CHINA: Medical Device Registration Review Guideline Catalog - February/March 2024
- 2024-03-01 08:59:50
The CMDE has compiled the medical device registration review guideline catalog published from 2007 to 2023.
MoreThe CMDE has compiled the medical device registration review guideline catalog published from 2007 to 2023.
MoreCorrection action of medical devices is included in the eRPS. The structure of the online submission dossier of corrective action is provided.
MoreNMPA decided to start using electronic payment for drug and medical device registration fees.
MoreRequirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.
MoreNMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.
MoreDrug-device combination products that mainly function as medical devices (referred to as drug-device combination medical devices in this guideline) are expected to make prevention and treatment of diseases more effective, but may also lead to new technical concerns. Therefore, NMPA formulated two guiding principles to further guide the applicant's preparation for the registration application for drug-device combination medical devices, and to encourage the innovative development of such products.
MoreClinical trial data is one of the important supporting documents for evaluating the safety and effectiveness of medical devices. Standardizing the collection, sorting, analysis, and submission of medical device clinical trial data will not only improve the quality of clinical trial implementation and management but also assist the regulatory agency to understand and review the development of clinical trials quickly and efficiently.
MoreThe “Administrative Measures for the Registration and Filing of Medical Devices” have been adopted at the 11th executive meeting of the State Administration for Market Regulation on July 22, 2021. The measures have subsequently been promulgated and have come into effect on October 1, 2021 via Decree No. 47.
MoreOn July 22, 2021, the China State Administration for Market Regulation has released a new version of the "Administrative Measures for the Registration and Filing of Medical Devices", which will be executed and come into effect on October 1, 2021.
MoreCMDE has added one more step to confirm the information shown on the medical device registration certificate and its attachments in the process of technical review from June 7, 2021.
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