Vietnam Medical Device Registration Overview: Timelines, Fees, & AR Strategy

Success in Vietnam medical device registration framework depends on understanding the regulatory process, fulfilling the formal requirements, and appointing the right Authorized Representative (AR). The framework, built around Decree No. 98/2021/ND-CP and overseen by the Ministry of Health (MOH) through the Infrastructure and Medical Device Administration (IMDA), provides a structured pathway for foreign manufacturers.

Keep reading for an overview of Vietnam’s medical device registration timelines, fees, and classification system, as well as the strategic advantages of partnering with an independent license holder like Cisema.

Appointing a Local Authorized Representative (AR)

The first step - and arguably the most important - is to appoint a Vietnam Authorized Representative. A foreign manufacturer cannot register devices directly with the IMDA (MOH); the AR is the legal entity that will hold the device registration and act as the official liaison.

The AR’s role covers:

• Submitting registration applications
• Managing post-market surveillance and incident reporting
• Responding to IMDA queries and maintaining compliance

Selecting an experienced, independent AR — such as Cisema — ensures a compliant, efficient process and safeguards your company’s regulatory independence in Vietnam.

Classification and Pathways

Once an AR is appointed, the next step is to determine the risk classification of your medical device. This classification dictates the type of application, dossier depth, and review level:

Impact on process:

• Class A, B → Simplified declaration procedure; no dossier review from the Authorities.
• Class C, D → Full dossier submission (CSDT format) required; IMDA review before approval.

Understanding your device’s classification early helps streamline dossier preparation and prevent costly rework.

Vietnam Medical Device Registration Process at a Glance

Once the AR is appointed and the classification pathway is clear, the process typically unfolds as follows:

1. Dossier Preparation - The AR compiles the application form and Technical Summary Documents or the Common Submission Dossier Template (CSDT) in Vietnamese.
2. Online Submission - The AR submits the application through the IMDA online portal.
3. MOH Review - The IMDA (MOH) reviews the application and may issue queries for clarification.
4. Approval & Listing - Approved devices are listed in the IMDA database.

A well-prepared dossier and prompt responses to IMDA queries are key to keeping approvals on schedule.

Vietnam Medical Device Registration Fees & Timelines

Government fees in Vietnam are paid per application and standardized according to device class, while timelines vary by review complexity and dossier quality

Tip: Having recognized agency approvals and a complete, well-organised dossier can help you stay on the shorter end of these timeline - Smart product grouping (e.g., Family, System) can significantly reduce the number of applications and lower costs.

Devices already approved by any of the following authorities may qualify for the Fast-Track Pathway, eliminating the need for a full CSDT review by IMDA.

Recognized agencies include:

• Therapeutic Goods Administration (TGA) - Australia.
• Health Canada - Canada.
• European Union member countries.
• Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) - Japan.
• U.S. Food and Drug Administration (FDA) - United States.
• Medicines and Healthcare products Regulatory Agency (MHRA) - United Kingdom.
• Switzerland.
• Ministry of Food & Drug Safety (MFDS) – Korea.
• National Medical Products Administration (NMPA) - China

This alignment with major global regulators helps shorten registration timelines and facilitate international market access.

Strategic Advantage: Independent License Holder

Beyond compliance, who holds your license determines your long-term flexibility in Vietnam. Partnering with an independent license holder such as Cisema—rather than a distributor-linked Authorized Representative—offers clear strategic benefits:

• Ownership of your registrations and technical documentation
• Flexibility to appoint or change distributors without re-registration
• Continuity of market access regardless of commercial changes
• Stronger control over compliance and long-term market strategy

This approach gives foreign manufacturers long-term flexibility, stronger control over compliance, and a more resilient market presence.

Final Thoughts

Vietnam provides a clear, internationally aligned framework for medical device registration. With the right Authorized Representative—ideally an independent license holder—and by leveraging reference agency approvals, market access can be achieved in as little as two months while maintaining full control over your commercial strategy.

If you are a medical device manufacturer seeking a trusted local Authorized Representative and expert support for medical device registration in Vietnam, get in touch with Cisema today.

Further Information

• Discover more about our medical device registration service in Vietnam.
• Read our complete guide to preparing a dossier for medical device registration in Vietnam for a detailed step-by-step overview of regulatory requirements.
• Learn about Vietnam’s Fast Track pathway for medical device registration to shorten approval timelines and accelerate access to the market.