CFDA Announcement on Releasing GoodManufacturing Practice for Medical Devices

Original link: http://www.sda.gov.cn/WS01/CL0087/111642.html

China Food and Drug Administration
Announcement
[2014] No. 64

Announcement on Releasing Good Manufacturing Practice for Medical Devices

In order to enhance the supervision and administration of, and standardize thequality management of, the medical devices manufacturing, and in accordance with the Regulations for the Supervision and Administration of Medical Devices ( StateCouncil Order No. 650) and the Provisionfor Supervision of Medical DevicesManufacturing (CFDA Order No. 7), China Food and Drug  Administration(“CFDA”) organized the revision of the GoodManufacturing Practice for Medical Devices, and which is hereby released.

　　It is hereby notified!

　　Annex: Good Manufacturing Practice for Medical Devices

　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　China Food and Drug Administration
　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　December 29, 2014

Annex

Good Manufacturing Practice for Medical Devices

Chapter I General Provisions

Article 1    
With a view to ensuring the safety and effectiveness of medical devices and standardizingthe management on quality of medical devices manufacturing, the  GoodManufacturing Practice for Medical Devices (“GMP”) is hereby formulated inaccordance with Regulations for the Supervision and Administration of Medical Devices (State Council Order No.650) and the Provision for Supervision of Medical Devices Manufacturing (CFDA Order No. 7).

Article 2    
Medical device manufacturers (hereinafter referred to as “manufacturers”) shall comply with the requirements set out in the GMP when designing and developing,manufacturing and selling medical devices, as well as providing after-sales services.　

Article 3    
Manufacturers shall establish and improve the quality management system adapted to the medical devices manufactured in combination with product features according to the requirements in the GMP and ensure its effective operation.

Article 4    
Manufacturers shall conduct risk management through the whole process of design and development,manufacture, sales and after-sales service and take the measures adapted toproduct risks.

For full text please click on the link:：http://www.sda.gov.cn/WS01/CL0087/111642.html