For D-class medical device registration with the Vietnam Ministry of Health (MOH), you must submit a range of technical documents that demonstrate compliance with Vietnamese regulations. D-class devices are high-risk, so the documentation requirements are comprehensive and need to address various aspects of safety, performance, quality, and compliance. Here’s a detailed list of the technical document requirements for registering a D-class medical device in Vietnam:

1. Application Form (Registration Application)

• Description: A completed registration application form that provides basic details about the device, including the device's name, classification, manufacturer, local representative (if applicable), and intended use.
• Requirement: Signed by the local authorized representative in Vietnam.

2. Certificate of Free Sale (CFS)

• Description: The CFS certifies that the device is legally marketed and available for sale in the country of origin.
• Requirement: The certificate should be issued by the relevant health authority in the country where the device is manufactured, and it should be translated into Vietnamese.

3. Proof of Authorized Representative in Vietnam

• Description: Documentation showing that the foreign manufacturer has appointed a local authorized representative (e.g., distributor or importer) in Vietnam.
• Requirement: A legal agreement or contract with the local representative must be submitted.

4. GMP (Good Manufacturing Practice) Certificate

• Description: The manufacturer must submit a valid GMP certificate issued by the competent regulatory authority in the country of manufacture. The certificate verifies that the manufacturing facility follows proper quality management and manufacturing standards.
• Requirement: The GMP certificate should be translated into Vietnamese if not in English.

5. ISO 13485 Certificate

• Description: A valid ISO 13485 certificate demonstrating that the manufacturer has a compliant Quality Management System (QMS) for medical devices.
• Requirement: The ISO 13485 certificate should cover the design, production, and distribution of medical devices and must be recognized internationally.

6. Clinical Evaluation Report (CER)

• Description: As a D-class medical device, clinical data is crucial. You must provide a Clinical Evaluation Report (CER) based on clinical studies, trials, or post-market data to demonstrate the device’s safety and effectiveness.
• Requirement: If clinical trials have been conducted, the CER must include data from those trials. The CER should comply with Good Clinical Practice (GCP) standards.
• If the device has been marketed elsewhere, clinical data or post-market surveillance data from other regions (such as the EU, USA, or Japan) can be included.

7. Risk Management Report (ISO 14971 Compliance)

• Description: A risk management report is essential to demonstrate that risks associated with the device have been identified, evaluated, and mitigated.
• Requirement: The report should follow the guidelines of ISO 14971 and include a risk analysis and a risk control plan detailing how risks are mitigated during the design and manufacturing processes.

8. Technical File

• Description: A Technical File is a detailed set of documents that describes the device’s design, components, and performance characteristics.
• Required Documents:
  • Design and manufacturing specifications.
  • Device description and intended use.
  • Materials and components used in the device (including biological safety evaluations, if applicable).
  • Preclinical testing reports, such as biocompatibility testing and other performance evaluations (e.g., electrical safety, sterility).
  • User manual (Instructions for Use - IFU): The IFU must be in Vietnamese, detailing safe usage, indications, contraindications, warnings, and handling.

9. Labeling and Packaging Information

• Description: The labeling and packaging of the device must be compliant with Vietnamese regulations.
• Requirement: The labeling should include:
  • Device name.
  • Manufacturer’s name and address.
  • Intended use and indications.
  • Batch or serial number.
  • Expiry date (if applicable).
  • Warning or contraindications.
  • Storage conditions.
• Language: The labeling and IFU must be in Vietnamese or bilingual (Vietnamese and English).

10. Post-Market Surveillance Plan

• Description: A post-market surveillance (PMS) plan must be submitted to demonstrate that there will be a system in place to monitor the device’s performance and safety once it’s on the market.
• Requirement: The PMS plan should include:
  • Procedures for collecting adverse event reports.
  • Guidelines for product recalls if needed.
  • Reporting mechanisms for clinical feedback.

11. Declaration of Conformity

• Description: A Declaration of Conformity is a statement from the manufacturer that the device conforms to relevant safety, performance, and regulatory requirements. This is particularly important if the device is already certified in other regions like the EU (CE mark) or the USA (FDA approval).
• Requirement: The declaration should reference applicable standards (e.g., ISO 13485, ISO 14971) and certifications.

12. Import Permit (for Importers)

• Description: If the device will be imported to Vietnam, an import permit is required. The import permit ensures that the device complies with import regulations.
• Requirement: The local authorized representative or distributor in Vietnam will typically apply for the import permit.

Summary of Key Technical Document Requirements for D-Class Medical Device Registration with Vietnam MOH:

1. Registration application form.
2. Certificate of Free Sale (CFS).
3. Proof of Authorized Representative in Vietnam.
4. GMP certificate.
5. ISO 13485 certificate.
6. Clinical Evaluation Report (CER) with supporting clinical data.
7. Risk Management Report (ISO 14971 compliance).
8. Technical File (device description, materials, performance data, etc.).
9. Labeling and Packaging Information (Vietnamese language).
10. Post-market surveillance plan.
11. Declaration of Conformity.
12. Import Permit (for importers).

By preparing and submitting these technical documents in accordance with Vietnam's regulatory requirements, you can ensure a smoother and more efficient registration process for your D-class medical device.

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