News

Industry requirements, evaluation methods and testing guidelines cover bone implants, medical imaging devices, SaMDs, surgical equipment, test kits, etc.

The NMPA announced 6 principles to strengthen the market surveillance of coronary stents following the centralized procurement process

The CMDE prepared a brief analysis as reference for manufacturers planning to register their drug-device combination products in China

During the past month, the NMPA and CMDE were actively involved in facilitating the fast-track approvals for medical devices in the Chinese market.

Once the sampling inspection procedures in the recent draft amendment is finalized, the NMPA Legal Agents will play a more important role.

NMPA’s recent release of the updated product information of 29 IVD reagents, primarily to down-classify from class III to class II, was long overdue.

The NMPA will issue both electronic and paper certificates to successful registrants during a trial period from October 19, 2020 to August 31, 2021.

This accreditation now means that biological compatibility testing of medical devices conducted in China will more readily be recognized globally.

The CMDE is drafting pre-market evaluation guidelines for AI software in diagnostic pathology to support China’s upcoming 5-year plan

International Medical Device Regulator Forum Accepts China’s Proposal on “Post-Market Clinical Follow-Up Studies” and Seeks Industry Comment

4 draft regulations were released to support the implementation of the CSAR whilst the safety and technical standards for cosmetics will be amended.

In September 2020, the NMPA accepted 2 overseas applications from CooperVision and BIOMERIEUX for prioritized review and approval.

In September 2020, the NMPA issued technical review guidelines for medical devices including 3D-printed lower jaw prosthesis, customized bone implants, etc.

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.