Quick Asia Regulatory Updates

On 1 May 2025, Thailand’s Food and Drug Administration (TFDA) launched its new e-Certificate system. Certifications of all health products in Thailand are now online. The system aims to reduce some of the bureaucratic hurdles for manufacturers, importers, and distributors, with quicker, easier, and more secure paperless transactions. This system is part of the whole Digital Government Development plan for Thailand, retaining the e-Submission interface but now with components that make it more efficient and transparent. The move signifies the nation’s broader move towards a healthier economy through digitalization as well as becoming more competitive in global markets.

Vietnam issued Decree No. 102/2025/ND-CP (“Decree 102”) on May 13, 2025, to govern the management of digital medical information. The decree will come into effect on July 1, 2025, and is applicable to the development, use, protection, and management of digital medical data. Decree 102 has wide application, especially for foreign and domestic organizations that gather or process medical information in Vietnam, e.g., information regarding medical treatment and health insurance. Decree 102 has rigorous consent conditions for processing personal medical information. Such consent conditions can trump wider exemptions that are present under Vietnam’s Personal Data Protection Decree. Medical businesses with operations or activities in Vietnam will need to reform their compliance policies before the July 1 effective date.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.