Medical Device Conformity Assessment
(by way of verification)
Description:
- Why is Medical Device Conformity Assessment Important?
Under Section 10 of the Medical Device Act 2012 (Act 737), all medical devices intended for manufacture, import, or distribution in Malaysia must undergo conformity assessment by a registered Conformity Assessment Body (CAB) before registration. This ensures compliance with safety and performance standards to protect public health.
- Full Conformity Assessment
Medical devices without prior approval from recognized regulatory authorities or notified bodies must undergo full conformity assessment. This involves a comprehensive evaluation by a registered CAB, as required under Section 7(1)(a) of Act 737.
- Conformity Assessment by Way of Verification
Devices that have already been approved in recognized countries can follow a simplified assessment process. MDA Circular Letter No. 2/2014 provides policies that allow a faster registration process under Act 737 by verifying existing approvals instead of undergoing a full assessment.
- Latest Updates in 2025
As of January 15, 2025, the Medical Device (Compounding of Offenses) Regulations 2024 have been enforced. This regulation allows the Medical Device Authority (MDA) to compound specific regulatory offenses, ensuring stricter compliance with Act 737.
Additionally, the second edition of the Guidance Document: Importation of Medical Devices for Personal Use was released in January 2025. This update provides clearer guidelines for individuals importing medical devices for personal use, helping them navigate regulatory requirements effectively.
By adhering to the conformity assessment process, Malaysia continues to uphold high standards for medical devices, reinforcing patient safety and regulatory integrity.
Main Components:
The MDA’s medical device conformity assessment process involves several key components designed to assess the compliance of medical devices with regulatory requirements:
- Documentation Review:
The verification process begins with a thorough review of the technical documentation provided by the manufacturer or importer. This includes the device’s design, intended use, risk assessment, and compliance with relevant standards. - Conformity Assessment:
Depending on the class of the medical device, the MDA may require a conformity assessment, which could include an audit of the manufacturer’s quality management system or an evaluation of the device’s clinical data. - Testing and Inspection:
Medical devices may undergo testing and inspection to verify that they meet the specified performance criteria and safety standards. This ensures that the devices function as intended and do not pose any risk to users. - Labelling and Instructions for Use:
The MDA verifies that the labeling and instructions for use are clear, accurate, and compliant with regulatory requirements. This is crucial for ensuring that healthcare professionals and patients can use the device safely and effectively. - Post-Market Surveillance:
After a device is verified and allowed on the market, the MDA monitors its performance through post-market surveillance activities. This includes reporting and analyzing adverse events and conducting follow-up inspections.
Who should be certified:
Benefits:
- Enhanced Patient Safety: Mandatory product verification ensures that only safe and effective medical devices reach the market, reducing the risk of harm to patients.
- Increased Trust in Medical Devices: Verification by the MDA provides assurance to healthcare providers and patients that the medical devices they use meet the highest standards of quality and safety.
- Compliance with Regulatory Requirements: Manufacturers and importers benefit from a clear and structured process for demonstrating compliance with Malaysian regulatory requirements, facilitating smoother market access.
- Protection Against Substandard Products: The verification process helps to prevent substandard or counterfeit medical devices from entering the market, safeguarding public health and maintaining industry integrity.
Contributes to SDGs:
- SDG 3: Good Health and Well-being
- SDG 9: Industry, Innovation, and Infrastructure
- SDG 12: Responsible Consumption and Production
- SDG 16: Peace, Justice, and Strong Institutions
