Regulatory News from Across Asia-Pacific
On September 14, the CMDE announced two new additions in the list of class III medical devices requiring clinical trials in China.
The NMPA updated the first batch of medical devices requiring UDI, and extended the UDID’s pilot phase to January 1, 2021
The NMPA optimizes the approval process for overseas manufacturers intending to produce their already registered class II or III medical devices in China.
The SAMR launched a public consultation on 6 draft documents covering technical requirements, manufacturing processes and excipients for health food filing.
China has carried out a series of measures to support the CSAR (Cosmetic Supervision and Administration Regulation) and the cosmetics regulatory framework.
The NMPA released an introductory video about the online UDI database, soon to be implemented for the first batch of medical devices on October 1, 2020.
The China's State Council announced the regulatory framework for AI, and the plan to implement standards for AI developments in the healthcare industry.
Guidelines covering technical review / clinical trials / clinical evaluation for the registration of medical devices in China
2 medical devices were passed for the fast-track approval, whilst the NMPA accepted the applications for the fast track approval of 8 medical devices.
NMPA Issues 2019 Annual Report, Strengthening Scheme and Updates on Medical Device Mandatory Standards in China
In July 2020, the SAMR announced two drafts concerning health food products and launched the public consultation to solicit comments
In July 2020, the NMPA (National Medical Products Administration) announced three drafts and launched a public consultation to solicit comments
In July 2020, the CMDE issued a notice requesting domestic and overseas manufacturers‘ assistance to draft the technical review guidelines for 15 medical...
The CMDE asks for the input from medical device manufacturers in the field of tissue regeneration for support in their research and technology development.
The Beijing MPA has announced the implementation of a grading system for medical device violations in Beijing.
The “Artificial Intelligent Medical Device Innovation and Cooperation Platform” announced their recent developments concerning AI medical devices
From October 1, 2020 onwards, the registered applicant/registrant of medical devices listed in the first batch must submit the product identification (DI)
On July 29, 2020 the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration) released a draft of the proposed amendment to the list of medical devices and IVDs to be exempted from clinical trials:
The draft proposes to add 53 medical devices (Class II: 34; Class III: 19) and 15 IVDs (Class II: 13; Class III: 2) to the clinical trial exemption list. Also, the names and descriptions of 11 medical devices (Class II: 9; Class III: 2) are proposed for revision, while there are 2 medical devices being combined with other products.
Here are the links to:
Proposed amendment for the list of medical devices to be exempted from clinical trials
Proposed amendment for the list of IVDs to be exempted from clinical trials
The CMDE is currently soliciting for public comments, and the public consultation ends on August 31, 2020.
By Jacky Li. Contact Cisema if you would like to learn more.
On July 31, 2020, the Beijing MPA (Medical Products Administration) made an announcement to implement stricter supervision on medical cosmetology products.
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
Contact: Dr. Andreas Berghammer , Tel.: +49 (0) 89-899679-17
Anja Weber, Tel.: +49 (0) 89-899679-35
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