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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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Vietnam Releases New Medical Device Regulations
/in Latest Updates, Vietnam/by David VoThe MOH officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device registration process in Vietnam.
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.