On May 15, 2021, the VietNamese Ministry of Health (MOH) released new Guidance announcing Class B, C, and D devices will need to submit their applications in accordance with the ASEAN Common Submission Dossier Template (CSDT) format. The announcement goes into effect on January 2022 but the MOH has stated that they will begin accepting CSDT format ahead of time, greatly benefiting manufacturers that already have the CSDT documentation in order. Manufacturers will also need to show evidence of sufficient cybersecurity for products connected to the internet and all applications will need to be signed and stamped by a local license holder, like Asia Actual.

Leveraging Your CSDT Documentation

While the new process will require more documentation, allowing CSDT applications significantly benefits manufacturers with approvals in countries like Singapore and/or Malaysia (require CSDT). Manufacturers will also be able to submit most of their application in English (VietNamese also accepted) and will not need to submit VietNamese Technical Summaries and IFUs. Some IFUs may still need to be supplied in VietNamese, along with all devices still requiring a VietNamese sub-label. For the latest information on the VietNamese regulatory process, please see our Medical Device Registration page.

Outline of VietNam CSDT Table of Contents

1. Executive Summary

1. An overview (introductory descriptive information on the medical device, the intended uses and indications for use of the medical device, any novel features and a synopsis of the content of the CSDT);
2. Commercial marketing history;
3. Intended uses and indications in labelling;
4. List of regulatory approval or marketing clearance obtained;
5. Important safety/performance related information.

2. Essential Principles and Evidence of Conformity with Declaration of Conformity

3. Device Description

1. Device description & features
2. Intended Use
3. Indications
4. User Manual/Instructions for Use
5. Contraindications
6. Warnings
7. Precautions
8. Potential adverse effects
9. Alternative therapy
10. Materials (VietNamese or English)
11. Other Relevant Specifications
12. Other Descriptive Information

4. Summary of Design Verification and Validation Documents (English or VietNamese)

1. Pre-Clinical Studies
   1. Software verification and validation studies (if applicable)
   2. Medical equipment containing biological materials
2. Preclinical studies of in vitro reagents, calibrators, and control materials
   1. Analytical Performance
   2. Stability
3. Clinical Evidence
   1. Literature Review
   2. Clinical Experience Data (not from Clinical Studies)
   3. Clinical Studies

5. Device Labelling

1. Samples of Labels on the Device and its Packaging
2. User Manual/Instructions for Use

6. Risk Analysis (English or VietNamese)

7. Manufacturer Information (English or VietNamese)

Come Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Our commercialization experts can help you evaluate the VietNamese market and develop an optimal pricing strategy that can help you grow your sales in the 100-million-person market. Contact Asia Actual today with any questions or support requests.