Medical Device Submission in Thai FDA: Our Recent Work in Suzhou, to support Medical Device Manufacturers
Over the past few days, we had the opportunity to participate in international events and train professionals on how to access the medical device market in Thailand. Alongside colleagues from Malaysia, Indonesia, China, Mexico, Brazil, and Saudi Arabia, we shared insights and strategies to help manufacturers navigate Thailand’s regulatory landscape. Below is a summary of the three main activities our Director, Diego Sala, took part in, which could significantly change how Chinese manufacturers—and other international players—approach Thailand, their largest market in Southeast Asia.
Day 1: Speech at the Suzhou Workshop: Medical Device Submission in Thai FDA
On August 26th, Diego Sala delivered a speech at the International Innovation in Medicine workshop in Suzhou, where he discussed the medical device submission in Thai FDA process. Specifically, he outlined how Chinese manufacturers can improve their documentation standards to streamline market access in Thailand. Thailand continues to be one of the most attractive destinations for medical devices, but to succeed, a more structured approach aligned with Thai regulatory expectations is essential. This could lead to a significant shift in how manufacturers, especially Chinese ones, view and engage with the Thai market.
Day 2: Interview with DIA Press Office
The second day was dedicated to an insightful interview with the DIA press office, where we discussed the opportunities and challenges manufacturers face in Thailand. We highlighted the importance of improving regulatory compliance and adapting local strategies while considering cultural and geopolitical differences. For manufacturers from China and other countries, understanding that the Thai market requires an approach beyond mere technical compliance is key to long-term success.
Day 3: Online Training for GO-Biz and Beijing Agency
On the third day, Diego Sala conducted an online training session for the California Governor’s Office of Business and Economic Development (GO-Biz), where he delved into the principles of medical device submission to Thai FDA, focusing on regulatory procedures and documentation standards. Later that day, a two-hour training session was delivered to our Beijing agency, providing them with a thorough overview of the Thai FDA submission process.
Key Takeaways from the Three-Day Journey
The three days of training, discussions, and presentations were a resounding success. They underscored the need for manufacturers from countries like China, Malaysia, Indonesia, Mexico, Brazil, and Saudi Arabia to improve their documentation standards as the first crucial step in navigating the registration process in Thailand. Additionally, we reiterated how critical it is to localize business strategies, considering the cultural and geopolitical differences of the Thai market. By adopting a more tailored approach, international manufacturers can more easily and successfully enter Thailand’s medical device market, the primary market in Southeast Asia.
On medical devices:
Khlong Song, Khlong Luang, Pathum Thani, 12120
