To register a Class A medical device with the Medical Device Authority (MDA) in Malaysia, the process is relatively straightforward due to the lower risk profile of Class A devices. Below are the detailed procedures and steps:

1. Appoint a Local Authorized Representative (LAR) (If the manufacturer is outside Malaysia)

• If the device is manufactured outside Malaysia, the manufacturer must appoint a Local Authorized Representative (LAR) based in Malaysia. This representative is responsible for communicating with the MDA and ensuring compliance with regulations on behalf of the manufacturer.

2. Prepare Required Documentation

Gather and prepare all the necessary documents for submission:

• Certificate of Free Sale (CFS): This document verifies that the device is legally sold in the manufacturer’s country of origin.
• Product Information and Labeling: This includes detailed product specifications, labels, and instructions for use (IFU). The labeling must comply with MDA’s standards, including translations into Bahasa Malaysia if required.
• Risk Classification: For Class A, this confirms that the device is categorized as low-risk according to the MDA’s risk classification system.
• Declaration of Conformity: A declaration that the device meets relevant regulatory standards, including compliance with international standards (such as ISO 13485, IEC 60601, etc.).
• Other supporting documents: These could include clinical data, if necessary, though Class A devices generally require less data compared to higher-risk classifications.

3. Create an Account and Register with MDA

• Register with the MDA's MDCAS Portal: Visit the MDA’s official Medical Device Centralized Application System (MDCAS) or MDA e-RIS portal to create an account.
• Once registered, log in to the portal and provide information about your company (for local representatives) and the device you wish to register.

4. Submit Online Application

• Device Registration: In the MDCAS system, submit the required documents, including your device’s product details and supporting documents. Ensure all fields are completed accurately.
• Product Information: This will include device name, model, intended use, and classification as a Class A medical device.
• Manufacturer Information: If applicable, provide the manufacturer’s details, including their manufacturing site and regulatory compliance information.

5. Pay the Registration Fee

• After submission, you will be prompted to pay the registration fee. The fee is non-refundable and varies based on the device type and other factors. The payment can be made online via the MDCAS portal.

6. Review and Evaluation by MDA

• Once the application and fee are submitted, the MDA will evaluate the documentation. For Class A medical devices, the process is usually faster and does not involve an extensive review of clinical data or manufacturing facilities (compared to higher-risk classes).
• The MDA will check for the completeness and accuracy of your application, as well as verify that the device meets the regulatory requirements set by the authority.

7. MDA Approval and Registration

• If the application is complete and compliant with the regulations, the MDA will issue a Medical Device Registration Certificate. This certificate confirms that your Class A medical device is legally approved for sale in Malaysia.
• The registration will be valid for a certain period (usually 5 years), after which it may need to be renewed.

8. Post-Market Surveillance and Compliance

• Once the device is on the market, the manufacturer or LAR must ensure that the device continues to meet safety standards and monitor any adverse events.
• The MDA may conduct inspections or audits after the product is registered and available in the market to ensure ongoing compliance.

9. Labeling and Packaging Compliance

• Ensure that the device labeling complies with MDA guidelines, which require the inclusion of details such as the manufacturer's name, product name, intended use, and the registration number. The labeling should also include instructions in Bahasa Malaysia if applicable.

Key Points to Keep in Mind:

• Faster Approval: Class A devices typically undergo a quicker review process compared to higher-risk devices.
• Compliance: Be sure to stay compliant with local regulatory requirements, including labeling, adverse event reporting, and post-market surveillance.
• Local Representation: If the manufacturer is not based in Malaysia, the Local Authorized Representative plays a crucial role in communication and compliance with the MDA.

By following these steps and ensuring all documents and requirements are in order, you can successfully register your Class A medical device in Malaysia through the MDA.

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