Guidance on Preparation of a Product Registration Submission for General Medical Devices

INTRODUCTION

• Objective: This document provides guidance on how to prepare a product registration submission for general medical devices using the ASEAN Common Submission Dossier Template (CSDT).
• Background: The document highlights that product registration applications may follow either the ASEAN CSDT or the International Medical Device Regulators Forum (IMDRF) Non-In Vitro Diagnostic Device Market Authorisation Table of Contents.
• Scope: Applicable to all general medical devices; excludes in-vitro diagnostic medical devices.
• Definitions: Provides essential terms and phrases defined under relevant regulations and guidance.

POINTS TO NOTE WHEN PREPARING A PRODUCT REGISTRATION SUBMISSION

• Dossier Preparation: Must be in English, complete, and all non-applicable sections must be justified.
• Supporting Documents: Must be legible, complete, and current certificates must be included.
• Report Sign-off: All included reports must be signed and dated by an authorized individual.
• Evaluation Route: Detail level varies based on evaluation type (immediate, expedited, abridged, full).
• Submission Method: Required to upload submissions through the Medical Device Information and Communication System (MEDICS).

ELEMENTS OF THE ASEAN CSDT

• Executive Summary: Must include:

  • Commercial marketing history and regulatory approval list.
  • Overview of important safety and performance information.
  • Description of intended use and indications.
  • Any unique features or background related to the device.

• Essential Principles & Evidence of Conformity: Includes:

  • A conformity checklist demonstrating alignment with applicable standards.
  • Declaration of Conformity (DoC).
  • List of relevant standards followed in product design and manufacture.

• Device Description: This section needs:

  • A comprehensive description including technology, functionalities, and features.
  • Information on accessories and their configurations.
  • Software development lifecycle details, if applicable.

• Design Verification & Validation: Should cover:

  • Evidence of physical/mechanical property testing.
  • Electrical safety and electromagnetic compatibility information.
  • Software verification reports and traceability analysis.

• Clinical Evidence: Requires:

  • A clinical evaluation report signed by an expert, summarizing all clinical data.
  • Review of clinical literature and any registries or post-market surveillance data.

• Device Labelling: Must include:

  • Samples of primary and secondary labels.
  • Instructions for Use (IFU) for the device and accessories.

• Risk Analysis: Should provide:

  • A risk management report notifying identified risks, severity, and mitigation strategies.
  • An overall risk management approach for all foreseeable risks including cybersecurity concerns.

• Manufacturer Information: Needs:

  • Names and addresses of all manufacturing and sterilisation sites.
  • Certificates and comparable audits where ISO13485 or MDSAP is not available.
  • A diagram illustrating the manufacturing process flow.