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Home > Medical Devices & Pharmaceuticals
China Issued the Standards on the Quality Management of Using Medical Devices (Draft for Comment)

On May 29, 2014, State Food and Drug Administration issued "Shi Yao Jian Xie Jian Bian Han [2014] No.51" to seek public comments for the Standards on the Quality Management of Using Medical Devices (Draft for Comment) (“The Standards”). The deadline for comment submission is June 15, 2014. Consisting of eight chapters, the Standards will be the basic requirements for the quality management during the use of medical devices by all entities.  All comments shall be sent to qxjglt@cfda.gov.cn.  You may also contact admin@compliance.com.cn for the submission of your comments.

 

The first chapter of the Standards is about general principles.  An entity shall make and take effective quality management system in the process of procurement, inspection, storage, maintenance, repair, use and disposal of medical devices to make sure they are used safely.

 

Chapter 2 is about entities and personnel. An entity in the use of medical devices shall establish quantity control system, which includes quality management organization, personnel, equipment and facilities, and quality management documents.

 

The quality management personnel could be full time or part time. In any event, the personnel shall have expertise and knowledge, professional titles and quality management experience. The managerial personnel shall be familiar with the concerned laws, regulations on medical devices. They shall take technical training on a routine basis.

 

Chapter 3 is about procurement. An entity using medical devices shall establish quality management system on procurement of medical devices. All medical devices shall be procured uniformity by a specific organization. An entity using medical devices shall establish procurement records, which include the names, specifications, registration certificate numbers, as well as some other concerned information of medical devices.

 

Chapter 4 is about inspection. An entity using medical devices shall establish quality management system on inspection. The inspection record of a medical device shall be maintained until the expiration date of that medical device or after two years when the medical device is stopped from being used. However the inspection record of implantable or interventional medical devices shall be maintained permanently.

 

Chapter 5 is about storage. An entity using medical devices shall establish quality management system on storage and warehousing. Chapter 6 is about maintenance, repair and after sale services. Chapter 7 is about use, transfer and disposal. Chapter 8 is miscellaneous.

 

For the Chinese version, please follow the link.

 

 

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