As Southeast Asia's healthcare market continues to grow, Thailand and Vietnam present real opportunities for medical device manufacturers. Successfully entering these markets goes beyond regulatory approval. It requires an understanding of local regulations and active stakeholder engagement so your device reaches the right hands safely and compliantly.
Thailand and Vietnam are experiencing continued growth in healthcare investment and demand for medical technology. Vietnam's medical device market is forecast to grow from US$1.9 billion in 2024 to US$2.8 billion by 2029, with around 90% of medical equipment imported.
Thailand has strong demand for imported medical devices, with opportunities in areas including diagnostics, medical imaging, monitoring technologies and advanced healthcare solutions. In both markets, local regulatory knowledge and the right representation are essential to turn that opportunity into access.
Compliance Management Solutions acts as your Local Authorised Representative in both Thailand and Vietnam, from initial registration through to post-market surveillance and ongoing regulatory support.
Our services include
- Registration with the Thai FDA and the Vietnam Ministry of Health
- Vigilance, incident reporting and post-market surveillance
- Continuous regulatory updates and compliance guidance
- Legal representation and liaison with health authorities
- Strategic insight to support long term market growth
To discuss entry into Thailand or Vietnam, please contact our regulatory team.