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- China’s NMPA Updates Medical Device Classification Catalogue September 19, 2023
- Thai FDA Drafting New Guidance for SaMD and AI Device Registration September 18, 2023
- China NMPA Adds 47 Products to Clinical Trial Exemption List August 22, 2023
- New Plastic Waste (PWM) Rules Affect Medical Device Importers in India August 22, 2023
- China to Regulate Medical Device Advertising August 2, 2023
- Thai FDA Improves Medical Device Application Process June 27, 2023
- Hong Kong Government Prioritizes Purchase of Locally Registered Medical Devices June 15, 2023
- Vietnam Adjustments to the Medical Device Application Requirements June 7, 2023
- An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases May 30, 2023
- Vietnam Diagnostic Imaging Center Hosts AI Software Conference May 11, 2023
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Vietnam’s DMEC Provides Update on Issuance of C/D Licenses
/in Latest Updates, Vietnam/by David VoOn September 14, 2022, the DMEC held a seminar to update the medical device industry on the issuance of Class C and D MA Licenses.
Philippines FDA Publishes Revised Draft of New IVD Regulations
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA hosted a public consultation to introduce a revised draft version of new IVD Regulations along with a definitive timeline for implementation.
Taiwan’s New TCP III in Effect as of January 1, 2022
/in Latest Updates, Taiwan/by Eric LeungThe Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.
Hong Kong to Pilot Prioritizing Some Listed Medical Devices
/in Commercial Services, Hong Kong, Latest Updates/by Eric LeungHong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.
How New EU MDR Requirements Will Affect Registrations in Asia
/in China, Hong Kong, India, Indonesia, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam/by Bryan GilburgAs manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
Thai FDA Implements Initial Screening Step to Submission Process
/in Latest Updates, Thailand/by Bryan GilburgBeginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.
Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue
/in Indonesia, Latest Updates/by Ilham HidayattulahOn July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,
Medical Device Advertising Requirements in Asia
/in Australia, China, Commercial Services, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Russia, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Bryan GilburgIn addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.