To register a Class A medical device with the Medical Device Authority (MDA) in Malaysia, you need to follow a structured process. Below is a step-by-step guide on how to register for Class A medical device MDA registration:

1. Create an Account on the Medical Device Registration System (MDRS)

• Visit the MDRS Portal: Go to the official Medical Device Registration System (MDRS) website (www.mda.gov.my).
• Create an Account: If you do not already have an account, you must create one by providing necessary details like company name, contact information, and email address.
  • Local Manufacturers: Register as a local company.
  • Foreign Manufacturers: If you are a foreign manufacturer, you need to appoint a local Authorized Representative (AR) in Malaysia who will act on your behalf for the registration process.

2. Designate a Local Authorized Representative (for Foreign Manufacturers)

• Foreign Manufacturers must appoint a local Authorized Representative (AR) in Malaysia. This representative will handle the registration process, including submission, communication with MDA, and compliance.
• AR Requirements: The AR must be a registered entity with the MDA and must have the legal authority to represent the foreign manufacturer.

3. Prepare the Necessary Documentation

You will need to prepare several key documents that are required for the registration of a Class A medical device. The main documents typically include:

• Device Information: A description of the device, its intended use, and classification.
• Risk Management File: Documentation demonstrating the device meets safety requirements (ISO 14971).
• Quality Management System (QMS) Certificate: If applicable, provide proof of ISO 13485 certification or any other relevant QMS certification.
• Labeling and Instructions for Use (IFU): Ensure that the device labeling complies with the MDA’s requirements.
• Declaration of Conformity: A statement that confirms the device meets relevant regulations and standards.
• Performance and Safety Data: Any test reports demonstrating the safety and performance of the device (if applicable).
• Certificate of Free Sale: If the device is marketed in other countries, provide a certificate confirming it is freely sold in those markets (optional but may be helpful).
• Other Supporting Documents: Any additional documents based on the device’s classification.

4. Complete the Online Registration Form on MDRS

• Log in to the MDRS portal using your credentials.
• Complete the online registration form by entering details such as:
  • Manufacturer’s details.
  • Authorized Representative (if applicable) information.
  • Device details (name, description, intended use, and classification).
  • Declaration confirming that all documents are correct and complete.
• Upload Documents: Upload all the necessary documentation that supports your registration, such as the technical file, certificates, labeling, etc.

5. Pay the Registration Fee

• After completing the application, proceed to pay the registration fee.
  • The fee for Class A devices is usually lower compared to higher-risk devices, but you can verify the exact fee on the MDRS portal.
  • Payment is typically done online via credit card or bank transfer.

6. Submit the Application

• Once you have filled in the form and uploaded all required documents, click Submit to send the application to the MDA.
• After submission, the MDA will review the application to ensure compliance with regulatory requirements.

7. MDA Review and Evaluation

• Initial Review: The MDA will review the submitted application for completeness and to ensure that the device meets the necessary safety and performance standards.
• Evaluation of Documentation: The MDA will evaluate documents like the technical file, risk management documents, and quality management system certification.
• Clarifications (if necessary): If the MDA needs further information or clarification, they will request additional documents or details.

8. Approval and Issuance of Registration Certificate

• Once the MDA is satisfied with the documentation, they will issue a Medical Device Registration Certificate.
• The certificate typically remains valid for 5 years from the date of issuance.
• Approval Timeline: The approval process may take 4 to 8 weeks, depending on the complexity of the application and whether additional information is required.

9. Post-Registration Obligations

• Post-Market Surveillance: After receiving the registration certificate, you must monitor the device’s performance in the market and report any adverse events to the MDA.
• Renewal: The registration is valid for 5 years. You must apply for renewal before the registration expires to continue marketing the device.

Summary of Steps to Register Class A Medical Device in Malaysia:

1. Create an account on the MDA’s MDRS portal.
2. Designate an Authorized Representative (for foreign manufacturers).
3. Prepare the required documentation (technical file, risk management, labeling, ISO certificates, etc.).
4. Complete the registration form on the MDRS portal.
5. Pay the registration fee.
6. Submit the application to the MDA.
7. MDA review and approval (typically 4 to 8 weeks).
8. Receive the registration certificate.
9. Post-registration compliance (monitoring and renewal after 5 years).

By following these steps, you can successfully complete the Class A medical device registration with the MDA in Malaysia and ensure compliance with regulatory requirements.

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