To apply for the registration of a Class A medical device with the Medical Device Authority (MDA) in Malaysia, you must use the Medical Device Centralized Application System (MDCAS). This is the official online portal for the submission of medical device registration applications.

Steps to Apply for Registration:

1. Access the MDCAS Portal:

   • The registration process begins at the MDCAS Portal, which is the online system provided by MDA for all medical device registrations.
   • You can access the portal here: MDCAS Portal.

2. Create an Account (for First-Time Users):

   • If your company does not already have an account, you will need to create one. This account will allow you to submit applications, track the status of your registration, and communicate with the MDA.
   • Register as either a manufacturer or an authorized representative (if you are not the manufacturer).

3. Log In to MDCAS:

   • After creating an account, log in to the portal using your username and password.

4. Fill Out the Application Form:

   • Complete the application form for Class A medical devices. This will include providing information such as:
     • Device details (e.g., name, type, and classification).
     • Manufacturer’s details (or details of the local authorized representative).
     • Risk classification and other relevant product documentation.

5. Submit Supporting Documents:

   • Upload all required documents, such as:
     • Certificate of Free Sale from the country of origin.
     • Product labeling and Instructions for Use (IFU).
     • Declaration of Conformity.
     • Risk classification and other supporting documents.

6. Pay the Registration Fee:

   • Once you’ve completed the form and uploaded all necessary documents, you will be required to pay the non-refundable registration fee. The fee can be paid online through the MDCAS portal.

7. Submit the Application:

   • After payment, submit the application. The MDA will then review your application.

Other Options for Assistance:

• If the manufacturer is located outside Malaysia, they must appoint a Local Authorized Representative (LAR), who will submit the application on their behalf and communicate with the MDA.
• If you need assistance navigating the MDCAS system or preparing the documentation, you may consider hiring a regulatory consultant or firm that specializes in medical device registration in Malaysia.

Important Notes:

• Ensure that your application and documentation are complete and compliant with MDA guidelines to avoid delays.
• The MDCAS system also provides tracking features so you can monitor the status of your application after submission.

By following these steps, you can apply for the registration of a Class A medical device in Malaysia through the official MDA portal.

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