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.
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QT Activity: Qualtech Webinar on Korea Market Expansion and China Registration Service Updates will be held on October 20 - September/October 2023
- 2023-09-28 06:42:53
Qualtech is excited to invite you to an insightful webinar: Asia's Business Frontier: Korea Market Expansion & China Registration Service Updates!
More China: NMPA Announcement on Adjusting the Business Scope of the Electronic Regulated Product Submission (eRPS) for Medical Device Registration (No. 11 of 2023) – June/July 2023
- 2023-06-28 09:46:17
Correction action of medical devices is included in the eRPS. The structure of the online submission dossier of corrective action is provided.
More China: NMPA Announcement on Issuing Guidance for Registration of Certain Devices (No. 12&13 of 2023) – June/July 2023
- 2023-06-28 09:43:30
Center for medical device evaluation (CMDE) revised "Guidance for Registration of Intense Pulsed Light Equipment" and "Guidance for Registration of Ophthalmic Optical Instrument".
More China: CMDE Announcement on the Release of a Guidance for the Registration and Review of Radiofrequency Aesthetic Devices (No. 8, 2023) – May/June 2023
- 2023-05-24 07:24:05
In order to standardize the management of radiofrequency aesthetic devices, the CMDE issued the “Guidance for the Registration and Review of Radiofrequency Aesthetic Devices”.
More China: NMPA Announcement on Extending the Validity Period of the Registration Certificate of the COVID-19 Antigen Testing Reagent (2022 No. 114) – January/February 2023
- 2023-01-19 06:07:49
In order to support the supply of antigen testing reagents for COVID-19, NMPA has made related announcements.
More China: NMPA's Circular on the Use of Electronic Payment Forms for Drug and Medical Device Product Registration Fees (No. 37 of 2022) – October/November 2022
- 2022-10-25 07:28:38
NMPA decided to start using electronic payment for drug and medical device registration fees.
More China: NMPA's Notice on the Documents Regarding Requirements for Pre-Assessment of Medical Device Registration (No. 40 of 2022) – October/November 2022
- 2022-10-25 07:24:41
Requirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.
More China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration (Revised Edition 2022)
- 2022-04-27 11:16:17
NMPA 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.
More China: Two Guidelines for Registration and Review of Drug-Device Combination Products Mainly Functioning as Medical Devices – February, 2022
- 2022-02-18 08:10:07
Drug-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.
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