For Class B medical device registration with the Vietnam Ministry of Health (MOH), one of the key components of the application is the technical documentation, which provides detailed information about the product's design, performance, safety, and intended use.

This technical file must comply with the requirements set out in Decree 98/2021/ND-CP and supporting circulars (e.g., Circular 05/2022/TT-BYT).

📂 Technical Documentation Requirements (Class B Devices – Vietnam MOH)

Here’s what the technical dossier should typically include:

1. 📘 Product Description & Intended Use

• General description of the device

• Intended use or indication

• Target user (e.g., healthcare professionals, patients)

• Operating principles

2. 📊 Technical Specifications

• Model/variant names and numbers

• Key technical features and performance parameters

• Materials and components (especially those in contact with the body)

• Diagrams or photos (optional but helpful)

3. ⚙️ Device Design and Manufacturing Information

• Description of the design and manufacturing process

• Quality control procedures

• Manufacturing site(s) and responsibilities

4. 📋 Risk Management Summary

• Summary of the risk analysis in accordance with ISO 14971

• Description of measures taken to mitigate risks

• Risk/benefit assessment

5. 🧪 Test Reports / Performance Evaluation

• Performance test results (clinical or non-clinical as applicable)

• Biocompatibility, electrical safety, EMC, sterilization, etc., if relevant

• Clinical evidence (if required for your device type)

✅ Note: Not all Class B devices need clinical trials or data, but basic safety and performance testing is expected.

6. 🏷 Labeling & Packaging Information

• Labels in Vietnamese and original language

• Product box/package label

• Symbols and caution statements used on labeling

7. 📖 Instructions for Use (IFU) – in Vietnamese

• Must include:

  • Device description and intended use

  • Usage instructions

  • Contraindications and warnings

  • Storage and handling

  • AR contact info in Vietnam

8. 🏭 Manufacturer Information

• Name and address of manufacturer

• Contact details

• ISO 13485 certificate

🔍 Format and Language

✅ Optional but Recommended

• CE certificate, FDA approval, or other market authorizations

• Classification result from a licensed Vietnamese agency

📌 Summary Checklist

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