For D-class medical device registration with the Vietnam Ministry of Health (MOH), the device must meet several international and local standards and regulations to ensure its safety, effectiveness, and quality. These standards are aligned with global practices and aim to ensure the proper management of high-risk medical devices in the Vietnamese market. Below are the key standards and regulatory requirements for D-class medical devices:

1. ISO 13485 (Quality Management System)

• Standard: ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes.
• Purpose: The manufacturer must have a Quality Management System (QMS) in place that complies with ISO 13485. This standard ensures that the manufacturer adheres to strict quality control processes in the design, production, and distribution of medical devices.
• Application: This certification is mandatory for D-class devices and must be submitted as part of the registration process.

2. ISO 14971 (Risk Management)

• Standard: ISO 14971:2019 – Medical devices – Application of risk management to medical devices.
• Purpose: This standard requires the manufacturer to apply risk management principles to the design and manufacture of medical devices. For D-class devices, a thorough risk assessment must be conducted to identify, evaluate, and mitigate any potential risks associated with the device.
• Application: Manufacturers must provide a Risk Management Report to show compliance with this standard. This includes identifying potential hazards, assessing risks, and outlining how risks are mitigated.

3. Good Manufacturing Practice (GMP)

• Standard: GMP for medical devices as defined by the Vietnam MOH or International GMP standards.
• Purpose: Compliance with Good Manufacturing Practice (GMP) ensures that medical devices are consistently produced and controlled according to quality standards. D-class devices, being high-risk, are required to demonstrate strict adherence to GMP guidelines.
• Application: The GMP Certificate issued by the competent authority in the manufacturing country must be provided. If the manufacturing facility is in Vietnam, it should be accredited by the Vietnam MOH.

4. International Standards (IEC 60601 Series)

• Standard: IEC 60601 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
• Purpose: This is a set of international standards covering the safety and performance of medical electrical equipment, which is applicable to many high-risk medical devices, such as diagnostic equipment and surgical instruments.
• Application: Devices that involve electrical components must demonstrate compliance with these safety standards, including electrical safety and electromagnetic compatibility (EMC) testing.

5. Biocompatibility (ISO 10993)

• Standard: ISO 10993 – Biological evaluation of medical devices.
• Purpose: This standard provides guidelines for assessing the biological safety of medical devices, including their interaction with human tissue. It is crucial for devices that come into contact with the human body.
• Application: If the device has contact with the skin, mucous membranes, or internal organs, the manufacturer must submit biocompatibility test results as part of the registration process.

6. Clinical Evaluation (ISO 14155)

• Standard: ISO 14155:2020 – Clinical investigation of medical devices for human subjects – Good clinical practice.
• Purpose: Clinical evaluations are necessary to demonstrate the safety and effectiveness of the medical device. D-class medical devices often require clinical trials or clinical data to support the application.
• Application: For D-class devices, the manufacturer must provide a Clinical Evaluation Report (CER), which includes clinical trial data, post-market surveillance data, or data from other regulatory approvals (e.g., from the EU or FDA).

7. Labeling and Instruction for Use (IFU) Standards

• Standard: ISO 15223-1 – Medical devices – Symbols to be used with medical device labels, labeling, and IFU.
• Purpose: This standard defines the symbols and requirements for the labeling and instructions for use (IFU) of medical devices, ensuring that the end-user receives clear and accurate information on device usage.
• Application: The labeling must be compliant with Vietnamese regulations, including the use of Vietnamese language for the device’s name, usage instructions, warnings, and other relevant information.

8. ISO 13485:2016 – Regulatory Requirements

• Purpose: ISO 13485 is not just a QMS standard but also includes specific requirements for compliance with various regulatory bodies, including the Vietnam MOH. Manufacturers must ensure that their QMS complies with these regulatory standards, which are applicable to D-class devices.

9. Vietnam-Specific Regulatory Requirements

• Regulation: Circular 30/2015/TT-BYT – This regulation outlines the requirements for the registration of medical devices in Vietnam, including safety, effectiveness, clinical evaluation, and post-market surveillance.
• Purpose: The MOH in Vietnam requires that the registration process and technical documents comply with local laws and regulations for medical devices. The registration will also need to adhere to requirements that are specific to Vietnam and aligned with international standards.

10. Post-Market Surveillance and Reporting

• Standard: ISO 14155 – Clinical investigations and ISO 14971 for post-market monitoring.
• Purpose: Manufacturers must have a system in place for post-market surveillance to monitor the device’s performance in the market and report any adverse events or device failures.
• Application: D-class device manufacturers must submit a post-market surveillance plan, which is part of the registration process.

Summary of Key Standards for D-Class Medical Device Registration with Vietnam MOH:

1. ISO 13485 (Quality Management System)
2. ISO 14971 (Risk Management)
3. GMP Certification (Good Manufacturing Practice)
4. IEC 60601 (Safety of Medical Electrical Equipment)
5. ISO 10993 (Biocompatibility)
6. ISO 14155 (Clinical Evaluation and Trials)
7. ISO 15223-1 (Labeling and IFU)
8. Vietnam-Specific Regulations (Circular 30/2015/TT-BYT)
9. Post-Market Surveillance Standards (ISO 14155 and ISO 14971)

Conclusion:

D-class medical devices must comply with a range of international standards and Vietnam-specific regulations to ensure their safety, efficacy, and quality. Manufacturers should ensure that they meet these standards by providing comprehensive documentation and ensuring their products adhere to the required technical specifications.

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