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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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India Launches Scheme for Promotion of Medical Device Parks
/in India, Latest Updates/by Gunjan VermaThe scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).
Thailand Fast Tracks Class D Medical Device Registration with Singapore Approval Status
/in Latest Updates, Thailand/by Bryan GilburgThe Thai FDA has formally adopted the Regulatory Reliance Program in which Class D (Class 4 in Thailand) medical devices and IVDs listed on the Singapore Medical Device Registry can be exempted from the Specialist Review requirement in Thailand.
India’s CDSCO Updates Classification of Several Product Categories
/in India, Latest Updates/by Gunjan VermaThe updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
The Philippines FDA Issues Guidance for Retailers of Medical Devices
/in Latest Updates, Philippines/by Glend LlantadaOn October 7, 2021, the Philippines FDA released FDA Circular No.2021-0021. The new regulations apply to establishments that provide medical devices Direct to Consumers (DTC) including pharmacies and eCommerce storefronts.
Thai FDA Updates Medical Device Applications Fees
/in Latest Updates, Thailand/by Bryan GilburgOn September 30, 2021 the Thai FDA published (reference Gazette Volume 138, Special Section 239N) a revised fee schedule covering medical and diagnostic device registration applications, license establishments, quality systems, and other review processes.
India Establishes Committees to Streamline Regulatory Framework and Address Denovo Products
/in India, Latest Updates/by Gunjan VermaThe Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.
Indian Industry Association Drafting a Uniform Code for Medical Device Marketing Practices
/in India, Latest Updates/by Gunjan VermaThe updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.
India Temporarily Suspends Compulsory Medical Device Registrations
/in India, Latest Updates/by Gunjan VermaIn public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.