The process of registering a Class A medical device with the Medical Device Authority (MDA) in Malaysia is relatively straightforward compared to higher-risk devices, but the exact timeline can vary depending on the completeness of the application and any additional requirements or clarifications needed. Here is an overview of the timeframe and the review process:

Timeframe for Class A Medical Device Registration

The registration process for Class A medical devices with MDA typically takes about 1 to 3 months from the submission of the application. This is because Class A devices are considered low-risk and are subject to a simplified review process compared to higher-class devices (Class B, C, or D).

However, the total duration depends on several factors, including:

• Completeness of the application: If all necessary documents are submitted and the device is well-documented, the process will be faster.
• Response time to queries: If MDA requests additional information or clarification, it may extend the processing time. Manufacturers must respond promptly to any requests to avoid delays.
• Workload of MDA: The time may also vary depending on the volume of applications being processed by MDA at the time.

Review Process for Class A Medical Device Registration

The review process for Class A medical devices is generally quicker, but it still follows a set procedure to ensure that the device meets the necessary regulatory standards. Here are the key steps in the review process:

1. Initial Submission:

   • The manufacturer (or their Local Authorized Representative (LAR)) submits the application through the MeDC@St portal along with all required documents, such as:
     • Product description and intended use
     • Risk management documentation
     • Manufacturer’s details and ISO 13485 certification
     • Conformity assessment (e.g., CE marking if applicable)
     • Instructions for Use (IFU) and labeling information

2. Document Check:

   • MDA initially performs a document completeness check. This involves verifying whether the required documents have been submitted and whether they are in the proper format. If any documents are missing or incomplete, MDA may request the manufacturer to provide additional information.
   • Common document checks include:
     • Verifying compliance with ISO 13485
     • Confirming that the device is appropriately classified as Class A
     • Checking that the labeling and instructions for use are in compliance with Malaysian regulations

3. Technical Review:

   • Once the application passes the initial completeness check, MDA will proceed with the technical review of the device’s documentation. This review involves:
     • Risk Management: MDA checks if the device complies with risk management standards (such as ISO 14971), ensuring that the device’s safety and performance risks have been adequately addressed.
     • Conformity to Standards: The device’s compliance with international standards, such as ISO 13485, ISO 10993 (for biocompatibility), and others, is verified. If the device has a CE mark, MDA will ensure it complies with relevant EU standards.
     • Safety and Performance Evaluation: The review also includes an evaluation of the device's intended use, materials, and any other relevant technical specifications.

4. Approval or Query:

   • If MDA finds that the device meets all the necessary regulatory requirements, it will approve the registration and issue a Certificate of Registration.
   • If there are any issues with the application (e.g., incomplete documentation or non-compliance with standards), MDA may issue a query to the manufacturer, asking for clarification or additional information. The manufacturer will need to respond to these queries promptly to avoid delays.

5. Final Decision:

   • Once all queries are addressed, and the review process is complete, MDA will issue the Certificate of Registration for the Class A medical device.
   • This certificate confirms that the device has been approved for sale and distribution in Malaysia, and the device is now included in the MDA's registry of medical devices.

Key Factors Affecting the Review Timeline:

• Completeness of Documentation: The more complete and accurate the submission, the faster the review process will be.
• MDA’s Workload: During peak periods, such as when there is a high volume of submissions, processing times may be longer.
• Response Time: Delays in responding to queries from MDA can extend the registration time.
• Compliance Issues: If the device has any issues related to safety, labeling, or documentation that do not meet MDA’s requirements, this can delay the review process.

In Summary:

• Typical Timeline: 1 to 3 months for Class A medical devices.
• Review Process: The review includes an initial document check, technical review (risk management, safety, and conformity), and issuing approval or requesting clarification. The process is generally faster for low-risk devices but may be delayed if additional information is required.

By ensuring that all required documentation is complete and compliant with MDA's guidelines, the process can be completed smoothly within the expected timeframe.