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- Hong Kong MDD Adds China and Korea to List of Reference Countries January 29, 2024
- Thailand FDA to Decrease Registration Application Processing Times January 25, 2024
- Thailand FDA to Improve Medical Device Advertising Review Times January 22, 2024
- Hong Kong MDD Issues New Technical Reference Document for AI-MD January 22, 2024
- Hong Kong MDD Issues Technical Reference for SaMD and SiMD January 17, 2024
- Philippines FDA Announces New Fee Schedule for Medical Devices December 15, 2023
- MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong December 7, 2023
- CDSCO Issues Updates to IVD Classification List in India November 29, 2023
- Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit November 2, 2023
- Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS October 17, 2023
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Hong Kong MDD Adds China and Korea to List of Reference Countries
/in Hong Kong, Latest Updates/by Bryan GilburgStarting January 1st, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the National Medical Products Administration (NMPA) of Mainland China and the Ministry of Food and Drug Safety (MFDS) of Korea as support of compliance of the medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.
Thailand FDA to Decrease Registration Application Processing Times
/in Latest Updates, Thailand/by Noi SuwannabotThe Thai FDA hosted a seminar for public discussion and training of the full CDST application, which was attended by Asia Actual Thailand personnel. At the event, the Thai FDA announced its intention to decrease the application pre-screening time from 30 days to 1 working day.
Thailand FDA to Improve Medical Device Advertising Review Times
/in Latest Updates, Thailand/by Noi SuwannabotIn a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the approvals of advertisement applications.
Hong Kong MDD Issues New Technical Reference Document for AI-MD
/in Hong Kong, Latest Updates/by Bryan GilburgOn January 3, 2024, Hong Kong’s Medical Device Division (MDD) issues the Technical Reference document TR-008: Artificial Intelligence Medical Devices (AI-MD). It provides clarity for devices using AI (AI-MD) and machine learning, including Continuous Learning Capability (CLC) and the technical requirements expected for listing these medical devices on the Medical Device Administrative Control System (MDACS).
Hong Kong MDD Issues Technical Reference for SaMD and SiMD
/in Hong Kong, Latest Updates/by Bryan GilburgHong Kong’s Medical Device Division has released a new technical reference document related to software medical devices (SaMD and SiMD). Released on December 29, 2023, TR-007: Software Medical Devices and Cybersecurity, aims to provide more clarity for Software in a Medical Device (SiMD) and standalone software (Software as a Medical Device (SaMD)), specifically related to definitions, classification and cybersecurity.
Philippines FDA Announces New Fee Schedule for Medical Devices
/in Latest Updates, Philippines/by Charmaine RosonOn November 29th and 30th the Philippines FDA hosted a public forum to review and field questions on plans to change the fee schedule for processing registration applications as outlined in a recent draft Administrative Order (available here) and it’s corresponding Annexes.
MDD Issues Guidance on Making Changes to Medical Device Licenses in Hong Kong
/in Hong Kong, Latest Updates/by Albert PranotoOn November 30th, the Hong Kong Medical Device Division (MDD) issued formal guidance on the requirements to make changes to medical device licenses registered in the Medical Device Administrative Control System (MDACS).
CDSCO Issues Updates to IVD Classification List in India
/in India, Latest Updates/by Gunjan VermaThe Central Drugs Standard Control Organisation (CDSCO) of India issued a notice (PDF) on October 25, 2023 classifying in-vitro diagnostic (IVD) medical devices under medical device rules. The updates to IVD classification in India include intended use, associated risk, and other parameters.