Vietnam Decree 98 Update: Why 2026 Becomes the Golden Year for Chinese Class B Medical Devices

1. Overview of Decree 98/2021/ND-CP

Decree 98/2021/ND-CP, issued on 8 November 2021 and effective from 1 January 2022, significantly reformed Vietnam’s medical device registration framework. It reclassified many low-risk devices and introduced simplified pathways, particularly benefiting Class B (medium-low risk) products. Source: https://dione.vn/blogs/medical-devices/decree-no-98

The decree aligns Vietnam closer to international standards and reduces regulatory barriers for imported devices, especially from trusted markets like China.

2. Key Changes Affecting Class B Devices

Under Decree 98, Class B devices (previously often requiring full technical review) now qualify for abbreviated registration routes when supported by approvals from reference markets, including China’s NMPA. Major simplifications include:

• Waiver or reduction of local clinical trial requirements for many Class B devices with foreign approvals
• Exemption from on-site QMS audits for manufacturers with established quality systems recognized internationally
• Acceptance of technical documentation and conformity assessment already approved by NMPA Source: https://dione.vn/blogs/medical-devices/decree-no-98

These changes make Vietnam more accessible for Chinese manufacturers compared to pre-2022 requirements.

3. The 2026 Transition Window

A critical transitional provision in Decree 98 phases out older registration certificates and requires re-registration under the new rules. For many Class B devices, the key compliance deadline falls in 2026. From 2026 onward:

• Existing registrations expiring or needing renewal must follow the simplified Decree 98 pathway
• New Class B applications benefit fully from NMPA reliance without legacy complications
• The market opens widely to Chinese devices that were previously subject to more stringent local data requirements Source: https://dione.vn/blogs/medical-devices/decree-no-98

This creates a large number of re-registration opportunities and new entries concentrated in 2026.

4. Advantages for Chinese Manufacturers in 2026

Chinese Class B device manufacturers gain multiple strategic benefits in 2026:

• Fast-Track Registration: NMPA-approved devices can complete registration in months instead of years
• Cost Savings: Significant reduction in need for local clinical studies and Vietnam-specific audits
• Market Timing: 2026 aligns with the peak of re-registration wave, allowing simultaneous entry with many competitors
• Competitive Edge: Early movers can capture market share before full market saturation Source: https://dione.vn/blogs/medical-devices/decree-no-98

The combination of regulatory simplification and transitional deadlines makes 2026 exceptionally favorable.

5. Practical Steps for Chinese Companies

To capitalize on the 2026 opportunity, Chinese manufacturers should:

• Verify NMPA approval status and ensure documentation matches Vietnam requirements
• Appoint a local Authorized Representative early
• Prepare streamlined dossiers focusing on NMPA equivalence and local labelling
• Plan submissions to align with 2026 re-registration peak Source: https://dione.vn/blogs/medical-devices/decree-no-98

Early preparation ensures fastest possible market entry.

6. Strategic Implications

2026 is positioned as the “golden year” because:

• The transition deadline creates urgency and volume in registrations
• Decree 98’s NMPA reliance provisions become fully operational without legacy constraints
• Chinese manufacturers can leverage their home-market approvals for rapid expansion into Vietnam
• The market remains relatively unsaturated for many Class B categories Source: https://dione.vn/blogs/medical-devices/decree-no-98

This convergence of policy, timing, and regulatory alignment offers a rare window of opportunity.

7. Looking Ahead

While 2026 represents the peak opportunity under current rules, ongoing regulatory harmonization in ASEAN may further ease access. Chinese manufacturers who act decisively in 2026 can establish long-term presence ahead of potential future changes. Source: https://dione.vn/blogs/medical-devices/decree-no-98

Decree 98’s implementation makes 2026 a pivotal year for Chinese Class B medical devices in Vietnam.