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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.
eRPS System: China National Medical Product Administration’s (NMPA) medical device registration system
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
Philippines Proposes New Fees for Medical Device Registration
The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.