The process for applying for the registration of Class B medical devices in Malaysia is regulated by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737). The registration must be done through the MeDC@St (Medical Device Centralized Online System) portal. Below is a step-by-step guide on how to apply for the registration:

1. Classification of the Medical Device

Before proceeding with the registration, ensure that the device is classified correctly as Class B (low-to-moderate risk). Devices are categorized based on their risk to patients, users, or others. For accurate classification, refer to the Guidelines for the Classification of Medical Devices by the MDA or consult a regulatory expert.

2. Appoint a Local Authorized Representative (LAR)

• Foreign Manufacturers: If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) in Malaysia. The LAR will act on your behalf and handle the device registration process.
• The LAR must be based in Malaysia and hold a valid Good Distribution Practice for Medical Devices (GDPMD) certification.

3. Obtain GDPMD Certification (for importers/distributors)

• GDPMD Certification: If you are an importer or distributor, ensure you have a GDPMD certification to demonstrate compliance with the guidelines for storing, distributing, and handling medical devices in Malaysia.
• This certification is crucial for importers/distributors and is part of the pre-requisites for the registration process.

4. Prepare the Necessary Documents

Gather all required documentation that supports the safety, quality, and performance of the medical device. These documents should be prepared according to MDA guidelines and international standards. The required documents typically include:

• Technical Documentation:
  • Device description and intended use
  • Design and manufacturing process
  • Test reports on safety, performance, and biocompatibility
  • Validation reports for any applicable software
• Risk Management Report: Compliant with ISO 14971, detailing the risk analysis and mitigation measures.
• Clinical Evaluation Report (CER): Clinical data or clinical studies demonstrating the device's safety and performance.
• Labeling and Instructions for Use (IFU): Information provided on labels and packaging must comply with MDA regulations, including instructions for safe use and warnings.
• Quality Management System (QMS) Certification: Proof that the manufacturer follows ISO 13485 or an equivalent standard.
• Declaration of Conformity (DoC): A signed statement declaring that the device conforms to relevant standards and requirements.
• Post-Market Surveillance (PMS) Plan: A plan detailing how the safety and performance of the device will be monitored after it has been placed on the market.

5. Register on the MeDC@St Portal

• Create an Account: If you haven't already, create an account on the MeDC@St online registration portal (https://medcast.mda.gov.my/). You will need to register the manufacturer and/or LAR in the system.
• Profile Completion: Complete the necessary details in your account, such as the company profile, contact details, and LAR information (if applicable).

6. Submit the Application via MeDC@St

• Enter Device Information: Log in to the MeDC@St system and start the registration application by entering the medical device's details, classification, intended use, and any other requested information.
• Upload Required Documents: Upload all the technical, clinical, and supporting documentation that was prepared earlier.
• Review Submission: Before submitting, carefully review the application to ensure all details are accurate and complete.
• Pay the Registration Fee: Pay the required registration fee, which depends on the class of the device. The payment can be made through the MeDC@St portal.

7. MDA Review Process

• Preliminary Review: The MDA will perform an initial check of the application to ensure all required documents have been submitted correctly.
• Detailed Review: The MDA will conduct a technical evaluation of the submitted documents, including the device’s safety, performance, clinical data, risk management, and labeling.
• Requests for Additional Information: If there are gaps in the submission or additional clarifications are needed, the MDA will issue a request through the MeDC@St portal. You must respond promptly with the required information to avoid delays.

8. Issuance of Certificate of Registration

• Approval: Once the MDA has completed its review and is satisfied with the application, they will issue a Certificate of Registration.
• Validity: The certificate is typically valid for 5 years, and after that, re-registration is required to keep the device on the market.

9. Post-Registration Requirements

• Post-Market Surveillance (PMS): After the device is registered, you must comply with post-market obligations, including monitoring the device’s performance, reporting adverse events, and submitting updates to the MDA as needed.
• Vigilance and Adverse Event Reporting: You must have a system in place to report any adverse events or malfunctions to the MDA as part of the vigilance system.

10. Renewal and Updates

• Re-Registration: After 5 years, you must re-register the device by submitting updated documentation to the MDA.
• Periodic Updates: If there are any significant changes to the device, such as changes in manufacturing processes or intended use, these must be reported to the MDA.

Summary of the Steps:

1. Classify the device as Class B.
2. Appoint a Local Authorized Representative (LAR) if required.
3. Ensure GDPMD certification for importers and distributors.
4. Prepare and compile necessary technical, clinical, and QMS documents.
5. Register on the MeDC@St portal.
6. Submit the application and required documents.
7. Pay the registration fee.
8. Await MDA’s review and respond to any requests for additional information.
9. Receive the Certificate of Registration.
10. Comply with post-market obligations and re-register the device when required.

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