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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 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.
INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES
/in India, Latest Updates/by Bryan GilburgOn February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules
HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION
/in Latest Updates, Thailand/by Bryan GilburgHong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.
CHINA ENCOURAGES LOCAL MANUFACTURING OF FOREIGN MEDICAL DEVICES
/in China, Latest Updates/by Bryan GilburgChina has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster.