To apply for Class A medical device registration with the Medical Device Authority (MDA) in Malaysia, you must follow a structured process through the MeDC@St portal. Here are the key steps and the application procedure:

Steps to Apply for Class A Medical Device MDA Registration in Malaysia:

1. Create an Account on MeDC@St Portal:

   • MeDC@St is the official online platform used for medical device registration in Malaysia.
   • Visit the MeDC@St portal at https://medcast.mda.gov.my to create an account.
   • Complete the registration process and login to access the application system.

2. Appoint an Authorized Representative (AR) (For Foreign Manufacturers):

   • If you are a foreign manufacturer, you must appoint a local Authorized Representative (AR) in Malaysia who will submit the application on your behalf and serve as a point of contact with the MDA.
   • For local manufacturers, you can apply directly without the need for an AR.

3. Prepare and Submit Required Documents:

   • Ensure that you have all the required documentation for your Class A device. These may include:
     • ISO 13485 Certification: Proof of your facility’s compliance with quality management standards for medical devices.
     • Technical Documentation: Including the device description, manufacturing details, performance data, and labeling.
     • Declaration of Conformity: A statement confirming that your device complies with Malaysian regulatory standards.
     • Appointment Letter of AR (if applicable).
   • Complete the online application and upload these documents on the MeDC@St portal.

4. Submit the Application and Pay Fees:

   • Once your documents are uploaded and the application is complete, pay the registration fee through the portal. The fee for Class A devices is typically MYR 1,000 to MYR 3,000 (USD 200 to USD 650).

5. Await MDA Review:

   • The MDA will review your application and supporting documents. If everything is in order, the registration will be approved.
   • The approval process for Class A devices is generally faster than for higher-risk classes.

6. Receive Registration Certificate:

   • Once approved, you will receive a Medical Device Registration Certificate, allowing you to legally market your device in Malaysia.

Where to Apply:

• The application for Class A medical device registration is done through the MeDC@St portal, which is accessible online. This is the official platform provided by the Medical Device Authority (MDA) of Malaysia for all medical device registrations.

Important Points:

• Make sure your documentation is complete and accurate to avoid delays. Incomplete applications can lead to rejections or prolonged review times.
• If you're a foreign manufacturer, ensure that your Authorized Representative is properly registered with the MDA.

By following these steps and ensuring that all your documents are in compliance with the MDA's regulations, you can successfully register your Class A medical device in Malaysia.

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