To register a Class A medical device with the Medical Device Authority (MDA) in Malaysia, there are specific regulatory requirements that must be met. These requirements ensure that the device meets the safety and performance standards before it is approved for sale in Malaysia. Below is a detailed list of the key requirements for registering a Class A medical device with the MDA:

1. Appointment of a Local Authorized Representative (LAR)

• If the device manufacturer is based outside of Malaysia, they must appoint a Local Authorized Representative (LAR) in Malaysia. The LAR will be responsible for submitting the registration application to the MDA and acting as the communication point between the manufacturer and MDA.

2. Device Classification

• The device must be classified as a Class A medical device according to MDA’s risk classification rules. Class A devices are considered to present the lowest risk to patients and users.
• Class A devices typically include non-invasive, non-sterile devices that are used in non-critical applications.

3. Certificate of Free Sale (CFS)

• The Certificate of Free Sale is required, which verifies that the medical device is legally marketed in the country of origin. This is especially needed for devices imported from abroad.
• The CFS must be issued by the relevant health or regulatory authority in the manufacturer’s country, confirming the device's compliance with local regulations.

4. Product Information and Labeling

• The device must have proper product labeling in accordance with MDA requirements. This includes details such as:
  • Device name and model.
  • Manufacturer’s details, including name and address.
  • Intended use and indications for use.
  • Instruction for use (IFU), which provides clear guidance on how the device should be used.
  • The labeling must also comply with Bahasa Malaysia requirements if the device is intended for use in Malaysia.

5. Declaration of Conformity

• The manufacturer or authorized representative must provide a Declaration of Conformity. This document states that the device meets the applicable regulatory standards, such as:
  • Compliance with ISO 13485 (Quality Management Systems for Medical Devices).
  • Compliance with international safety standards (e.g., IEC 60601 for electrical medical devices).
• The declaration must be signed by the manufacturer or their authorized representative.

6. Risk Management Documentation

• As part of the registration process, the manufacturer must demonstrate that the risk management processes are in place for the device. This may include:
  • Risk analysis and mitigation measures.
  • Post-market surveillance plans to monitor device performance after market entry.

7. Registration Application

• Submit the registration application through the MDA’s MDCAS (Medical Device Centralized Application System) or MDA e-RIS portal.
• The application should include:
  • All required documents (CFS, Declaration of Conformity, risk classification, product labeling, etc.).
  • Details of the device, including its intended use and classification as a Class A device.
  • Manufacturer’s information, including their compliance with relevant standards.
  • Any other supporting documentation as required by MDA.

8. Payment of Registration Fees

• The application requires payment of a non-refundable registration fee, which can be made via the MDCAS portal.
• Fees are generally based on the device type, classification, and other factors, so ensure the correct fee is paid to avoid delays.

9. Compliance with MDA Standards

• The device must comply with Malaysian Medical Device Regulations and MDA guidelines for marketing medical devices. This includes adherence to labeling, packaging, and other requirements specified by the MDA.
• Devices must also meet Good Manufacturing Practices (GMP), ISO standards, and other quality standards depending on the nature of the device.

10. Post-Market Surveillance

• After the device is registered and marketed in Malaysia, the manufacturer (or LAR) is responsible for monitoring the device’s performance.
• This includes reporting any adverse events or complaints to the MDA.
• Manufacturers must ensure ongoing compliance with the MDA’s post-market surveillance requirements.

Summary of Key Requirements:

1. Appointment of a Local Authorized Representative (LAR) (for non-Malaysian manufacturers).
2. Device classification as Class A medical device.
3. Certificate of Free Sale from the country of origin.
4. Product labeling and instructions for use compliant with MDA regulations.
5. Declaration of Conformity confirming compliance with relevant standards (e.g., ISO 13485, IEC 60601).
6. Risk management documentation and post-market surveillance plan.
7. Submission through MDA’s MDCAS portal, including payment of the registration fee.
8. Compliance with MDA regulations for medical devices and Good Manufacturing Practices (GMP).

By ensuring all these requirements are met, you can successfully register a Class A medical device with the MDA in Malaysia.

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