在医疗器械产品合法引入泰国市场之前，需要在Thai FDA进行注册。当地的主要法规为Medical Device Act B.E. 2551 (2008)和Medical Device Act (2nd Edition) B.E. 2562 (2019) 等。另外作为东盟ASEAN成员国，泰国也会参考东盟相关法规。境外制造商首先需要在泰国指定授权当地代理人。注册证有效期为5年，会颁发给该...
-Thailand Registration Introduction -THAILAND: Ministry of Public Health Announces Draft regarding Medical Device Definitions for Risk-based Classification References: Ministry of Public Health Announces the Draft regarding Rules, Procedures and Conditions in Preparing Academic Documents and Information Ensuring ...
At Siam Trade Development, we provide a wide range of Regulatory Services and Project Management for Healthcare Products in Thailand.We can register your products in Thai FDA under your Thai Company name or be your appointed License Holders and manage the market entry for you.In case you want ...
LifeSemantics will sign a memorandum of understanding with Rama 9 Hospital to use Dr.Call Thai by March. In addition, the company plans to supply Dr. Call Tie to 100 local medical institutions in the next three years. "Thailand's digital healthcare market valued at 1.4 trillion won ($1.05...
Regulatory services and license holding in Thailand for investors and foreign companies. Thai FDA registration, MLM license, fulfillment