Monday, 27, July, 2020 / Published in Medical Devices, News, Webinars

Webinar: International Market Access Series – Go China

Organizer: BioM Biotech Cluster Development GmbH Date:  July 30, 2020 Time: 10:00 – 12:00 pm (CET) Venue: Online Register here on organizer’s website…

Thursday, 23, July, 2020 / Published in Medical Devices, News, Webinars

Webinar: MedTech pathway to China: Market opportunities, regulatory hurdles and recent updates

Organizer: SPECTARIS GmbH Date: October 14, 2020 Time: 10:00 am – 11:30 am (CET) Venue: Online Register here on organizer’s website Contact: Ms. Peggy Zimmermann,…

Thursday, 23, July, 2020 / Published in Medical Devices, News, Webinars

Webinar: Medical Devices in China

Organizer: FORUM • Institut für Management GmbH Date: Part I + II on August 25 – 26, 2020 | Part III on…

Friday, 17, July, 2020 / Published in China, Medical Devices, News

New NMPA Guidelines on Periodic Risk Evaluation Reports (PRER) for Medical Device Adverse Events

On July 2, the NMPA (National Medical Products Administration) released the updated guidance document for preparing the periodic risk evaluation…

Friday, 17, July, 2020 / Published in China, Medical Devices, News

NMPA Draft Catalog of Class III Medical Devices Requiring Clinical Trials

On June 24, the NMPA released the draft catalog of class III medical devices requiring clinical trial approval. In the…

Friday, 17, July, 2020 / Published in China, Medical Devices, News

NMPA Major Updates Concerning Software as Medical Device (SaMD)

On June 4, the NMPA (National Medical Products Administration) published (No.57 – 2020) the guidelines for on-site inspections on standalone…

Friday, 17, July, 2020 / Published in China, Medical Devices, News

New Regulation for Overseas Medical Devices in Hainan

On June 2, the Hainan MPA announced (No.28 – 2020) the implementation of the new regulation to support the urgent…

Friday, 17, July, 2020 / Published in China, IVDs, Medical Devices, News

NMPA Major Updates Concerning IVDs

On June 9, the CMDE (Center of Medical Device Evaluation) of NMPA (National Medical Products Administration) announced the initiative to…

Friday, 17, July, 2020 / Published in China, Medical Devices, News

15 New NMPA Technical Review Guidelines for Medical Device Registrations

On June 5, the NMPA issued the technical review guidelines (No. 36 – 2020) for the registration of the following…

Friday, 17, July, 2020 / Published in China, Medical Devices, News

Technical Review Guidance Draft for the NMPA Registration of Citric Acid Disinfectants

On July 1, the CMDE (Centre for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the draft guidance…