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CFDA: New Regulation Published for Quality Management of Medical Devices

20. February 2015

An ageing population and improved living standards have created a strong demand for medical devices in China. The safety of those products is ensured by the China Food and Drug Administration (CFDA, chin: 国家食品药品监督管理总局). At the 16th and 17th minister’s working meeting new and revised regulations governing the good practices in supply and medical device manufacturing were adopted. The new requirements are aimed at improving the quality and safety of related medical products.
Team of surgeons in the operating room, female surgeon holdingThe new supply practice went into effect December 12, 2014 and includes 66 articles in 9 chapters. The new requirements are in regards to the quality management of companies producing medical devices. There are more stringent control process covering the purchase, acceptance, storage, sales, transportation and the after-sales service of medical devices.

The revised practice for manufacturing medical devises includes 84 articles in 13 chapters and will go into effect March 1, 2015. The new requirements are aimed at improved quality management at the manufacturing level. These requirements cover personnel, manufacturing facilities, manufacturing equipment, document management, product design and development, procurement, production management, quality control, sales, after-sales service, control of non-conforming products, adverse event monitoring and more.
It is the responsibility of the manufacturer of medical devices to keep up to date with the latest regulations and to maintain compliance. Manufacturers found out of compliance risk fines and/or suspension or revocation of their CFDA registration. To avoid this, it is important to check the revised practices against your current procedures.

As soon as new announcements or information by the CFDA becomes available, we will provide the information in our News-Area. There you can find all relevant information published by other Chinese authorities.

Do you need more information about certifying medical devices through the CFDA? Learn more at our CFDA-Area on our homepage. For more detailed information you can download our “CFDA booklet” free of charge.

If you would like to know more, have questions or concerns, please contact us any time by phone or email .


MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150