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

New Guidelines for Sterile Medical Devices

On 08.10.2018, the CMDE released new guidelines for the technical review of the sterilization processes of sterile medical devices for…

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

New Clinical Trial Exemption List

On 30.09.2018, the NMPA published a revised “Clinical Trial Exemption List for Medical Devices and IVDs”, which was immediately implemented…

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

New Functions of the Technical Review Consultation Platform

On 07.09.2018, the CDME added two new functions based on the original online reservation consultation platform for medical devices in…

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

Post-Marketing Responsibilities of Medical Device Manufacturers

On 13.08.2018, the Chinese NMPA released the “Measures for Monitoring and Reassessing Adverse Events of Medical Devices” (NMPA Decree No.…

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

Preview of Supplementary Files Available to First-Time Medical Device Registrants

On 12.09.2018, the CMDE (Center for Medical Device Evaluation) announced that they will provide a pre-reviewing service for supplementary documents…

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

Cross-Border-E-Commerce

On 21.11.2018, Premier of the State Council, Li Keqiang, announced the extension of Cross-Border-E-Commerce (CBEC) beyond 31.12.2018. CBEC enables companies…

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

Review for Innovative Medical Devices

On 05.11.2018, the NMPA (former NMPA) published the “Special Approval Procedures for Innovative Medical Devices” (NMPA No. 83-2018), which will…

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

NMPA (former NMPA) online

On 04.11.2018, the new official website of NMPA (National Medical Products Administration) – former NMPA (China Food and Drug Administration)…

Wednesday, 31, January, 2018 / Published in China, Medical Devices, News

NMPA: Funding for Testing of Medical Devices

Funding for Testing of Medical Devices. On 17.11.2017 the NMPA (China Food and Drug Administration) published a notice announcing that…

Wednesday, 20, December, 2017 / Published in Medical Devices, Webinars

Webinar: Opportunities in China’s Medical Device Market

Webinar: Opportunities in China’s Medical Device Market. Anna Fischer, Cisema (Hong Kong) Limited, gave a talk on medical device registration…