For Class A medical device registration with the Medical Device Authority (MDA) in Malaysia, certain documentation is required to ensure compliance with Malaysia's Medical Device Act 2012 and Medical Device Regulations 2012. Below is a comprehensive list of the required documents and guidance on how to prepare them.

Required Documents for Class A Medical Device MDA Registration

1. ISO 13485 Certification

   • What it is: ISO 13485 is an international standard for quality management systems specific to medical devices.
   • How to Prepare: Obtain a valid ISO 13485 certification from a recognized body. Ensure that the manufacturing facility complies with the requirements of this standard. If your facility is not already ISO 13485 certified, it will need to undergo a certification audit, which can take several months.
   • Document Needed: A copy of the ISO 13485 certification issued by the certifying body.

2. Technical Documentation (Technical File)

   • What it is: This is a comprehensive file that provides detailed information about the device, its design, intended use, performance, and safety.
   • How to Prepare:
     • Device Description: Provide a detailed description of the device, including its intended use, components, materials, and any risks associated with the device.
     • Design and Manufacturing Details: Include information on how the device is designed and manufactured, any standards it adheres to, and the procedures for ensuring quality control during production.
     • Safety and Performance Data: Provide evidence that the device meets necessary safety and performance standards, which could include laboratory testing results or other performance data.
     • Labeling and Instructions for Use: Include a copy of the labeling and user instructions in compliance with the Malaysian regulations. Labels should have necessary information such as the manufacturer’s name and address, intended use, and safety warnings. The instructions for use must be clear and detailed for the intended user.
     • Biocompatibility or Performance Testing (if applicable): If applicable, include results from biocompatibility testing or other relevant performance testing to prove that the device is safe for its intended use.
   • Documents Needed:
     • Device Description
     • Design and Manufacturing Process Information
     • Safety/Performance Data (test reports, certifications)
     • Labeling
     • Instructions for Use

3. Declaration of Conformity

   • What it is: The manufacturer or Authorized Representative (AR) must declare that the device complies with Malaysian regulations.
   • How to Prepare: The Declaration of Conformity (DoC) should state that the device conforms to the applicable Malaysian regulatory standards. For Class A devices, this is usually a self-declaration by the manufacturer, confirming that the device meets the essential safety and performance requirements.
   • Document Needed: A signed Declaration of Conformity from the manufacturer or the AR. This document should also include the device’s regulatory status, classification, and applicable standards.

4. Authorized Representative Appointment Letter (for foreign manufacturers)

   • What it is: Foreign manufacturers are required to appoint a local Authorized Representative (AR) who will submit the registration on their behalf and act as a point of contact with the MDA.
   • How to Prepare: The appointment letter must be signed by both the manufacturer and the appointed AR, confirming that the AR has the authority to represent the manufacturer in Malaysia.
   • Document Needed: Signed appointment letter from the foreign manufacturer, including the AR’s details (name, address, registration number).

5. MeDC@St Online Registration Form

   • What it is: An online registration form must be filled out via the MeDC@St portal (Medical Device Centralized Online Application System) for submitting the application.
   • How to Prepare: Register for an account on the MeDC@St portal https://medcast.mda.gov.my. Fill out the form by providing accurate details of the device, its classification, intended use, and manufacturer details.
   • Document Needed: Completed online application form available on the MeDC@St portal.

6. Product Testing or Compliance Documentation (if applicable)

   • What it is: If your device has undergone any form of regulatory testing or complies with specific standards (such as EMC, electrical safety, etc.), include these reports as supporting documentation.
   • How to Prepare: Gather reports or certifications from testing laboratories or regulatory bodies that prove the device complies with the required standards.
   • Document Needed: Test reports or certificates confirming compliance with relevant standards.

How to Prepare Application Documents

1. Ensure All Documents Are Complete:

   • Double-check that all required documents are included and complete before submission. Incomplete documentation will result in delays in the approval process.

2. Ensure Compliance with Malaysian Regulations:

   • The labeling, instructions, and all documentation must comply with the Malaysian Medical Device Regulations. For example, the instructions for use should be in both English and Malay, where applicable.
   • The Declaration of Conformity should reflect compliance with the Medical Device Act 2012 and any applicable regulations.

3. Translate Documents if Necessary:

   • If your documents are in a language other than English or Malay, they will need to be translated before submission. Ensure translations are accurate and certified if required.

4. Use MeDC@St Portal Effectively:

   • Familiarize yourself with the MeDC@St portal and ensure you follow the step-by-step instructions for uploading your documents.
   • Be sure to provide accurate and consistent information across all forms, declarations, and technical documents.

5. Ensure ISO 13485 Compliance:

   • If your manufacturing facility is not ISO 13485 certified, you will need to obtain this certification before applying. The certification process includes an audit of your facility's quality management system to ensure compliance with medical device standards.

Additional Tips and Precautions

1. Authorized Representative:

   • If you are a foreign manufacturer, ensure that your AR is familiar with the MDA’s requirements and can guide you through the registration process. An AR is a key point of contact with the MDA.

2. Testing Documentation:

   • For certain Class A devices, you may be required to provide biocompatibility or electrical safety testing data. Even though Class A devices are low-risk, some devices (e.g., diagnostic tools, non-invasive surgical instruments) may require additional documentation to prove their safety.

3. Regulatory Updates:

   • Stay updated with any changes to regulations or fees by regularly checking the MDA website or the MeDC@St portal. Regulatory changes can affect the required documentation or processing times.

By preparing all documents carefully and ensuring compliance with MDA regulations, you can facilitate a smooth and efficient registration process for your Class A medical device in Malaysia.

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