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.
The Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified.
China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster.
Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.
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