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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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Australia’s SaMD Regulatory Deadline
/in Australia, Latest Updates/by Bryan GilburgBeginning on November 1st, 2024, Australia’s Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.
Thai FDA Regulatory Documentation Exemptions
/in Latest Updates, Thailand/by Noi SuwannabotMarch 12, 2024: the Thai FDA released draft guidance updating the list of required documentation for Full and Concise Evaluation. For manufacturers registering a medical device in Thailand, certain documents are no longer required.
Hong Kong MDD Adds Singapore as Reference Country
/in Hong Kong, Latest Updates/by Bryan GilburgStarting April 2nd, 2024, the Hong Kong Medical Device Division (MDD) accepts, on a regular basis, the marketing approvals obtained from the the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.
Philippines Incentivizing Local Medical Device Manufacturing
/in Latest Updates, Philippines/by Glend LlantadaOn March 14th, 2024, the Philippines FDA announced plans to accelerate medical device and pharma manufacturing through proposed ecozones.
China’s Third Batch of UDI Implementation Deadline in June
/in China, Latest Updates/by Bryan GilburgReminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.
Thai FDA Reduces Application Review Time
/in Latest Updates, Thailand/by Noi SuwannabotOn February 21st, 2024 the TFDA provided data to show a reduction in application review times and increased accessibility with their digital service system.
Vietnam’s MoH Updates Class C and D Application Requirements
/in Latest Updates, Vietnam/by David VoPer Decree 07/2022, the application requirements for new Class C and D applications submitted to the Vietnamese Ministry of Health (MoH) after January 1, 2024 will need to be in ASEAN Common Submission Dossier Template (CSDT) format, with the addition of a Vietnamese IFU.
India Changes Medical Device Application Processing System
/in India, Latest Updates/by Gunjan VermaOn January 1, 2024, India’s CDSCO released a notice announcing the roll-out of the NSWS.