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- Key Takeaways from Vietnam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
- Indonesia Invests in Quality Healthcare Access May 22, 2024
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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.
Registering Innovative Medical Devices in India
/in India, Latest Updates/by Gunjan VermaInnovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.