Monday, 13, May, 2019 / Published in China, Medical Devices, News

Medical Device Electronic Submission System

On 07.05.2019, the CMDE (Center for Medical Devic Evaluation), announced the introduction of NMPA’s new eRPS System (Electronic Regulated Product…

Friday, 19, April, 2019 / Published in China, Medical Devices, News

Clinical Trials & Import of Veterinary Drugs

On 28.03.2019, the MOA (Ministry of Agriculture), published a notice regarding two administrative licensing items, which were abolished on 27.02.2019.…

Friday, 19, April, 2019 / Published in China, Medical Devices, News

New Approval Process for Medical Device Clinical Trials

On 01.04.2019, the NMPA (National Medical Products Administration – former NMPA) announced a change in the clinical trial approval process…

Wednesday, 3, April, 2019 / Published in China, Medical Devices, News

Advertisement of Life Science Products

On 13.03.2019, the SAMR (State Administration for Market Regulation) released new review measures for advertisements for pharmaceuticals, medical devices, health…

Friday, 21, December, 2018 / Published in China, Medical Devices, News, Publications

Approval of medical devices for China’s market

In the article A fortunate opportunity? Navigating Chinese regulation challenges to ensure success Anna Fischer from Cisema Hong Kong sets…

Monday, 10, December, 2018 / Published in China, Medical Devices, News

Drug – Medical Device Combination Products

On 14.08.2018, the SAMR defined the 8th batch of Drug – Medical Device Combination Products in their announcement No. 218-2018.…

Monday, 10, December, 2018 / Published in China, Medical Devices, News

New Medical Device Classification Catalogue

On 01.08.2018, the SDA published the interpretation for the new Medical Device catalogue, which contains some changes regarding classifications. Some…

Monday, 10, December, 2018 / Published in China, Medical Devices, News

China SAMR 3 Stipulation Scheme Unveiled

As mentioned in our March/April news: On 13.03.2018, during the 13th National People’s Congress, China’s cabinet decided for the SAMR…

Monday, 10, December, 2018 / Published in China, Medical Devices, News

Medical Device Regulation Index shared on WeChat

On 27.09.2018, the NMPA published two Medical Device Regulation Indices (1998-2013) (NMPA WeChat announcement Nr.37. 2018). The first Index includes…

Monday, 10, December, 2018 / Published in China, Medical Devices, News

Customised Medical Devices

On 29.09.2018, the NMPA released the “Supervision and Management Regulations of Customised Medical Devices” for public comment. Customized medical devices…