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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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TROUBLESHOOTING U.S. HOSPITAL SALES RESULTS
/in Commercial Services, Latest Updates, United States/by Mark WeisbrodMedical device manufacturers looking to establish or improve sales in the US market should contact our team for market insight and strategy development.
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.