Avoid 3-Month Delays in Class C and D Medical Device Registration in Vietnam

Class C and D medical device registration in Vietnam can take longer than expected—often up to three months more—if your documentation is grouped incorrectly or does not comply with the Ministry of Health’s (MOH) requirements. Green NRJ helps you avoid these costly delays by guiding you through every step of the registration process, ensuring faster approvals and full compliance with Vietnamese regulations.

Why Registering Class C and D Medical Devices in Vietnam Is Challenging

Vietnam is one of the fastest-growing medical markets in Southeast Asia, but entering it requires a detailed understanding of the local regulatory system. Registering Class C and Class D medical devices in Vietnam is particularly complex due to their classification as high-risk. These devices are subject to rigorous Market Authorization requirements from the Ministry of Health (MOH) and the Department of Medical Equipment and Construction (DMEC).

Foreign manufacturers and distributors often encounter serious delays in medical device registration in Vietnam—usually due to grouping errors or legal gaps in their application. Understanding and meeting the MOH’s expectations is key to success.

Common Mistakes That Cause Delays

Vietnam’s regulations for medical device registration have become increasingly rigorous, especially for Class C and D devices, which are classified as high-risk. Although the regulatory framework is clearly outlined in Decree 98/2021/ND-CP, real-world application is subject to the interpretations of the MoH’s expert review councils.

1. Improper Product Grouping Is the Leading Cause of MOH Registration Rejection

A major—but often overlooked—cause of delay in Class C and D medical device registration in Vietnam is incorrect product grouping during dossier submission. Many applications that seem to be close to approval—even after 4 to 6 months of waiting—are suddenly returned with the comment: “Request to separate product groups.”

This rejection typically stems from:

• Products made from different materials, which do not qualify as variants of the same medical device family

• Devices intended for different anatomical locations or different clinical purposes, which violates the grouping rules outlined by the Ministry of Health Vietnam

In such cases, even a near-complete dossier must be restructured, with devices separated into different registration sets. This not only means additional documentation and translation, but also adds up to 3 months of waiting for each resubmission.

If not handled properly from the start, product grouping errors can derail your market entry strategy, resulting in lost time, increased costs, and delayed patient access.

2. Incorrect Classification of Medical Devices

Another major issue is incorrect classification of medical devices. Many foreign manufacturers mistakenly classify their Class C or Class D devices as Class A or B in the application dossier. Once submitted, the Ministry of Health (MOH) will reject the application, stating the classification is incorrect and requires a complete resubmission, causing at least 3 additional months of delay.

3. Invalid or Incomplete Legal Documents

Even with correct product grouping and classification, many applications for Class C and D medical device registration in Vietnam are still delayed due to missing or invalid documents. Some of the most common issues include:

• Missing Certificate of Free Sale (CFS)

• Expired ISO 13485 certification

• Absence of Vietnam-legalized documents or consular legalization

• Unclear or unsigned Letters of Authorization (LOA)

• Lack of required technical documentation or testing reports

When any of these documents are missing or outdated, the Ministry of Health (MOH) will either request resubmission or place the application on hold, costing companies an additional 2–3 months. Ensuring all required paperwork is complete and up to date is essential for fast-track medical device registration in Vietnam.

How to Avoid TGA-like Delays: Proactive Steps for Faster Market Authorization

To reduce the risk of product grouping rejection and ensure smooth Class C and D medical device registration in Vietnam, businesses should:

• Carefully analyze the product list to determine the most appropriate way to group devices based on structure, materials, and intended use. Avoid grouping items made from different materials or designed for different body areas.

• Name the medical device in accordance with Ministry of Health (MOH) guidelines. A clear and standardized name helps reviewers quickly verify conformity.

• Prepare a legally compliant dossier from the beginning, including all required documents, proper translations, and formatting to minimize the chance of additional requests or clarifications.

Taking these steps early in the process significantly increases your chances of securing timely market authorization and avoiding 3-month delays

What Green NRJ Does to Help You Avoid 3-Month Delays

If you’re preparing a medical device registration application — or waiting nervously for feedback from the Ministry of Health — you’re not alone. Many businesses face unexpected setbacks like product regrouping requests or incomplete dossiers, especially when registering Class C and D medical devices in Vietnam.

At Green NRJ, we help you avoid delays and secure your registration number faster by offering a complete, expert-led solution:

• Comprehensive dossier audit and optimization
  We thoroughly review your application to detect any errors in product grouping, classification, or technical documentation — the top reasons for rejection in Class C and D medical device registration in Vietnam.
• Professional preparation of the ASEAN CSDT
  Our team drafts or adjusts the Common Submission Dossier Template (CSDT) in line with ASEAN and Vietnamese regulations, customized to your device.
• All-in-one service – from dossier to decision
  We take care of everything: document standardization, translation, legal review, submission, follow-up, and response handling — until your medical device is fully registered in Vietnam.

Whether you’re submitting for the first time or have been asked to revise and resubmit, Green NRJ is your local partner for fast, compliant, and stress-free registration.

Conclusion

Need help with Class C and D medical device registration in Vietnam? Avoid costly delays caused by misclassification or incorrect product grouping. Green NRJ offers full-service support — from dossier review to submission and follow-up — ensuring your registration is accurate and on time.

👉 Contact Green NRJ today for a free consultation and find out how we can accelerate your product launch in Vietnam.