Tuesday, 12, May, 2020 / Published in China, Medical Devices, News

Periodic Risk Evaluation Reports for Medical Device Adverse Events – New Guidelines Issued

On 06.05.2020, the NMPA (National Medical Products Administration) provided important details on the ongoing reporting requirements for NMPA-registered medical devices…

Monday, 11, May, 2020 / Published in Medical Devices, Webinars

Webinar in cooperation with WVIB in Freiburg/Germany

On 05.05.2020, a webinar was held in cooperation with the trade association of industrial enterprises in Baden (German: Wirtschaftsverband Industrieller…

Monday, 4, May, 2020 / Published in China, Medical Devices, News

NMPA issues updated guidance for registration of AI software to assist with responding to the Corona-virus pandemic

Due to shortages of qualified medical staff and consistent with the Chinese government’s emphasis on AI technology, the NMPA has…

Friday, 24, April, 2020 / Published in China, Medical Devices, News

NMPA emergency approval channels for Covid-19 response now closed

We had earlier reported on an emergency approval channel for NMPA approval of non-approved medical devices to combat COVID-19: See…

Monday, 6, April, 2020 / Published in China, Medical Devices, News

First Medical Device NMPA Approval for Real-world Data Application

On 26.03.2020, the NMPA (National Medical Products Administration) approved the US firm Allergan’s glaucoma drainage tube, the first imported medical…

Thursday, 2, April, 2020 / Published in Cosmetics & Ingredients, Medical Devices, Webinars

Cisema Webinar on Certification of Medical and Cosmetic products in China (German)

Since the outbreak of COVID-19, health care has become even more of a focus. China was already the second largest…

Friday, 27, March, 2020 / Published in CCC, CEL, China, CML / SELO, Medical Devices, News

NMPA Project Plan and SAMR Legislative Plan for 2020

On 20.03.20, the NMPA (National Medical Products Administration) announced the 2020 project plan and selection process for 86 medical device…

Wednesday, 25, March, 2020 / Published in China, Medical Devices, News

NMPA 2019 Annual Report for Medical Device Registration

On 18.03.2020, the NMPA (National Medical Products Administration) issued the 2019 Annual Report for Medical Device Registration. In 2019, the…

Tuesday, 24, March, 2020 / Published in China, Medical Devices, News

New NMPA guidelines for QMS

On 17.03.2020, the NMPA (National Medical Products Administration) issued (No.19-2020) the Inspection Guide for the QMS (Quality Management System) of…

Friday, 20, March, 2020 / Published in China, Medical Devices, News

New NMPA Measures for Random Medical Device Checking In-market

On 13.03.2020, the NMPA announced (No.09-2020) the Administrative Measures for the Sampling Inspection on the Quality of Medical Devices. This…