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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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China to Require All Electromedical Devices Meet Updated Standards
/in China, Latest Updates/by Bryan GilburgThis adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.
TFDA Implements New Annual Reporting Requirements in Thailand
/in Latest Updates, Thailand/by Bryan GilburgOn June 1, 2022, the Thai FDA released Gazette 138, Section 118 requiring license holders submit annual reports by March 30th of every year.
Philippines FDA Issues New Guidance for Vet Products
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA released an advisory stating veterinary products and medical devices will now be handled exclusively by the CDRR.
TFDA Updates Review Timelines for Medical Device Applications
/in Latest Updates, Thailand/by Bryan GilburgA Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.
Singapore’s HSA Removes Classification and Grouping Inquiry Option
/in Latest Updates, Singapore/by Albert PranotoBeginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.
Singapore’s HSA Issues New Guidance on Special Access Routes (SAR)
/in Latest Updates, Singapore/by Kenna RasiklalSingapore’s Health Science Authority (HSA) recently held a zoom conference call outlining the new requirements for the Special Authorization Routes GN-26 and GN-27 taking effect on April 1, 2022.
Philippines Extends Grace Period for Registration of Certain Medical Devices
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA released a draft Circular announcing an extension of the grace period for certain medical devices by 12 months.
Thai FDA Streamlines Medical Device Registration Process
/in Latest Updates, Thailand/by Bryan GilburgThe TFDA will adjust the registration process and remove the initial pre-submission step beginning March 15, 2022. Beginning April 1, 2022, any classification and/or grouping questions can be submitted through a separate E-submission process for a 500 THB (US$15) fee each.