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INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES
Manufacturers 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
NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES
Asia 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.
Update: INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT
India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India.
4 Product Development Decisions that Impact Sales Performance in Asia
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.
THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS
The Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified.