EuroCham is proud to begin 2026 with a significant advocacy milestone, as our Medical Devices and Diagnostics Sector Committee (MDDSC) celebrates a major policy breakthrough on chemical regulation in Vietnam.
On 17 January 2026, the Government of Vietnam officially issued 4 Decrees and 2 Circulars to guide the implementation of the amended Law on Chemicals, completing a long-awaited regulatory framework that provides greater clarity, consistency, and legal certainty for businesses operating in Vietnam.
Why this matters for the medical device sector
Prior to these issuances, companies, particularly those in the medical device and healthcare product sectors, faced regulatory uncertainty due to unclear division of authority between the Ministry of Health (MOH) and the Ministry of Industry and Trade (MOIT). This created risks of overlapping regulatory requirements, inconsistent enforcement, and potential disruption to patient access to advanced healthcare technologies.
The new framework now formally:
- Confirms the Ministry of Health as the competent authority for chemicals used in medical devices and products under MOH management
- Clarifies regulatory responsibilities, reducing overlap between authorities
- Enhances legal predictability and consistency, supporting compliance planning
- Reduces administrative and supply-chain risks, while preserving chemical safety objectives
This outcome directly reflects key advocacy priorities raised by MDDSC, particularly the need for a clear, practical, and internationally aligned approach to chemical management in the healthcare sector.
What this means for EuroCham members
For EuroCham members operating in chemical-related and healthcare sectors, this milestone delivers tangible benefits:
- Greater regulatory clarity and predictability
- Lower compliance and administrative burden
- Reduced risk of overlapping inspections and approvals
- Stronger conditions for investment, innovation, and product availability
A milestone built on sustained advocacy
This achievement marks the culmination of structured advocacy efforts between 2024 and 2026, during which EuroCham and MDDSC:
- Submitted 6 formal advocacy letters to the Vietnam Chemicals Agency (MOIT), the Ministry of Health, the Ministry of Justice, the Office of the Government, and the National Assembly
- Contributed technical analyses and international best practices to support evidence-based policymaking
- Actively participated in more than ten policy consultations, conferences, and technical workshops organised by MOIT, MOH, and other relevant authorities
- Presented policy recommendations during the EU-ABC High-Level Delegation visit to Vietnam in November 2025, engaging directly with MOIT, Government representatives, and the National Assembly
EuroCham extends our sincere thanks to the MDDSC Board, its Regulatory Affairs Working Group, Government Affairs and Market Access Working Group, and all contributing member companies for their dedication and expertise.
As we move forward, EuroCham and MDDSC reaffirm our commitment to advancing policies that benefit European businesses while supporting Vietnam’s sustainable, innovation-driven growth, through constructive dialogue, technical cooperation, and long-term partnership. We look forward to building on this momentum in 2026.
Fact box: What was issued and what it covers
The newly promulgated legal instruments include:
Decrees:
- Decree No. 24/2026/ND-CP, stipulating the lists of chemicals subject to regulation under the Law on Chemicals;
- Decree No. 25/2026/ND-CP, detailing provisions and implementation measures for certain articles of the Law on Chemicals relating to the development of the chemical industry and chemical safety and security;
- Decree No. 26/2026/ND-CP, detailing and guiding the implementation of certain articles of the Law on Chemicals concerning the management of chemical activities and hazardous chemicals in products and goods;
- Decree No. 28/2026/ND-CP, stipulating the lists of narcotic substances and precursors.
Circulars:
- Circular No. 01/2026/TT-BCT, detailing and guiding the implementation of certain articles of the Law on Chemicals and Decree No. 26/2026/ND-CP;
- Circular No. 02/2026/TT-BCT, stipulating certain measures for the implementation of the Law on Chemicals and Decree No. 25/2026/ND-CP.
Together, these instruments complete the secondary legislation required to operationalise the amended Law on Chemicals.
