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- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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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.
Thai FDA Updates List of Chemical Pollutants
/in Latest Updates, Thailand/by Bryan GilburgThe TFDA has updated their list of chemical pollutants to comply with the Stockholm Convention on Persistent Organic Pollutants.