Before applying for D-class medical device registration in Malaysia, manufacturers and distributors must conduct thorough preparatory work to ensure compliance with Malaysian regulations and streamline the application process. D-class medical devices are considered high-risk, and preparation requires gathering comprehensive documentation and ensuring that all necessary technical and regulatory standards are met. Below are the critical preparatory steps:

1. Conduct a Classification of the Medical Device

• Confirm Device Classification: Ensure that the medical device is correctly classified as a D-class (high-risk) medical device based on its intended use, risk profile, and how it interacts with the body. If uncertain, refer to the Malaysian Medical Device Authority (MDA) Classification Guidelines or seek assistance from a regulatory consultant to avoid misclassification.

2. Establish a Quality Management System (QMS)

• ISO 13485 Certification: Implement a Quality Management System (QMS) in compliance with ISO 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes). This is mandatory for medical device manufacturers and demonstrates adherence to quality standards throughout the design, production, and post-market phases.
• Document Control: Ensure all documents related to the QMS, such as Standard Operating Procedures (SOPs), quality manuals, and records, are well-maintained and up to date.

3. Prepare the Technical Documentation

• Essential Documents: Compile the following technical documentation to demonstrate the safety, quality, and performance of the device:
  • Device Description and Specifications: A detailed description of the device, including its design, components, and materials.
  • Risk Management Report: A report following ISO 14971 detailing how risks have been identified, assessed, and mitigated throughout the device lifecycle.
  • Clinical Evaluation Report: Evidence demonstrating the safety and clinical performance of the device, including clinical data or trial reports (if applicable). Compliance with ISO 14155 is essential for clinical investigations.
  • Biocompatibility and Testing Data: Provide biocompatibility test reports in line with ISO 10993, especially for devices that come into contact with human tissues.
  • Electrical Safety: For electrically powered devices, provide reports on compliance with IEC 60601 (safety of electrical medical devices).
  • Software Verification and Validation (if applicable): For devices containing software, submit verification and validation documents in compliance with IEC 62304.
  • Packaging and Sterility Data: If the device is sterile, include packaging validation reports in compliance with ISO 11607.

4. Appoint an Authorized Representative (AR)

• Local Authorized Representative: Foreign manufacturers must appoint a Malaysian-based Authorized Representative (AR) to liaise with the MDA. The AR is responsible for submitting the application, communicating with the MDA, and ensuring post-market compliance.
• Authorized Representative License: Ensure the AR holds a valid Establishment License issued by the MDA, which allows them to register medical devices and act on behalf of the manufacturer.

5. Engage a Conformity Assessment Body (CAB)

• Select a CAB: Manufacturers must engage a Conformity Assessment Body (CAB) licensed by the MDA. The CAB will evaluate the device’s technical documentation and confirm its compliance with regulatory requirements.
• Prepare for CAB Audits: Be ready for inspections or audits from the CAB. The CAB will assess the quality management system, technical documentation, and risk management procedures.

6. Conduct a Pre-Submission Gap Analysis

• Self-Assessment: Perform a gap analysis to identify any deficiencies in the technical documentation, testing, or compliance procedures. This will help ensure that all aspects of the registration application are in order.
• Third-Party Review: Consider hiring a regulatory consultant to conduct a third-party review of the submission package, ensuring all required elements are included and compliant.

7. Prepare Labeling and Instructions for Use (IFU)

• Compliant Labeling: Ensure that the device labeling meets the requirements outlined in the Medical Device Regulations 2012 and is consistent with ISO 15223-1 (symbols for labeling).
  • Labeling must include the device name, intended use, manufacturer’s details, batch or serial number, expiry date, sterilization method (if applicable), and any necessary warnings.
• Instructions for Use (IFU): The IFU must provide clear and accurate information on how to safely and effectively use the device, including detailed instructions for healthcare providers or end-users.

8. Obtain Clinical Data (if necessary)

• Clinical Trials: If the D-class device requires clinical evaluation, ensure that clinical trials are conducted following ISO 14155 guidelines. Clinical data must support the safety and efficacy of the device, especially for new or innovative technologies.
• Clinical Data Summary: Prepare a clinical data summary report as part of the submission package. This may include published clinical studies, results from clinical investigations, or post-market data from other regions where the device is already marketed.

9. Ensure Compliance with National and International Standards

• International Standards: The device should comply with all relevant international standards such as ISO 10993, ISO 13485, IEC 60601, IEC 62366, ISO 14971, and ISO 14155. Each standard pertains to a different aspect of the medical device, including biocompatibility, risk management, quality management, electrical safety, software, and usability.
• Malaysian Standards: Ensure the device also complies with the Malaysian Medical Device Act 2012 (Act 737) and its regulations. The device must meet local regulatory requirements for medical device safety, efficacy, and performance.

10. Set Up a Post-Market Surveillance (PMS) System

• Post-Market Surveillance Plan: Prepare a robust Post-Market Surveillance (PMS) plan that includes procedures for monitoring the performance of the device once it is placed on the market. This plan should cover adverse event reporting, corrective actions, and ongoing risk assessments.
• Vigilance System: Implement a vigilance system for reporting serious incidents and adverse events to the MDA as required by the regulations.

11. Compile Registration Fees and Budgeting

• Registration Fees: Ensure that you have accounted for the necessary registration fees, which include the application fee, Conformity Assessment Body (CAB) fees, and other associated costs. The costs for registering a D-class device can vary depending on the complexity of the device and the CAB involved.

12. Register with MeDC@St Online System

• Online Registration Portal: Set up an account with MeDC@St, the MDA’s online medical device registration system. All applications for medical device registration must be submitted through this platform.

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