Hong Kong DoH has updated the Guidance Notes for Overview of the Medical Device Administrative Control System

On 4 November 2020, the Hong Kong Department of Health has issued a new version of Guidance Notes: GN-01 Overview …

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NMPA issues a Circular on the Registration of Medical Devices for Urgent Clinical Needs

This circular, dated 29 October 2020, specifies measures related to the review and approval of medical devices for urgent clinical …

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Malaysia MDA Launches New Version of Search System MEDICAL DEVICE AUTHORITY REGISTER for Registered Medical Devices and Licensed Establishments

On 4th November 2020, the Medical Device Authority of Malaysia issued an announcement to announce that the old PBPP Search …

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Australia TGA Issued a New Version of Priority Applicant Guidelines for Medical Devices (including IVDs)

TGA has issued a new version of priority applicant guidelines for medical devices (including IVDs) The purpose of these guidelines …

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Taiwan’s Guidance on Registration of Artificial Intelligent / Machine Learning-Based Software as a Medical Device (AI/ML-Based SaMD)

The Taiwan Food and Drug Administration has released a guideline pertaining to the application of artificial intelligence related to medical …

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Singapore HSA to implement Medical Device Unique Device Identification (UDI) system

The Medical Devices Branch had organized a webinar on the Medical Device (MD) Unique Device Identification (UDI) System in Singapore …

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Australia TGA changes ARTG Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices

From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian …

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Singapore HSA Published Document Relating to Change Applications Arising from the EU MDR/IVDR related changes to registered medical devices

With EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR), the related changes will impact …

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Thailand FDA issued an Announcement on Regulations, Procedures and Conditions for Providing Academic Documents for Medical Devices

The announcement was issued to confirm the standards of quality, efficacy and safety for medical devices for review by or …

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