Process for Class A Medical Device MDA Registration in Malaysia

1. Device Classification:

   • Confirm that the device is classified as Class A under the Malaysian Medical Device Regulations. Class A devices are typically low-risk products like non-invasive devices (e.g., bandages, stethoscopes, thermometers).

2. Appoint a Local Authorized Representative (AR):

   • For foreign manufacturers: You must appoint a local Authorized Representative (AR) who is registered with the MDA to handle the application and communication with the authority.
   • For local manufacturers: You can apply directly without needing an AR.

3. Prepare Documentation:

   • Collect the required documentation for your application (see the "Required Documents" section below).

4. Register on MeDC@St (Online Portal):

   • Create an account on the MeDC@St portal https://medcast.mda.gov.my, which is the online platform for submitting the registration application to the MDA.
   • Fill in the application form with accurate details about your medical device.

5. Submit Documents and Application:

   • Upload the prepared documentation to the MeDC@St portal, ensuring all fields are filled correctly.

6. Pay the Registration Fee:

   • Submit the payment for the registration fee through the MeDC@St portal. The fee typically ranges from MYR 1,000 to MYR 3,000 (USD 200 to USD 650), depending on the type and specifics of the device.

7. MDA Review and Approval:

   • The MDA will review the application, and if everything is in order, the registration will be approved. Class A devices generally go through a quicker review process.
   • Upon approval, the MDA will issue a registration certificate allowing the device to be marketed in Malaysia.

8. Post-Market Surveillance:

   • After receiving the registration, the manufacturer (or AR) must ensure ongoing compliance with Malaysia’s post-market surveillance requirements, including adverse event reporting and quality control measures.

Required Documents for Class A Medical Device Registration

1. ISO 13485 Certification:

   • The manufacturer must have a valid ISO 13485 certification for the manufacturing facility, demonstrating compliance with quality management systems for medical devices.

2. Technical Documentation:

   • A technical file containing essential information on the device, including:
     • Device Description: Information on the device, its components, and its intended use.
     • Design and Manufacturing Details: Documentation about the manufacturing process and design specifications.
     • Safety and Performance Data: Information demonstrating the device’s safety, effectiveness, and performance.
     • Labeling and Instructions for Use: Clear and accurate labeling that complies with Malaysian regulations, including user instructions.

3. Declaration of Conformity:

   • A Declaration of Conformity, signed by the manufacturer or the authorized representative, stating that the device meets the necessary safety and regulatory requirements under the Medical Device Act 2012.

4. Local Authorized Representative (for foreign manufacturers):

   • Proof of the appointment of an Authorized Representative (AR) in Malaysia who will submit the application and manage communication with the MDA.

5. MeDC@St Online Registration Form:

   • Complete the application form available on the MeDC@St portal with all necessary device details.

Precautions to Take During the Registration Process

1. Accurate and Complete Documentation:

   • Ensure that all documentation is complete and accurate. Incomplete or incorrect information can lead to delays or rejection of the application.

2. Check Device Classification:

   • Confirm that your device is correctly classified as Class A. Misclassification can result in delays and additional scrutiny, as higher-risk devices require more detailed submissions.

3. Ensure Proper Labeling and Instructions:

   • Your device’s labeling and user instructions must meet Malaysian regulatory requirements. This includes language (typically in Malay or English) and clarity in providing safety information.

4. Authorized Representative:

   • If you are a foreign manufacturer, ensure that your Authorized Representative is officially registered with the MDA and can submit the application on your behalf.

5. Monitor MeDC@St for Updates:

   • Regularly check your account on the MeDC@St portal for any updates or additional requests from the MDA. The portal may request further documentation or clarification during the review process.

6. Compliance with Post-Market Obligations:

   • Once registered, ensure that your device continues to comply with post-market surveillance requirements, such as reporting adverse events and maintaining product quality standards.

7. Adherence to Timelines:

   • Be prepared for the review process to take up to 3 months. Ensure that all documents are submitted well in advance to avoid delays.

By following these steps carefully and ensuring you meet the MDA's requirements, you can successfully register your Class A medical device in Malaysia.

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