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

NMPA Technical Review Guidance Draft for Personalized Implants for Additive Manufacturing

On July 7, 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

Public Consultation on the Inspection Guidelines for Unknown Leachables in Medical Devices

On June 24, the CMDE (Centre for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the technical review…

Friday, 5, June, 2020 / Published in Medical Devices, Webinars

Webinar: MedTech pathway to China: Market opportunities and regulatory hurdles

Date: June 24, 2020Time: 03:00 PM in Hong Kong SAR Are you a MedTech manufacturer looking to expand sales? Interested…

Friday, 5, June, 2020 / Published in China, Medical Devices, News

Sharp Increase of Overseas Applications to enter the Hainan Boao Lecheng International Medical Tourism Pilot Zone

On 18.05.2020, the Hainan MPA (Medical Products Administration) announced a total of 47 overseas applications received for the second round…

Friday, 5, June, 2020 / Published in China, Medical Devices, News

NMPA and Allergan co-hosted the Webinar: Application of RWD and Fast-track Approval in Hainan Boao Lecheng International Medical Tourism Pilot Zone

On 13.05.2020, various departments of the NMPA hosted a webinar with a representative from Allergan, the US global pharmaceutical company…

Wednesday, 3, June, 2020 / Published in China, Medical Devices, News

NMPA Provides Evaluation Guidance on Material Changes for Passive Medical Devices

On 19.05.2020, the NMPA (National Medical Products Administration) addressed the guidance notes (No.33-2020) for NMPA Legal Agents to formulate risk…

Wednesday, 3, June, 2020 / Published in China, Medical Devices, News

Second Overseas Innovative Medical Device in 2020 Approved via Green Channel

On 14.05.2020, the NMPA (National Medical Products Administration) granted the fast-track approval to the global oncology firm Novocure for the…

Wednesday, 3, June, 2020 / Published in China, Medical Devices, News

NMPA Initiates Working Plan for Medical Device Sampling Inspection

On 13.05.2020, the NMPA (National Medical Products Administration) published a notice (No.46-2020) with further details on the recently implemented medical…

Wednesday, 3, June, 2020 / Published in China, Medical Devices, News

Public Consultation on Inclusion of Human Factors for NMPA Medical Device Registrations

On 21.05.2020, the NMPA (National Medical Products Administration) issued a draft guidance document (Official Chinese Version / Unofficial English Translation…

Wednesday, 3, June, 2020 / Published in China, Medical Devices, News

China’s New Standard for Medical Electrical Equipment

On 09.04.2020, the Standardization Administration of China newly released GB 9706.1-2020 to replace GB 9706.1-2007 and GB 9706.15-2008 addressing the…