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.
了解更多The CMDE has compiled the medical device registration review guideline catalog published from 2007 to 2023.
了解更多The Medical Device Authority (MDA) announced on November 28th that the implementation of a fully electronic medical device registration certificate will start on November 1, 2023. MDA will only issue an electronic registration certificate for applications approved after November 1, 2023.
了解更多The Medical Device Authority (MDA) announced transitional period on July 14th for the registration of Covid-19 test kits, which the registration applications would be subjected to the compliance assessment procedure conducted by the compliance assessment body (CAB).
了解更多The Philippine Food and Drug Administration (PFDA) released the 2023 edition of the citizen charter, including updates related to the Center for Device, Radiation Health, and Research (CDRRHR).
了解更多The Minister of Finance promulgates Circular 44/2023/TT-BTC dated June 29, 2023, and Circular 59/2023/TT-BTC dated August 30, 2023, to adjust administrative fees in the health sector.
了解更多The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.
了解更多The MDA announced a transition period for the implementation of electronic medical device registration certificates on May 22nd, 2023. This announcement is intended to provide information on the use of Electronic Medical Device Registration certificates, which will be fully implemented on January 1st, 2024, and no more physical medical device registration certificates will be issued by MDA.
了解更多Qualtech's big topic for this month's edition provides an overview of the Unique Device Identification (UDI) system implemented by territories serviced by Qualtech for medical devices. The UDI system aims to improve patient safety, traceability, and identification of medical devices on the market. The implementation of the UDI system offers benefits such as faster traceability, standardized post-market safety activities, and improved buying and waste disposal policies.
了解更多Correction action of medical devices is included in the eRPS. The structure of the online submission dossier of corrective action is provided.
了解更多Center for medical device evaluation (CMDE) revised "Guidance for Registration of Intense Pulsed Light Equipment" and "Guidance for Registration of Ophthalmic Optical Instrument".
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