D-class medical device registration with the Vietnam Ministry of Health (MOH) refers to the regulatory process for registering high-risk medical devices in Vietnam. In the context of Vietnam's medical device regulatory framework, medical devices are classified into four categories (Class A, B, C, and D) based on their potential risk to patients and users.

D-Class Medical Devices:

• Highest Risk: D-class devices are considered the highest-risk category. These devices are typically life-sustaining or life-supporting, or they could pose a significant risk if they fail or malfunction. They include critical medical devices such as implants, devices that support or sustain life (e.g., pacemakers, ventilators), and devices used for high-risk surgeries.

Key Features of D-Class Medical Devices:

1. High Risk to Patients: D-class devices have a high potential for harm if not used correctly or if they fail. These devices often involve direct interaction with the human body and have a critical impact on patient safety and health.

2. Regulatory Requirements: The registration process for D-class devices is more stringent compared to lower-risk devices (Class A, B, or C). It requires comprehensive documentation, including clinical data, risk management plans, quality management certifications, and sometimes an on-site inspection of the manufacturing facility.

3. Clinical Evaluation: For D-class devices, a clinical evaluation report (CER) is typically required. This report includes data from clinical trials or scientific literature to demonstrate that the device is safe and effective for its intended use.

4. Quality Management System (QMS): Manufacturers of D-class devices must demonstrate compliance with quality management standards such as ISO 13485, which governs the manufacturing and testing processes to ensure safety and effectiveness.

Regulatory Process:

• Registration with Vietnam MOH: The registration process with the Drug Administration of Vietnam (DAV) involves submitting a detailed application that includes:

  • Product description
  • Risk management documentation
  • Clinical and safety data
  • Manufacturing and quality certifications
  • Labeling and packaging details

• Review and Approval: The MOH will evaluate the submitted application and conduct a thorough review. This may include an on-site inspection of the manufacturing site to verify compliance with good manufacturing practices (GMP) and other regulatory standards.

• Post-Market Surveillance: After approval, manufacturers are required to monitor the device’s performance in the market, report any adverse events, and maintain compliance with Vietnam's medical device regulations.

Why Register D-Class Devices?

D-class devices must be registered to be legally marketed and sold in Vietnam. The registration ensures that the device meets all safety and efficacy standards set by the Vietnam Ministry of Health, which helps protect patients and healthcare providers from potentially harmful or ineffective medical devices.

In short, D-class medical device registration with the Vietnam MOH is a process to ensure that high-risk medical devices meet the stringent regulatory and safety standards required for use in the Vietnamese healthcare system. It involves submitting detailed documentation, undergoing a rigorous review process, and ensuring compliance with post-market surveillance requirements.

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