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- 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
- 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
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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.
Indonesia Revamps eCatalogue Procurement System
/in Indonesia, Latest Updates/by Ilham HidayattulahOn February 11th and 14th, the Ministry of Health of the Republic of Indonesia implemented significant structural and procedural changes to the government procurement system known as e-Catalogue as it applies to medical devices (reference announcement KN.01.04/3/630/2022). Under the new rules, oversight of the e-Catalogue has been moved under the Ministry of Health and will not require negotiations.
India’s CDSCO Expected to Begin Enforcing Local BIS Standards
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.
India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.