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)
Tag Archive for: medical devices
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.
On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules
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.
In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.
Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.