Just before closing out the year, the Vietnamese Ministry of Health issued Circular 57/2025/TT-BYT on December 31, 2025. This critical document sets the stage for a new era in procurement, introducing detailed guidelines on classifying medical devices based on technical standards and quality.
Just before closing out the year, the Vietnamese Ministry of Health issued Circular 57/2025/TT-BYT on December 31, 2025. This critical document sets the stage for a new era in procurement, introducing detailed guidelines on classifying medical devices based on technical standards and quality.
While the Circular technically takes effect on February 15, 2026, full implementation for procurement applies from January 1, 2027. This gives manufacturers and distributors roughly one year to realign their strategies.
Here is an analysis of what this means for the market.
1. The Core Framework: The 6-Group Classification
The Circular categorizes medical devices into six distinct groups (Groups 1 through 6). The classification logic relies on two main pillars: Technical Standards and Country of Circulation.
- Groups 1, 3, & 5 (The “Reference” Tier): These groups are reserved for medical devices that meet the technical standards chosen by the procuring entity and are authorized for circulation in specific “reference countries/territories” (typically nations with stringent regulatory bodies).
- Groups 2, 4, & 6 (The “Non-reference” Tier): These include medical devices meeting technical standards that circulate in at least one country or territory outside the strict reference list.
The Domestic Advantage: A crucial provision in Article 3 states that medical devices manufactured in Vietnam are eligible to participate in all groups, provided they meet the technical and quality criteria.
2. The Strategic Pivot: The “Conformity” Clause
Perhaps the most analytical takeaway from Circular 57 is how it treats the Certificate of Conformity under Vietnamese regulations.
- For Local Manufacturers: Achieving this certification is a gateway to higher group classifications. It is a clear policy move to prioritize and facilitate the growth of Vietnam’s domestic medical device industry.
- For International Players: This creates a new barrier to entry for the top tiers. Foreign products wishing to compete in higher groups may now face the challenge of obtaining Vietnam-specific conformity certifications, rather than relying solely on international credentials.
3. Why the “Higher Group” Matters
While the Circular is new and specific implementation guidelines from the Ministry of Health (MoH) are still forthcoming, we can forecast several significant impacts for stakeholders who secure a spot in the higher groups (Groups 1 & 2):
🎯 Pricing Power: Higher classification generally correlates with a higher quality perception, potentially justifying higher ceiling prices in tender packages.
🎯 Bidding Versatility: A “cascading” eligibility is expected. For instance, if a major hospital allocates a 1 million USD budget with 70% reserved for Groups 1 & 2, devices in these top tiers can likely bid on those specific packages plus the lower-tier packages. Lower-tier devices cannot bid up.
🎯 Budget Allocation: Top-tier hospitals (Central and provincial levels) will likely allocate the lion’s share of their budget to higher-group devices to ensure quality.
🎯 Differentiation: This system naturally segments the market. High-tech, precision instruments will be funneled into higher groups, while general consumables and common devices may dominate the lower groups.
Key Dates to Watch
- Effective Date: February 15, 2026
- Mandatory Application Date: January 1, 2027
The Takeaway
Circular 57/2025/TT-BYT represents a push toward standardization and a significant boost for “Made in Vietnam” medical technology. For foreign manufacturers, the next 12 months will be critical for assessing regulatory strategies to ensure their devices remain competitive in high-value tenders.