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GENERAL MEDICAL DEVICES FOR APPROVAL IN THE ASEAN REGION

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When submitting general medical devices for approval in the ASEAN region, it is essential to follow the guidelines and standards set by the ASEAN Common Submission Dossier Template (CSDT) and the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format. MEDICS (Medical Device Information and Communication System) is a platform used by some ASEAN countries for the submission and management of medical device regulatory dossiers. This blog will guide you through the eSubmission process for general medical devices using ASEAN CSDT and IMDRF ToC-based submissions in MEDICS.

Overview of ASEAN CSDT and IMDRF ToC

ASEAN CSDT

The ASEAN CSDT is a standard format for submitting regulatory information about medical devices in the ASEAN region. It aims to harmonize the submission requirements for medical devices across different ASEAN member states. The CSDT format includes the following sections:

  1. Executive Summary: Provides an overview of the device and its intended use, including a brief description of the manufacturer and the device.
  2. Relevant Essential Principles and Method of Conformity: Lists essential principles of safety and performance and describes how the device complies with them.
  3. Device Description: Detailed information about the device, including design, components, accessories, and labeling.
  4. Device Verification and Validation Documents: Evidence of verification and validation activities for the device, including performance data, safety data, and clinical evaluation.
  5. Device Risk Analysis: A risk management report demonstrating the manufacturer’s approach to identifying, evaluating, and controlling risks.
  6. Manufacturer Information: Details about the manufacturer, including quality management systems and post-market surveillance plans.

IMDRF ToC

The IMDRF ToC format provides a standardized structure for medical device submission dossiers. It is recognized globally and includes the following sections:

  1. Section 1 – Device Description: Description of the device, its intended use, and details about its design and manufacturing.
  2. Section 2 – Device Specifications: Includes information about the physical and chemical properties of the device, including materials, specifications, and testing.
  3. Section 3 – Labeling and Packaging: Details about the labeling, packaging, and instructions for use.
  4. Section 4 – Pre-Clinical Studies: Evidence of pre-clinical studies conducted for the device.
  5. Section 5 – Clinical Evidence: Clinical evaluation and investigation reports demonstrating the safety and effectiveness of the device.
  6. Section 6 – Manufacturing Information: Information about the manufacturing processes and facilities.
  7. Section 7 – Post-Market Surveillance: Details about the manufacturer’s post-market surveillance plan.

MEDICS Submission Process

MEDICS (Medical Device Information and Communication System) is a platform used in some ASEAN countries for the submission and management of medical device regulatory dossiers. Here’s how to proceed with a MEDICS submission for general medical devices using the ASEAN CSDT and IMDRF ToC formats:

  1. Prepare the Dossier: Prepare your submission dossier according to either the ASEAN CSDT or IMDRF ToC format. Make sure to include all required sections and provide accurate and complete information.
  2. Convert the Dossier: Convert your dossier into a digital format, ensuring it meets the MEDICS platform’s technical requirements.
  3. Create an Account: Register an account on the MEDICS platform if you haven’t already done so.
  4. Log In and Submit: Log in to your MEDICS account and begin the submission process. Follow the platform’s instructions to upload your dossier.
  5. Track the Submission: After submitting your dossier, you can track its progress through the MEDICS platform. You may receive requests for additional information or clarifications from regulatory authorities.
  6. Respond Promptly: If requested, respond to any queries or requests for additional information promptly to avoid delays in the review process.
  7. Maintain Records: Keep records of your submission and any communication with regulatory authorities for future reference.

By following these guidelines and using the MEDICS platform, you can streamline the submission process for general medical devices in the ASEAN region. This approach ensures that your submissions comply with regional and international standards, increasing your chances of successful approval and market entry.

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