Wednesday, 20, November, 2019 / Published in China, Health Foods & Supplements, Medical Devices, News, Pharma & Biotech

Public Consultation on the Measures of Review Management on Advertising for Health Food, FSMP, Drug Products and Medical Devices

From October 25th to November 1st, China SAMR publicly solicited opinions upon its release of the third draft on the…

Friday, 15, November, 2019 / Published in China, Medical Devices, News

UDI Requirements for the First Batch of Medical Devices

Following the announcement of the implementation of the UDI for Medical Devices, China NMPA held an informational workshop seminar and…

Tuesday, 3, September, 2019 / Published in China, Medical Devices, News

Marketing Authorization Holder (MAH)

From 01.01.2020, every products must have a Marketing Authorization Holder (MAH), which is responsible for the entire supply chain, including…

Tuesday, 3, September, 2019 / Published in China, Medical Devices, News

Unique Identification System (UDI) of Medical Devices

In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory…

Saturday, 3, August, 2019 / Published in China, Medical Devices, News

New Clinical Trial Exemption List

On 01.08.2019, the CMDE (Center for Medical Device Evaluation), published a revised “Clinical Trial Exemption List for Medical Devices”. 101…

Thursday, 1, August, 2019 / Published in China, Medical Devices, News

Definition of Drug/Device Combination Products

On 31.05.2019, the NMPA released a notice on the definition of drug/device combination products (No. 28 of 2019). It was…

Thursday, 1, August, 2019 / Published in China, Medical Devices, News

Unique Identification for Medical Devices

On 03.07.2019, the NMPA initiated the Pilot Work Plan for the “Unique Device Identification” (UDI) (No.56-2019), as announced in February…

Thursday, 1, August, 2019 / Published in China, Medical Devices, News

Medical Device Electronic Submission System (eRPS)

On 31.05.2019 and 06.06.2019, the NMPA (National Medical Products Administration) and CMDE (Center for Medical Devic Evaluation) released three announcements…

Friday, 19, July, 2019 / Published in China, Medical Devices, News

Examination of Medical Device Applications

On 12.07.2019, the NMPA released a draft for the examination requirements of medical device applications (No. 42-2019). The CMDE of…

Sunday, 19, May, 2019 / Published in China, Medical Devices, News

Lifetime of Active Medical Devices

On 14.05.2019, the NMPA (National Medical Products Administration) updated technical review guidelines on the timeline of active medical devices (No.…