• 2022-05-26 13:08:24

NMPA, in conjunction with the National Health Commission, has revised the Quality Management Practice for Clinical Trials of Medical Devices, which is hereby promulgated and will take effect from May 1,2022.
Attachment: Quality Management Practice for Clinical Trials of Medical Devices

• 2022-05-26 13:02:57

NMPA made several adjustments to the medical device classification catalogue as summarized below.

• 2021-10-27 07:01:31

In order to strengthen the supervision and guidance of the registration for medical device and further improve the quality of registration review, NMPA has published a new guidance document focusing on equivalence demonstration in clinical evaluation report of intravascular catheters.

• 2021-09-30 07:43:02

On July 22, 2021, the China State Administration for Market Regulation has released a new version of the "Administrative Measures for the Registration and Filing of Medical Devices", which will be executed and come into effect on October 1, 2021.

• 2021-09-29 00:25:11

In order to further standardize the generic names of medical devices and strengthen the management of the whole life cycle of medical devices, NMPA has organized and formulated six naming guidelines.

• 2021-08-30 01:11:33

The Medical Device Division (MDD) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to prove their medical device conform the “Essential Principles of Safety and Performance of Medical Devices” by providing marketing approval from China's National Medical Products Administration (NMPA) and Korea's Ministry of Food and Drug Safety (MFDS).

• 2021-02-19 09:34:08

Recently, NMPA has added more devices into the second batch of medical devices exempt from clinical trials. Medical devices and in-vitro diagnostic reagents on the clinical trial exemption list won’t require completion of clinical trials in order to achieve NMPA certification.

• 2021-02-19 08:45:21

NMPA has introduced important adjustments to the contents of the Classification Catalogue of Medical Devices for 28 classifications of medical devices, including management of 15 classifications of medical devices and catalogue contents of 13 classifications of medical devices.

• 2020-11-27 02:19:08

Compared to domestic and foreign listed products, novel medical devices with new designs, materials or processes, or scope of application and pose a high risk to humans should be approved for clinical trials before the trials can be conducted in China.

• 2020-11-27 02:14:19

From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices.