Medical Devices in Vietnam: Renewal, Variation, & Change Notification Process

Renewals, variations, and change notifications are the heartbeat of medical device post-approval compliance in Vietnam. Managing them effectively means fewer delays, smoother approvals, and uninterrupted access to one of Southeast Asia’s most dynamic healthcare markets.

Keep reading for a step-by-step guide to navigating Vietnam’s post-approval regulatory obligations — or get in touch with Cisema today for expert support from our Vietnam-based regulatory team.

Before we explore the update procedures in detail, it’s important to understand the foundation of Vietnam’s post-approval framework. This guide first clarifies the three main types of medical device updates — renewals, variations, and new registrations — then explains how each is handled under the Ministry of Health (MOH) system, followed by best practices to help you maintain long-term compliance.

Understanding Medical Device Renewals, Variations, and New Registrations in Vietnam

Every successful post-approval update begins with understanding the type of submission required. Vietnam’s post-approval system distinguishes between three main categories, each with its own purpose, scope, and documentation requirements:

1. Renewal – Extending or converting an existing registration
2. Variation – Reporting minor changes that do not affect safety or intended use
3. New Registration – Submitting a completely new dossier for significant changes

Knowing which applies avoids unnecessary administrative work and ensures continuous compliance.

Medical Device License Renewal in Vietnam

Building on the categories above, the first type of update — license renewal — applies when an existing registration must be extended or converted to comply with current regulations.

Under Decree No. 98/2021/NĐ-CP, most medical device registrations in Vietnam are now valid indefinitely once a medical device receives its circulation number (“số lưu hành”). This marks a major shift from the previous framework, where registrations had fixed expiration dates.

However, renewals may still be necessary in specific situations, including:

• Devices registered under Decree 36/2016 or Decree 169/2018
• Transitional or legacy import licenses issued before 2022
• Registrations with limited validity (e.g., emergency approvals)
• Products undergoing significant changes that cannot be addressed through minor notifications

Even when a formal renewal is not needed, administrative or technical updates must still be reported to the Ministry of Health (MOH) to maintain data accuracy.

Vietnam Medical Device Change Notification: Managing Minor Variations

If your update involves adjustments that don’t affect safety or intended use, a change notification detailing administrative or technical changes is typically sufficient. This process keeps your registration dossier accurate while avoiding the burden of a full re-registration.

Typical cases requiring a change notification include:

• Change of manufacturer or registration holder name or address
• Updates to labeling or Instructions for Use (IFU)
• Changes in packaging format or design
• Modifications to after-sales service or warranty provider
• Reduction in the number of manufacturers, models, or product codes

By submitting minor variations promptly, you maintain compliance without disrupting market access.

Vietnam MOH Requirements for Major Changes and New Registrations

Some updates are too significant for a notification. If a change affects safety, performance, or intended use, a new registration dossier must be submitted (see this guide on preparing a complete dossier for details). This ensures the Ministry of Health can properly assess the implications of the change.

You must submit a new registration if any of the following apply:

• Device intended use, indications, or performance have changed
• Product model, category, or code affects safety or clinical performance
• Change in the registration holder (license owner) where ownership transfer cannot be documented as a simple variation
• Manufacturing occurs at a new facility that alters production or quality control

In short, if the change affects how the device functions or is represented to users, re-registration is necessary.

Step-by-Step Guide to Updating a Medical Device Registration in Vietnam

With the distinctions between minor and major changes established, the next step is understanding how to manage updates in a structured, logical way. By viewing the process as a continuous workflow—from classification to implementation—you can ensure full compliance, minimize delays, and maintain uninterrupted market access.

Step 1: Identify the Correct Submission Type

The first and most critical step is determining the right type of submission for your update. Submitting under the wrong category can lead to delays or even rejection:

• A change notification (minor change) — update existing license.
• A new registration (major change) — submit a new application.

Taking time to categorize your change correctly ensures you follow the right procedural path from the start.

Step 2: Prepare All Required Supporting Documents

Once you know your submission type, the next step is assembling the documentation. A thorough preparation at this stage can dramatically reduce review time and prevent repeated requests from the MOH.

Common documents include:

• Cover letter explaining the change
• Copy of existing registration number
• Updated Certificate of Free Sale, ISO 13485, or CE/FDA certificate
• Revised label and IFU (in Vietnamese)
• Legal documents showing name/address change
• Power of Attorney and Authorization Letter (if submitted via a local agent)

Having a complete, well-organized dossier ensures a smoother review process while also demonstrating the company’s professionalism and readiness to comply with Vietnamese regulatory standards.

Step 3: Submit Your Application via the MOH IMDA Portal

With documentation complete, you move into the submission phase. Submit your application through the Infrastructure and Medical Device Administration (IMDA) portal.

Key points during submission:

• Select the appropriate procedure:
  • “Adjustment / Change Notification” (Điều chỉnh thông tin số lưu hành) for minor changes
  • “New Registration” (Cấp mới số lưu hành) for major changes
• Upload all required documents
• Pay any applicable fees
• Verify that all files are complete and correctly formatted

Careful attention at this stage prevents unnecessary delays caused by incomplete applications.

Step 4: Respond Promptly to MOH Requests

Submission is not the end of the process—review and communication follow. During the review process, the MOH may request clarifications or additional documentation.

To keep your application on track:

• Respond within the stated timeframe (usually 30 days)
• Ensure responses clearly address each query and attach any missing documents
• Coordinate with a local regulatory agent if applicable

Timely, organized communication ensures the MOH can complete its review efficiently and reduces the risk of your application being delayed or suspended.

Step 5: Receive and Implement the Updated Registration

Once approved, your updated registration certificate becomes available on the MOH portal.

At this stage:

• Confirm that all approved changes are accurately reflected
• Update product labels, packaging, and Instructions for Use (IFU) to match approved documents
• Notify internal teams and distributors to maintain compliance

Closing the loop on implementation ensures regulatory consistency across your supply chain and product documentation.

Best Practices for Managing Medical Device Updates in Vietnam

Completing the procedural steps is only part of maintaining compliance. The most successful companies build a proactive framework that anticipates changes, manages documentation effectively, and leverages local insight.

The following best practices reinforce and sustain the workflow described above.

Plan Strategically

Instead of reacting to changes as they arise, conduct regular, proactive reviews (ideally quarterly) of upcoming product modifications. This allows you to:

• Determine which updates require a minor variation versus a full re-registration
• Allocate resources efficiently
• Avoid bottlenecks in MOH review cycles

Strategic planning keeps updates orderly and ensures your team can respond quickly to new regulatory requirements.

Maintain Organized Documentation

Documentation management connects directly to the quality of submissions and the speed of approvals. Maintaining both Vietnamese and English versions of key certificates, labels, and IFUs is essential, while enforcing strict version control helps to:

• Minimize MOH queries and clarification requests
• Create a clear, reliable audit trail across your global operations

A clean, well-documented record system transforms compliance into a continuous, controlled process rather than a reactive one.

Leverage Local Regulatory Expertise

Finally, even the best internal systems benefit from external insight. Vietnam’s regulatory landscape is dynamic, and interpretations by the Department of Medical Equipment and Construction (DMEC) and IMDA can shift over time.

Partnering with a Vietnam-based regulatory expert ensures:

• Up-to-date alignment with current regulatory expectations
• Continuous monitoring of procedural changes and documentation formats
• Faster, more predictable outcomes through local familiarity and relationships.

This combination of foresight and local knowledge ties the entire workflow together, reducing regulatory risk with every submission.

Final Thoughts: Updating Medical Device Licenses in Vietnam

Renewals, variations, and change notifications in Vietnam are straightforward when approached with foresight and disciplined planning. The real difference between a smooth approval and a prolonged review often comes down to planning, maintaining precise documentation, and engaging the right local expertise.

Cisema’s Vietnam-based regulatory team supports manufacturers at every stage of this cycle — from initial registration to renewals and variations — by helping you:

• Classify each update correctly and prepare a fully compliant Vietnamese dossier
• Submit efficiently through the MOH IMDA portal and track application progress
• Respond promptly to MOH feedback

With the right guidance, Vietnam’s regulatory process becomes a manageable part of your product lifecycle. Get in touch with Cisema today to keep your devices compliant, approved, and continuously available on the Vietnamese market.

Further Information

• Explore Cisema’s MOH registration services in Vietnam
• Read Cisema’s complete guide to preparing dossiers for medical device registration in Vietnam

References

• Read the following Vietnamese Government medical device decrees:
  • Read Decree No. 98/2021/NĐ-CP – PRESCRIBING MEDICAL DEVICE MANAGEMENT
  • Read Decree No. 36/2016/NĐ-CP – RETURN MEDICAL EQUIPMENT MANAGEMENT
  • Read Decree No. 169/2018/NĐ-CP – Amendments to Decree 36/2016/NĐ-CP on Medical Device Management
• Visit the Infrastructure and Medical Device Administration (IMDA) Portal

Frequently Asked Questions:

Do medical device registrations in Vietnam expire?

Under Decree No. 98/2021/NĐ-CP, most medical device registrations are valid indefinitely once a circulation number is issued. However, devices registered under earlier decrees (Decree 36/2016 or Decree 169/2018) or transitional import licenses may still require renewal or conversion to comply with current regulations.

What is the difference between a minor and a major change?

Minor changes don’t affect safety or intended use, such as updates to labeling or manufacturer information. Major changes impact performance, intended use, or clinical safety, requiring a new registration.

How long does it take to process a Medical Device renewal or variation?

Minor variations typically take 1–2 months, while major changes usually take 1–3 months. Delays can occur if documents are incomplete or MOH requests additional information.

What documents are needed for a change notification or new registration?

Key documents include the cover letter, existing registration, updated certificates, revised labels/IFU, legal documents for ownership or address changes, and Power of Attorney if using a local agent.

How can I ensure a smooth submission process?

Plan product updates in advance (ideally on a quarterly basis), maintain both Vietnamese and English documentation, and work with an experienced Vietnam-based regulatory expert to stay aligned with evolving MOH requirements.