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4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA
/in China, Hong Kong, India, Japan, Latest News, Malaysia, Philippines, Russia, Singapore, South Korea, Thailand /by Bryan GilburgUS medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
THAI FDA ADDS ‘CONCISE EVALUATION’ FOR QUALIFYING MEDICAL AND IVD DEVICES
/in Latest News, Thailand /by Bryan GilburgNEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES
/in Latest News, Philippines /by Bryan GilburgAsia Actual is excited to announce the dedication of our new office space in the Philippines. The investment reflects the company’s commitment to the Philippines market and expectations for growth.
INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES
/in India, Latest News /by Bryan GilburgManufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate
PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS
/in Latest News, Philippines /by Bryan GilburgNew medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.
THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS
/in Latest News, Thailand /by Bryan GilburgWith Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)
HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION
/in Latest News, 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.
THAILAND SUSPENDS PLAN TO REGULATE HAND SANITIZER AS MEDICAL DEVICE
/in Latest News, 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.
THAI FDA ALLOWS SALES OF AT-HOME HIV TEST KITS
/in Latest News, 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.
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Asia Actual, LLC
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