To register a Class A medical device with the Medical Device Authority (MDA) in Malaysia, certain conditions must be met to ensure compliance with the Medical Device Act 2012 and Medical Device Regulations 2012. These conditions are designed to guarantee the safety, quality, and performance of medical devices marketed in Malaysia.

Here are the key conditions that need to be met for Class A medical device MDA registration in Malaysia:

1. Device Classification

• The device must meet the criteria for Class A classification, which is typically for low-risk devices.
• Class A devices are usually non-invasive, low-risk devices such as simple bandages, surgical instruments like forceps, or basic diagnostic tools like thermometers. These devices generally do not come into contact with the body or only do so briefly and in a low-risk manner.
• Devices must be correctly classified under the Malaysian Medical Device Classification Rules, which are based on risk and intended use.

2. ISO 13485 Certification

• The manufacturer must have a valid ISO 13485 certification, which demonstrates the implementation of a quality management system (QMS) specifically for medical devices.
• ISO 13485 is crucial for ensuring that the manufacturing process meets international standards for safety, quality, and regulatory compliance.
• The certification must be obtained from a recognized certifying body. If the manufacturer is outside Malaysia, the local Authorized Representative (AR) can facilitate the registration process.

3. Appointment of Authorized Representative (AR) (For Foreign Manufacturers)

• Foreign manufacturers are required to appoint a local Authorized Representative (AR) in Malaysia. The AR acts as the point of contact with the MDA and is responsible for submitting the registration application and handling any regulatory matters.
• The AR must be a Malaysian entity registered with the MDA. They will need to provide documentation confirming their appointment by the foreign manufacturer.

4. Technical Documentation (Technical File)

• A technical file must be compiled, which includes comprehensive information about the device. This typically includes:
  • Device Description: Detailed information on the device, its intended use, materials, and components.
  • Manufacturing Process: Details about the design, development, and manufacturing process, including quality control procedures.
  • Safety and Performance Data: Evidence that the device complies with safety and performance standards, which could include lab test reports or compliance with international standards.
  • Labeling: A copy of the device’s labeling, which must comply with Malaysian regulations, including essential information like manufacturer details, instructions for use, and warnings.
  • Instructions for Use (IFU): Clear and accurate instructions for users, ensuring safe and effective use of the device.
  • Risk Management: A risk assessment document that shows how any potential risks associated with the device are controlled or mitigated.

5. Declaration of Conformity

• The manufacturer must submit a Declaration of Conformity to confirm that the device complies with the Medical Device Act 2012 and all relevant Malaysian regulations.
• For Class A devices, the Declaration of Conformity is typically self-declared by the manufacturer, indicating that the device meets the necessary safety and performance requirements.

6. Compliance with Labeling Requirements

• The labeling for the device must comply with MDA regulations, including:
  • The device’s name, model, and intended use.
  • Manufacturer’s name and address (or that of the Authorized Representative if foreign).
  • Warnings and precautions necessary for the safe use of the device.
  • The date of manufacture and expiry date, if applicable.
  • Instructions for use in both Malay and English.

7. Submission of Application via MeDC@St Portal

• All Class A medical device applications must be submitted through the MeDC@St portal, the official online registration system.
• The application must be complete, including all required documentation and payment for the registration fee.
• The application will be reviewed by the MDA, and if everything is in order, the registration will be approved.

8. Compliance with Post-Market Surveillance Requirements

• After registration, the manufacturer (or AR) must ensure ongoing compliance with post-market surveillance requirements, such as monitoring for adverse events or defective devices in the market.
• The manufacturer must also maintain quality control and report any device-related issues to the MDA.

9. Correct Classification of the Device

• The device must be correctly classified as Class A. Misclassification of the device can delay the registration process or result in rejection. It is important to verify that the device qualifies as a low-risk Class A device under the Malaysian regulations.

10. Compliance with Other Regulatory Requirements

• The device must comply with any additional regulatory requirements for specific types of devices (e.g., electrical safety for devices with electrical components, biocompatibility for devices that come into contact with the body).
• Specific standards (such as IEC 60601 for electrical medical devices) may be required depending on the nature of the device.

Summary of Conditions for Class A Medical Device Registration:

• ISO 13485 Certification for the manufacturer.
• Appointment of Authorized Representative (for foreign manufacturers).
• Technical documentation (including device description, manufacturing process, safety/performance data, and labeling).
• Declaration of Conformity stating compliance with Malaysian regulations.
• Correct device classification as Class A.
• Compliance with labeling and safety requirements under MDA regulations.
• Post-market surveillance obligations once the device is registered.

By ensuring all these conditions are met and submitting the required documents through the MeDC@St portal, you can register your Class A medical device in Malaysia efficiently.

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