Thailand to Implement New Medical Device Classification System

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The Thai Food and Drug Administration (FDA) has announced its intentions to implement a risk-based medical and IVD device classification system toward harmonization with ASEAN MDD guidelines.

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4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

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US 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.

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THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

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With 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)

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ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

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Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.

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HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

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Hong 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.

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THAILAND SUSPENDS PLAN TO REGULATE HAND SANITIZER AS MEDICAL DEVICE

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In 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.

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CLIENT SUCCESS: ICECURE MEDICAL GROWS SALES IN ASIAN MARKETS

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Asia Actual assists IceCure in achieving goals for continued expansion in Asia

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MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMIC

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COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.

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