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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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CLIENT SUCCESS: ICECURE MEDICAL GROWS SALES IN ASIAN MARKETS
/in Latest Updates, Thailand/by Bryan GilburgAsia Actual assists IceCure in achieving goals for continued expansion in Asia
Submission Changes in China: ToCs and the eRPS
/in China, Latest Updates/by Jena GillManufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
CHINA CHANGES CLINICAL DATA REQUIREMENTS FOR MEDICAL DEVICE REGISTRATION
/in China, Latest Updates/by Bryan GilburgThe changes to clinical data requirements will significantly decrease the regulatory burden for many medical device manufacturers seeking to access the Chinese market by eliminating the time and expense of conducting a local clinical trial.
Singapore Releases New Guidance of Medical Device Software
/in Latest Updates, Singapore/by Kenna RasiklalSingapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.
CHINA TAKES STEPS TO ENSURE QUALITY OF COVID-19 RELATED EXPORTS
/in China, Latest Updates/by Bryan GilburgChinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.
GUIDANCE ISSUED FOR IMPORTING UNREGISTERED MEDICAL DEVICES INTO KOREA
/in Latest Updates, South Korea/by Bryan GilburgKorea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products.
THAI FDA ALLOWS SALES OF AT-HOME HIV TEST KITS
/in Latest Updates, Thailand/by Bryan GilburgThe Thai government has voiced their commitment to ending the epidemic by supporting preventative awareness, access to cost-effective tests and treatment resources through public investment and/or private partnerships.
THAILAND SUSPENDS PLAN TO REGULATE HAND SANITIZER AS MEDICAL DEVICE
/in Latest Updates, Thailand/by Bryan GilburgIn the wake of the COVID-19 outbreak, the Thai FDA announced on March 5, 2020 that they will cancel their plans to begin regulating alcohol gel sanitizers as medical devices.