Tuesday, 17, March, 2020 / Published in China, Medical Devices, News

NMPA Essential Principles of Safety and Performance of Medical Devices

On 10.03.2020, the NMPA published (No.18-2020) the essential principles of safety and performance of medical devices. The principles describe the…

Friday, 13, March, 2020 / Published in Medical Devices, Webinars

Cisema Webinar on Medical and Cosmetic Product Certification

China is now the second largest market for the healthcare sector and the largest consumer of cosmetics in the world.…

Thursday, 12, March, 2020 / Published in China, Medical Devices, News

China’s Coronavirus Emergency Response for Urgently Needed Medical Devices

Since the Coronavirus outbreak, the prevention and control work were deployed as the top priority of the China government at…

Thursday, 12, March, 2020 / Published in China, Medical Devices, News

China’s Regulatory Pathway for Customized Medical Devices (CMDs)

On 04.07.2019, the China NMPA (National Medical Products Administration) and NHC (National Health Commission) jointly published the Notice (No.53-2019) in…

Thursday, 12, March, 2020 / Published in China, Medical Devices, News

From foreign- to China-made medical devices

On 05.03.2020, the China NMPA (National Medical Products Administration) has launched a public consultation concerning the transfer of NMPA certificates…

Friday, 6, March, 2020 / Published in Medical Devices, Webinars

Cisema Webinar on Selling Medical Devices in China

On 4.3.2020, the China-Britain Business Council (CBBC) and Cisema held a webinar together to talk about the market, regulations and…

Friday, 14, February, 2020 / Published in China, Medical Devices, News

Filing of Imported Non-Special Use Cosmetics with Beijing MPA

On 20.01.2020, the Beijing MPA (Medical Products Administration) announced (No.6-2020) a list of administrative measures for the filing process of…

Tuesday, 28, January, 2020 / Published in China, Medical Devices, News

China’s Recent Measures for the Urgent Approval of Medical and Health Products Amid Coronavirus Outbreak

On 23.01.2020, the Ministry of Commerce of the PRC announced (No.3-2020) the list of intermediary services and administrative examinations and…

Friday, 3, January, 2020 / Published in China, IVDs, Medical Devices, News

New Clinical Trial Exemption Lists for Medical Devices and IVDs

On 20.12.2019, the China NMPA (National Medical Products Administration) announced (No.91-2019) that it would add 148 medical devices and 23…

Friday, 3, January, 2020 / Published in China, Medical Devices, News

Clinical Evaluation Reports can be Created Based on Real-World Data

The China NMPA (National Medical Products Administration) is seeking input on whether real world data can be used for Clinical…