The requirements for Class A medical device registration with the Medical Device Authority (MDA) in Malaysia focus on ensuring that low-risk devices meet necessary safety and quality standards. Here is a list of the key requirements:

1. ISO 13485 Certification

• The manufacturer must have a valid ISO 13485 certification, which demonstrates compliance with quality management standards specific to medical devices.
• This certification is required to confirm that the device’s manufacturing processes adhere to international quality standards.

2. Technical Documentation

• Prepare a technical file containing all necessary documentation that describes the device’s design, performance, and safety details. The technical file should include:
  • Device Description: Detailed information about the device, including its purpose, components, and intended use.
  • Labeling and Instructions for Use: Labels and any other instructions provided with the device for end users, ensuring clarity on safe usage.
  • Design and Manufacturing Details: Information on the manufacturing processes and controls, along with any relevant design aspects.
  • Safety and Performance Data: Evidence supporting the device’s safety and effectiveness for its intended purpose.

3. Declaration of Conformity

• A Declaration of Conformity (DoC) is required, typically as a self-declaration by the manufacturer for Class A devices.
• This declaration confirms that the device complies with Malaysian regulatory requirements under the Medical Device Act 2012 and applicable international standards.

4. Authorized Representative (AR)

• For foreign manufacturers, a local Authorized Representative (AR) must be appointed to submit the application to the MDA and act as a liaison.
• The AR must be registered with the MDA and is responsible for submitting documents and coordinating with the MDA on behalf of the manufacturer.

5. Registration on MeDC@St (Medical Device Centralized Online Application System)

• All documents and applications must be submitted via MeDC@St, the online portal used by the MDA for device registration.
• The applicant (either the manufacturer or the AR) must create an account on MeDC@St to upload documentation and submit the application.

6. Fee Payment

• Pay the registration fee as per the MDA’s fee structure for Class A devices. The amount may vary depending on whether the device is imported or locally manufactured.

7. Post-Market Surveillance Compliance

• Once approved, ensure ongoing compliance with post-market surveillance requirements, including:
  • Adverse event reporting if any issues arise with the device post-distribution.
  • Regular quality control and documentation updates to reflect any changes to the device or manufacturing processes.

Summary Checklist:

• ISO 13485 Certification
• Technical Documentation (device description, labeling, design, safety data)
• Declaration of Conformity (self-declaration for Class A)
• Authorized Representative (for foreign manufacturers)
• MeDC@St Registration and Submission
• Fee Payment
• Post-Market Surveillance and Compliance

Meeting these requirements is essential to obtaining MDA approval for Class A devices, allowing them to be legally marketed and distributed in Malaysia.

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