Before applying for the registration of a Class A medical device with the Medical Device Authority (MDA) in Malaysia, thorough preparatory work is essential to ensure that the device meets all the necessary regulatory, technical, and documentation requirements. Here are the key steps and preparatory work to consider before starting the registration process:

1. Understand the Classification of the Device

• Confirm the Classification: Class A devices are considered low-risk, but it is important to verify that your device is correctly classified under Class A by MDA based on its intended use and risk profile. MDA has clear guidelines on the classification of medical devices, and you should ensure that the device falls under the Class A category before proceeding with registration.

2. Ensure Compliance with Relevant Regulations

• Familiarize Yourself with the Medical Device Act (Act 737) and Regulations: Review Malaysia's Medical Device Act 2012 and the Medical Device Regulations 2012 to ensure you are aware of the compliance requirements for your device. These regulations outline the registration process, technical requirements, labeling, and post-market surveillance.

• Know the ISO Standards: For Class A devices, the key international standards include:

  • ISO 13485:2016 (Quality Management System for medical devices)
  • ISO 14971:2019 (Risk management for medical devices)
  • ISO 15223-1:2016 (Symbols for medical device labels)
  • ISO 10993 (Biological evaluation of medical devices)

• Ensure that your device meets these standards if applicable.

3. Establish a Local Authorized Representative (LAR)

• Designate an Authorized Representative: If the manufacturer is located outside Malaysia, you must appoint a Local Authorized Representative (LAR) in Malaysia. The LAR will serve as the official point of contact for MDA and will handle regulatory matters on behalf of the manufacturer.
• Ensure that the LAR is familiar with MDA requirements and is capable of handling all communications related to the registration process.

4. Prepare the Device's Technical Documentation

• Technical File: Prepare a Technical File containing all the necessary documentation to demonstrate the device's safety and performance. This file should include, at a minimum:
  • Device description and intended use: Clear description of the device, its intended use, and the target population.
  • Design and manufacturing information: Details on the design, materials, and manufacturing processes used in the production of the device.
  • Risk management documentation: Results of the risk analysis (ISO 14971) to ensure that the device is safe for use.
  • Compliance with relevant standards: Evidence of compliance with international and local standards (such as ISO 13485).
  • Clinical data (if applicable): If the device claims to have clinical benefits, provide supporting clinical data or studies. Although Class A devices generally do not require clinical data, this may be necessary for devices with certain claims.
  • Instructions for Use (IFU): Detailed and clear IFU in Bahasa Malaysia and/or English, including warnings, contraindications, and safety precautions.
  • Labeling: Compliant device labeling that meets MDA’s labeling requirements, including appropriate symbols and regulatory information.

5. Ensure Manufacturing Site Compliance

• Manufacturing Site Requirements: Ensure that the manufacturing site complies with Good Manufacturing Practices (GMP) and that the quality control processes are in place. This includes ensuring that the manufacturing facility follows ISO 13485 for medical device manufacturing.
• If applicable, ensure that any third-party testing laboratories (for biocompatibility or performance testing) are accredited and meet the required standards.

6. Prepare for the Submission of Application

• Online Application via MDA’s MeDC@St: Familiarize yourself with the MeDC@St (Medical Device Centralized Application System), which is the online system for submitting applications to MDA. You need to create an account on this platform before submitting the application for Class A registration.

• Required Application Forms: Complete all required application forms on the MeDC@St portal. These will typically include:

  • General information about the manufacturer and device.
  • Local Authorized Representative (LAR) information (if applicable).
  • Product-specific details such as classification, intended use, and device description.

7. Prepare for Fee Payment

• Registration Fees: While registration for Class A devices is relatively inexpensive compared to higher-risk devices, you should be aware of the MDA registration fees. Ensure you have the necessary funds to make the payment for the submission.

8. Prepare Post-Market Surveillance Plan

• Post-Market Surveillance (PMS) Plan: Even for low-risk Class A devices, MDA expects manufacturers to have a PMS plan in place. This plan should outline how you will monitor the device’s performance and safety after it enters the market. You should be prepared to report any adverse events or safety issues to MDA if they occur post-market.

9. Labeling and Instruction for Use (IFU)

• Develop and Review the Labeling: Review the requirements for labeling to ensure that all required information is included, such as the device name, intended use, warnings, and contraindications. Labels should be in Bahasa Malaysia and/or English, depending on the market requirements.
• Instructions for Use (IFU): The IFU should be prepared in clear and understandable language. It must include details about device handling, storage, and specific usage guidelines.

10. Review and Finalize Documentation

• Review All Documents: Before submitting the application, thoroughly review all prepared documents to ensure they are complete and compliant with MDA’s guidelines. Any missing or incorrect information may delay the approval process.
• Consult with Experts (if necessary): If you're unsure about any aspect of the documentation, consider consulting with regulatory affairs professionals or specialists in medical device registration to ensure everything is in order.

Summary of Preparatory Work Before Applying for Registration:

1. Confirm Device Classification: Ensure the device qualifies as a Class A medical device under MDA regulations.
2. Understand Regulatory Requirements: Review the Medical Device Act 2012, regulations, and relevant international standards (e.g., ISO 13485, ISO 14971).
3. Appoint a Local Authorized Representative (LAR) (if applicable).
4. Prepare Technical Documentation: Compile the necessary documents, including device description, risk management, clinical data (if applicable), labeling, and Instructions for Use (IFU).
5. Ensure Compliance with Manufacturing Standards: Verify compliance with GMP and ISO standards in the manufacturing process.
6. Create a MeDC@St Account and familiarize yourself with the online registration portal.
7. Complete Application Forms: Fill out all required forms for submission to MDA.
8. Prepare for Registration Fee Payment.
9. Post-Market Surveillance Plan: Have a plan for monitoring the device post-market.
10. Review and Finalize Documentation: Ensure all documents are complete and compliant.

By completing this preparatory work, you will be in a strong position to submit a successful application for the registration of your Class A medical device with MDA in Malaysia.

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