Vietnam MoH Reduces Medical Device Registration Fees by 50% Through 2026

Vietnam’s Ministry of Health (MoH) has officially announced a temporary 50% reduction in government fees for medical device registration and licensing activities. As per Notice No. 645/TB-HTTB dated July 2, 2025, this fee cut—effective from July 1, 2025 to December 31, 2026—applies to new applications for circulation numbers, import/export licenses, testing certificates, and declarations of eligibility. This update is significant for companies navigating Vietnam medical device registration processes or entering the ASEAN medical device market.

Key Changes Under MoH Notice No. 645/TB-HTTB

The MoH has outlined specific reductions for various registration activities:

These new fees represent a 50% discount, offering cost relief to manufacturers and importers during the implementation period.

What Activities Are Eligible?

This temporary reduction applies to new applications submitted on or after July 1, 2025, and includes:

• Medical device circulation number registrations

• Import/export license applications

• Testing registration certificates

• Declarations of eligibility for manufacturing/distribution

Important: Dossiers submitted before July 1, 2025, are not eligible for retroactive adjustments or refunds.

Impact on Regulatory Strategy

This fee reduction aligns with the government’s broader initiative to ease regulatory burdens, especially for SMEs and startups. Companies planning market entry into Vietnam or expanding their ASEAN presence should consider accelerating their submissions to take advantage of this cost benefit.

Action Steps for Manufacturers

1. Review your product classification (A, B, C, or D).

2. Prepare and submit applications on or after July 1, 2025, to qualify.

3. Coordinate with your Vietnam-based regulatory consultants to ensure dossiers are submitted correctly under the new fee regime.

4. Track all official MoH updates for further regulatory changes through 2026.

For detailed information, the official Notice No. 645/TB-HTTB can be accessed on the Ministry of Health’s website: View Official MoH Notice No. 645/TB-HTTB (Vietnamese).

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