For the registration of a Class A medical device in Malaysia, the process involves several key steps, the submission of specific materials, and consideration of important factors to ensure compliance with regulations set by the Medical Device Authority (MDA). Here's a detailed guide to the process, required materials, and key considerations:

1. Process for Class A Medical Device Registration

Step 1: Obtain Establishment License

Before you can register a medical device, the manufacturer or Local Authorized Representative (LAR) must have an Establishment License issued by the MDA.

• Apply through the MeDC@St system.
• Submit necessary documents (company registration, ISO 13485 certification, etc.).
• Pay the establishment license fee.

Timeline: Typically 4 to 6 weeks.

Step 2: Classify the Medical Device

Ensure that the device is correctly classified as Class A according to MDA guidelines. Class A devices are low-risk and non-invasive.

• Consult MDA’s classification rules and guidelines.

Step 3: Prepare Technical Documentation

Compile all necessary documentation to demonstrate that the device is safe and effective.

• Device Description: Details on device design, intended use, and function.
• Design and Manufacturing Information: Explanation of manufacturing processes and controls.
• Risk Management Report: Document identifying risks and mitigation measures (e.g., ISO 14971).
• Labeling and Packaging Information: Including product labels, instructions for use (IFU), and packaging.
• Sterilization Details (if applicable): Information on sterilization methods.
• Clinical Evaluation: Not always required for Class A but include if applicable.
• Declaration of Conformity (DoC): A document declaring compliance with relevant standards.

Step 4: Submit the Application via MeDC@St

Use the MeDC@St online system to submit the registration application.

• Log in to MeDC@St or create an account if not already done.
• Complete the registration form for Class A devices.
• Upload the required documentation.
• Pay the registration fee online.

Timeline: Typically 2 to 3 months, depending on the completeness of the submission and MDA’s review workload.

Step 5: Review and Approval by MDA

The MDA will review the application to ensure compliance with regulatory requirements.

• MDA Review: The MDA may request additional information or clarification.
• Approval: Once approved, you will receive a Certificate of Registration.

Timeline: 3 to 6 months in total from submission to approval, depending on factors such as completeness and MDA's review time.

Step 6: Post-Market Surveillance

After registration, comply with post-market surveillance requirements.

• Monitor device performance and report adverse events.
• Maintain records of any issues or corrective actions taken.

2. Required Materials

• Establishment License: Proof of establishment licensing.
• Technical Documentation: Device description, risk management, design and manufacturing details, labeling, etc.
• Declaration of Conformity (DoC): Statement of compliance with applicable standards.
• Instructions for Use (IFU): Clear and detailed instructions for the end-users.
• Labeling Information: Labels and packaging details.
• Sterilization Process Information (if applicable).
• Clinical Evaluation Data (if applicable).

3. Key Considerations

• Compliance with Standards: Ensure the device meets Malaysian regulatory requirements and relevant international standards.
• Quality Management System: Although not mandatory for Class A, having an ISO 13485-certified QMS is beneficial and may streamline the registration process.
• Accuracy and Completeness: Ensure all documents are accurate, complete, and submitted correctly to avoid delays or rejections.
• Fee Structure: Be aware of both the establishment license and registration fees. Check the latest fee structure on the MDA website.
• Consultation: Consider engaging a regulatory consultant to assist with the preparation and submission of documents, especially if you are unfamiliar with the process.
• Post-Market Requirements: Have a plan in place for post-market surveillance and reporting to remain compliant with MDA requirements after registration.

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