About US

Beijing, China

Email:

customer@cnphds.com

Phone:

+86-10-84466227

+86-10-84466228

+86-10-84466229

View Offices Request a Proposal
2015

CFDA issues Good Manufacturing Practice for Medical Devices

Published:2015-01-19
In order to strengthen the supervision and management of medical device manufacturing, standardize quality management, and further ensure the safety and effectiveness of medical devices, China Food and Drug Administration (CFDA) organized the revision of the Good Manufacturing Practice for Medical Devices (interim) in accordance with the newly revised Regulations for the Supervision and Administration of Medical Devices and Administrative Measures for the Supervision of Medical Device Manufacturing. The revised Good Manufacturing Practice for Medical Devices was adopted at the 17th minister’s working meeting of CFDA on December 12, 2014, promulgated on December 29, 2014 and will come into effect as of March 1, 2015. The revised Good Manufacturing Practice for Medical Devices comprises 84 articles in 13 chapters, which requires medical device manufacturers to set up and improve the quality management system in accordance with this GMP, and specifies relevant requirements on organization and personnel, premises and facilities, equipment, document management, design and development, procurement, production management, quality control, sales and after-sales services, control of nonconforming products, adverse event monitoring, analysis and improvement etc.