To apply for the registration of a Class A medical device with the Medical Device Authority (MDA) in Malaysia, you must follow a specific process through the Medical Device Centralized Application System (MDCAS). Below are the detailed steps for applying for the registration and where to submit the application.

Steps to Apply for Class A Medical Device Registration with MDA

Step 1: Appointment of Local Authorized Representative (LAR)

• If the device is manufactured outside Malaysia, the manufacturer must appoint a Local Authorized Representative (LAR) who is based in Malaysia. The LAR will submit the registration application on behalf of the manufacturer and serve as the point of contact with MDA.

Step 2: Register for an Account on the MDCAS Portal

• Access the MDCAS Portal: The MDCAS portal is the official online system for submitting medical device registration applications to MDA. You can access the portal here: MDCAS Portal.
• Create an Account: If this is your first time applying, you will need to create an account on the MDCAS portal.
  • First-time users: Create a new account by providing company details and registering as either the manufacturer or the Local Authorized Representative (LAR).
  • Existing users: Log in with your existing account credentials.

Step 3: Prepare the Necessary Documents

Before submitting your application, ensure that all the required documents are prepared as per MDA's requirements. These include:

• Product Information (device name, intended use, classification).
• Labeling and Instructions for Use (IFU).
• Certificate of Free Sale (CFS) (for foreign manufacturers).
• Declaration of Conformity.
• Good Manufacturing Practice (GMP) or ISO 13485 certification (for foreign manufacturers).
• Risk Management Plan.
• Local Authorized Representative Appointment Letter (if applicable).
• Proof of Payment for registration fees.

Step 4: Log in to the MDCAS Portal

• Log into the MDCAS portal using your credentials.
• Select 'Device Registration': Once logged in, navigate to the device registration section of the portal.

Step 5: Complete the Registration Form

• Fill out the online application form, which includes:
  • Device Details: Product name, model number, intended use, classification, and other relevant details.
  • Manufacturer Information: For foreign manufacturers, provide the details of the manufacturer or their authorized representative.
  • Local Authorized Representative (LAR): If applicable, provide details of the LAR.

Step 6: Upload the Required Documents

• Upload all the necessary documents as per the requirements listed in Step 3. Ensure that:
  • All documents are clear, legible, and in the correct format (e.g., PDF).
  • The product labeling and IFU comply with MDA's regulations.
  • Declaration of Conformity is signed and dated by the manufacturer or the LAR.

Step 7: Pay the Registration Fees

• Pay the non-refundable registration fee through the MDCAS portal. The fee for registering a Class A medical device typically ranges from RM 500 to RM 1,000.
  • Payment is done via the portal using available online payment methods.

Step 8: Submit the Application

• Once the form is completed and documents are uploaded, click Submit to send the application to MDA for review.
• After submission, you will receive a confirmation email, and you can track the progress of your application through the MDCAS portal.

Step 9: MDA Review and Approval

• MDA will review your submission, including the documents and device details.
• For Class A medical devices, the review process is generally faster compared to higher-risk classifications. MDA will check for:
  • Compliance with medical device regulations.
  • Accuracy and completeness of the submitted documents.
• If MDA requires additional information, you will be notified, and you must respond within the stipulated time.

Step 10: Receive the Registration Certificate

• If the application is approved, MDA will issue a Medical Device Registration Certificate, which allows the device to be marketed and sold in Malaysia.
  • The certificate is typically valid for 5 years from the approval date.

Where to Submit the Application

• The registration application for Class A medical devices must be submitted via the MDCAS portal (Medical Device Centralized Application System). The portal is the official and only platform for the submission of applications to MDA.
  • MDCAS Portal: https://www.mdcas.mda.gov.my

Key Points to Remember

• Local Authorized Representative (LAR): If you are a foreign manufacturer, ensure that a Local Authorized Representative in Malaysia is appointed to handle the submission and act as the liaison with MDA.
• Documents: Ensure all documents are correctly formatted and comply with MDA’s regulations, particularly the labeling and IFU requirements.
• Payment: The registration fee is non-refundable, so ensure that you pay it only after reviewing all the details of your application.
• Tracking: You can track the progress of your application through the MDCAS portal after submission.

By following these steps and ensuring the completeness of your documents, you can successfully submit the application for registering a Class A medical device with MDA in Malaysia.

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