Monday, 28, September, 2020 / Published in China, Medical Devices, News

Clinical Trial Guidelines Updated & Various Draft Product Guidelines Issued

On September 2, 2020, the Beijing MPA announced the clinical trial guidelines for medical devices in the Beijing municipalities. Required…

Monday, 28, September, 2020 / Published in China, Medical Devices, News

NMPA Fast-Track Approvals: Applications and Approvals Passed

The NMPA (National Medical Products Administration) accepted 7 domestic and 1 overseas applications for fast-track approval and passed 2 other…

Friday, 21, August, 2020 / Published in China, Medical Devices, News

2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards

On July 7, the NMPA (National Medical Products Administration) issued a notice addressing 6 action items to strengthen the mandatory…

Friday, 21, August, 2020 / Published in China, Medical Devices, News

3 Cosmetics Draft Regulations Issued for Public Consultation

In July 2020, the NMPA (National Medical Products Administration) announced three drafts and launched a public consultation to solicit comments:…

Friday, 21, August, 2020 / Published in China, Medical Devices, News

Various Technical Review Guidelines Updated

In July 2020, the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced its plans to…

Friday, 21, August, 2020 / Published in China, Medical Devices, News

CMDE Recruits Manufacturers of Biomaterials for Tissue Repair

On July 29, 2020 the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) announced a notice…

Friday, 21, August, 2020 / Published in China, Medical Devices, News

New Penalties announced for Medical Device Violations in Beijing

On July 27, 2020 the Beijing MPA (Medical Products Administration) announced the implementation of a grading system for medical device…

Friday, 21, August, 2020 / Published in China, Medical Devices, News

Cutting Edge Tech Developments in China

The “Artificial Intelligent Medical Device Innovation and Cooperation Platform” was established in July 2019 as a subordinate unit under the…

Friday, 21, August, 2020 / Published in China, Medical Devices, News

Reminder for Start of Medical Devices’ UDI Code Labeling Requirement

From October 1, 2020 onwards, the registered applicant/registrant of medical devices listed in the first batch must submit the product…

Friday, 21, August, 2020 / Published in China, IVDs, Medical Devices, News

Extension of Exemption List for Medical Devices and IVDs soon

On July 29, 2020 the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) released a draft…