The Class A medical device MDA registration process in Malaysia involves a series of steps to ensure that the device meets regulatory requirements for safety, performance, and quality. The Medical Device Authority (MDA) is responsible for overseeing the registration of medical devices in Malaysia under the Medical Device Act 2012. Below is the detailed step-by-step process for registering a Class A medical device with the MDA:

1. Pre-Registration Preparations

Before you begin the registration process, you should prepare the necessary documents and ensure that your medical device meets the required standards.

Preparatory Tasks:

• Ensure Compliance with Regulatory Standards: Ensure that your device complies with the relevant international standards such as ISO 13485 (Quality Management Systems) and ISO 14971 (Risk Management).
• Prepare Technical Documentation: Gather the required technical files for the device, including:
  • Device description
  • Intended use and indications
  • Risk management file (ISO 14971)
  • Design and manufacturing information
  • Test reports (safety and performance)
  • Labeling and instructions for use (IFU)
  • Declaration of Conformity
  • Certificate of free sale (if applicable)
  • ISO 13485 certification (if applicable)

2. Create an Account on MDA’s MDRS (Medical Device Registration System)

• MDA Registration System: The registration process is done through the MDA's Medical Device Registration System (MDRS), an online platform.
  • Account Creation: If you don’t already have an account, you need to create one on the MDRS portal.
  • Register as a User: Both manufacturers and their authorized representatives can register an account.
  • Login Credentials: Once registered, you will receive login credentials to access the system.

3. Assign an Authorized Representative (AR) (for Foreign Manufacturers)

• Local Authorized Representative: If you are a foreign manufacturer, you must designate a local Authorized Representative (AR) in Malaysia. This AR will handle the registration and ensure that the device complies with Malaysian regulations.
  • The AR will be responsible for ongoing regulatory obligations such as product monitoring and reporting.

4. Submit the Registration Application on MDRS

Required Information for Submission:

• Manufacturer Details: Provide the name, address, and contact information of the manufacturer.
• Authorized Representative (AR) Details: If applicable, provide the details of the AR.
• Device Details: Provide a description of the device, including its classification, intended use, and risk category.
• Device Category: Ensure that you select Class A as the classification.
• Compliance Evidence: Upload the necessary compliance documents, such as:
  • Risk management files
  • ISO 13485 certification
  • Device labeling
  • Technical file summary

Fee Payment:

• Pay the registration fee as specified by the MDA. The fees depend on the classification of the device and other factors.

5. MDA Evaluation and Review

Once the application is submitted, the MDA will begin the evaluation process. This includes:

• Document Review: The MDA reviews the submitted documentation to ensure that the device complies with Malaysian regulatory requirements.
  • Ensure that the technical documentation is complete, including risk assessments, clinical data (if required), and the manufacturer’s quality system certifications.
  • Quality Management System (QMS): If applicable, ensure the manufacturer has an ISO 13485-certified QMS in place.
• Assessment of Device Safety and Performance: The MDA may assess whether the device meets the necessary safety and performance standards set by the agency and international guidelines.

6. Approval and Issuance of Registration Certificate

If the MDA is satisfied with the application and documentation, they will approve the registration and issue the Medical Device Registration Certificate.

• Registration Certificate: The device will be registered in the MDA’s database, allowing it to be legally sold in Malaysia.
• Validity: The registration is typically valid for 5 years from the date of issuance.

7. Post-Registration Obligations

After the registration is granted, manufacturers and authorized representatives are required to adhere to ongoing obligations, including:

• Post-Market Surveillance (PMS): Monitor the safety and performance of the device in the market and report any adverse events.
• Periodic Updates: Submit any required updates, such as changes to the device, packaging, labeling, or manufacturing process.
• Renewal: Register the device again after 5 years through the renewal process.

Summary of Key Steps in the MDA Registration Process:

1. Pre-Registration Preparations: Ensure the device complies with international standards and prepare technical documentation.
2. Create MDRS Account: Register on the MDA Medical Device Registration System (MDRS).
3. Assign Authorized Representative (for foreign manufacturers): Ensure a local representative handles the registration process.
4. Submit the Registration Application: Provide necessary device details, documentation, and payment.
5. MDA Evaluation: MDA reviews the submission for compliance and safety.
6. Approval and Certificate Issuance: If successful, the device is registered, and a certificate is issued.
7. Post-Registration Obligations: Maintain post-market surveillance, update documents as necessary, and renew registration every 5 years.

By following these steps and adhering to the regulations, you can ensure that your Class A medical device is properly registered and compliant with Malaysian law, enabling its sale in the Malaysian market.

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