Powerful China CFS Fast Track in Vietnam for Faster Class C/D Medical Device Registration (2025)

In 2025, securing fast-track registration for Class C/D medical devices in Vietnam often relies on meeting the China CFS fast track requirements. A valid China-issued Certificate of Free Sale (CFS) can open the door to accelerated approval under Vietnam’s regulatory framework, helping manufacturers cut waiting times and reduce compliance costs. This pathway offers a competitive advantage for companies ready to enter Vietnam’s rapidly expanding medical device market, but it also demands meticulous preparation. From aligning your documentation with official dossier formats to avoiding common submission errors, every detail matters in determining whether your application moves quickly or stalls in review. This article explores how the China CFS fast track works, the eligibility rules you must meet, and practical tips to maximize your approval chances in 2025.

Fast-Track Eligibility Criteria for Class C/D Medical Device Registration in Vietnam

According to Decree 98/2021/NĐ-CP on the management of medical devices, obtaining a China-issued Certificate of Free Sale (CFS) from a recognized reference authority—most notably the National Medical Products Administration (NMPA)—can qualify your Class C/D medical device for fast-track registration in Vietnam.

From January 1, 2024, all Class C/D applications must strictly follow the ASEAN Common Submission Dossier Template (CSDT) format, which standardizes technical and administrative information. If your device has already received market approval in a reference country, and you hold a valid CFS from China’s NMPA, the Vietnam Ministry of Health will waive the technical evaluation step. This exemption can reduce the approval timeline from several months to just a few weeks, allowing faster market entry, lower regulatory costs, and a competitive advantage in Vietnam’s growing healthcare sector.

Additional Considerations for China CFS Holders Seeking Fast-Track Approval in Vietnam

In January 2025, Vietnam’s Ministry of Health officially became the IMDA (International Medical Device Administration), continuing to oversee the registration of Class C/D medical devices under Decree 98/2021 and its amendments. While the fast-track approval pathway is designed to accelerate market entry for devices with a valid China-issued CFS—particularly from the NMPA—applicants should be aware of potential processing delays.

Although regulations set a 30-working-day target for fast-track reviews, actual timelines are often much longer. Due to a high volume of submissions and limited review capacity, many Class C/D applications currently take 10 to 16 months to finalize. This backlog means that companies should plan ahead, ensure their CSDT dossiers are complete and error-free, and consider professional support to minimize delays and maintain their competitive advantage in Vietnam’s growing medical device market.

Common China CFS Documentation Errors That Delay Class C/D Device Registration

Errors in a China-issued CFS often lead to rejection or long delays for Class C/D medical device registration in Vietnam. Frequent problems include missing or inconsistent product names/models, unclear issuing authority (e.g., failure to identify NMPA), invalid official seals, and CFS statements that indicate “export only” rather than being freely sold in the domestic market. To qualify for fast-track review, submit a CFS that clearly names the product/model, identifies the issuing agency, bears an authorized seal, and explicitly confirms domestic free sale—plus certified translations and any supporting market-approval documents.

Conclusion – How to Maximize Your China CFS Fast Track Potential in 2025

A valid China-issued CFS from the NMPA is critical for securing fast-track approval of Class C/D medical devices in Vietnam in 2025. Ensure your CFS matches your CSDT dossier, with correct product details, issuing authority, and seal to avoid rejection. Green NRJ provides expert support in reviewing China CFS documents, preparing compliant ASEAN CSDT files, and navigating Vietnam’s fast-track process. Contact Green NRJ today to save time, cut costs, and achieve faster market access.