To register a Class A medical device with the Medical Device Authority (MDA) in Malaysia, you must follow a systematic process that ensures compliance with regulatory requirements. Below is a detailed overview of the process, required materials, and key points for registration.

1. Appointment of Local Authorized Representative (LAR)

• If the device is manufactured outside Malaysia, you must appoint a Local Authorized Representative (LAR) who is based in Malaysia. The LAR will be responsible for the submission and communication of the registration application with MDA.

2. Determine the Device Classification

• The device must be classified as Class A medical device based on MDA’s classification system. Class A devices are typically non-invasive, non-sterile, and pose a low risk to patients and users.

3. Prepare Required Materials/Documentation

The following documents are required for registering a Class A medical device with the MDA:

a. Device Documentation

• Product Information: Including the device name, model, intended use, and indications.
• Labeling: Proper labeling of the device, which should include:
  • Manufacturer’s name and contact information.
  • Device name, model, and product code.
  • Intended use and indications for use.
  • Instructions for use (IFU) in Bahasa Malaysia if applicable.
  • Manufacturer’s Certificate of Free Sale (CFS).

b. Compliance and Conformity Documentation

• Certificate of Free Sale (CFS): A document issued by the regulatory authority in the country of origin, confirming the device is legally sold in that country.
• Declaration of Conformity: A statement by the manufacturer (or authorized representative) confirming the device complies with relevant regulatory requirements such as ISO 13485 and other applicable standards (e.g., IEC 60601 for electrical devices).

c. Risk Assessment and Management

• A risk classification document outlining the device’s classification as Class A (low risk), as well as a risk management plan if required (particularly for more complex devices).

d. Good Manufacturing Practice (GMP) and Quality System

• For foreign manufacturers, proof of compliance with Good Manufacturing Practice (GMP) or relevant quality systems is necessary (e.g., ISO 13485 certification).

4. Register and Submit the Application via MDCAS Portal

• The registration must be done through the MDA’s Medical Device Centralized Application System (MDCAS) portal.
  • Create an account in the MDCAS system (if you do not already have one).
  • Log in to the portal and complete the registration form.
  • Upload the required documentation and product details.

5. Pay Registration Fees

• Fees: There is a non-refundable fee for registering a Class A medical device.
  • For local manufacturers: Approximately RM 500 to RM 1,000.
  • For foreign manufacturers (imported devices): Approximately RM 1,000 to RM 1,500.
• The fee is paid online via the MDCAS portal.

6. MDA Review and Evaluation

• After submission, MDA will evaluate the application and supporting documents. For Class A devices, this process is generally quicker than for higher-risk devices.
  • The evaluation will check for compliance with MDA regulations and may include verification of the documentation and conformity to applicable standards.
  • If MDA finds any issues with the submission, they may request additional information or clarifications.

7. Issuance of Registration Certificate

• Once MDA completes the evaluation and approves the application, they will issue a Medical Device Registration Certificate.
• The certificate allows the device to be marketed and sold in Malaysia.

8. Post-Market Surveillance

• After registration, manufacturers or their authorized representatives are required to maintain post-market surveillance to ensure the device’s continued safety and effectiveness in the Malaysian market.
• The MDA may request adverse event reports, product recalls, or compliance audits.

Key Points to Keep in Mind

• Timeliness: The registration process for Class A medical devices typically takes 2 to 3 months, but it can vary depending on the completeness of your submission and whether the MDA requests additional information.

• Compliance with Local Regulations: Ensure that the product labeling meets all MDA requirements, including the use of Bahasa Malaysia where required. Non-compliance with labeling requirements can delay the registration.

• Local Representation: Foreign manufacturers must appoint an authorized representative in Malaysia to handle the registration and communication with MDA.

• Documentation Accuracy: All documents submitted to the MDA must be accurate, complete, and in the required format. Incomplete or incorrect submissions will delay the approval process.

• Post-Market Obligations: The manufacturer or LAR must ensure that adverse events are reported to MDA and that the device continues to meet safety standards during its lifecycle.

Summary of Steps and Required Materials

1. Appoint Local Authorized Representative (if applicable).
2. Classify the device as Class A.
3. Prepare necessary documents:
   • Product Information, Labeling, and IFU.
   • Certificate of Free Sale (CFS).
   • Declaration of Conformity.
   • Risk Classification and Management documentation.
   • GMP or Quality System certification.
4. Submit application via MDCAS portal.
5. Pay registration fees.
6. MDA reviews and issues registration certificate.
7. Ensure post-market compliance and surveillance.

By following these steps and ensuring all materials are complete and accurate, you can successfully register a Class A medical device with the MDA in Malaysia.

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