The registration process for a Class A (low-risk) medical device with the Medical Device Authority (MDA) in Malaysia involves several steps to ensure compliance with the Medical Device Act 2012 and the Medical Device Regulations 2012. Here’s a step-by-step guide for Class A device registration:

1. Confirm Device Classification

• Ensure the product is indeed a Class A (low-risk) medical device, which typically includes non-invasive products like bandages, stethoscopes, and non-sterile surgical instruments.

2. Appoint an Authorized Representative (AR)

• If you are a foreign manufacturer, you must appoint a local Authorized Representative (AR) in Malaysia. The AR acts on your behalf for regulatory communication and submission processes with the MDA.
• The AR must be registered with the MDA to submit the device application.

3. Prepare Necessary Documentation

• ISO 13485 Certification: Ensure the manufacturing facility has ISO 13485 certification, which is required for medical device quality management compliance.
• Technical Documentation: Prepare a technical file or documentation dossier, which should include:
  • Device description and intended use
  • Design and manufacturing details
  • Safety and performance information
  • Labeling and instructions for use
• Declaration of Conformity: For Class A devices, a self-declaration of conformity signed by the manufacturer or AR is typically sufficient. This declaration confirms compliance with regulatory requirements.

4. Register on the MeDC@St Portal

• Create an account on Malaysia’s Medical Device Centralized Online Application System (MeDC@St).
• Upload all necessary documents, including the technical file, ISO 13485 certificate, and declaration of conformity, to the portal.

5. Submit the Application and Pay Fees

• Complete the application by filling in all required fields and ensuring all documentation is uploaded.
• Pay the relevant registration fees through MeDC@St. Fees may vary depending on the application type and device specifics.

6. Await MDA Review

• The MDA will review the application. For Class A devices, this review process is usually less rigorous compared to higher-risk devices, given the low-risk classification.
• The MDA primarily checks for proper documentation and compliance with the ISO 13485 standard and other regulatory guidelines.

7. Receive Registration Certificate

• Upon approval, the MDA will issue a registration certificate, authorizing the sale and distribution of the device in Malaysia.
• The certificate is valid for five years, after which it must be renewed.

8. Post-Market Surveillance and Compliance

• Maintain compliance with post-market requirements, including reporting adverse events, if any, and ensuring consistent quality control.
• Keep updated with any changes in MDA regulations to ensure ongoing compliance.

Summary of Requirements:

• ISO 13485 Certification: For quality management.
• Technical Documentation: Detailed product information and compliance records.
• Declaration of Conformity: Self-declaration by the manufacturer or AR.
• Submission on MeDC@St: Online submission and fee payment.

Following these steps carefully will streamline the registration process for Class A medical devices in Malaysia, helping you comply with MDA regulations and achieve market access effectively.

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