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- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- 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
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INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES
/in India, Latest Updates/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
NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES
/in Latest Updates, 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.
THAI FDA ADDS ‘CONCISE EVALUATION’ FOR QUALIFYING MEDICAL AND IVD DEVICES
/in Latest Updates, Thailand/by Bryan GilburgUpdate: INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT
/in India, Latest Updates/by Bryan GilburgIndia’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.
INDONESIA ENFORCES MEDICAL DEVICE LABELING REQUIREMENTS
/in Indonesia, Latest Updates/by Bryan Gilburg4 Product Development Decisions that Impact Sales Performance in Asia
/in China, Hong Kong, India, Japan, Latest Updates, 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.
PHILIPPINES FDA CHANGES IMPLEMENTATION PLAN FOR NEW MEDICAL DEVICE REGULATIONS
/in Latest Updates, Philippines/by Bryan GilburgTHAILAND ELEVATES REGULATORY STATUS OF DERMAL FILLERS
/in Latest Updates, Thailand/by Bryan Gilburg