Preparation of Medical Device Registration Dossier

Overview of Medical Device Registration Dossier

• The document involves updates to guidance documents related to medical devices by the Health Sciences Authority (HSA).

Guidance Documents (GN-17 & GN-18)

• Purpose: Provide technical references and ensure clarity in product registration submission.
• Enhancements: Address issues such as technical complexity, clarity, and industry feedback.

Key Updates to GN-17 & GN-18

• Simplification: Revamped structure to make documents reader-friendly and accessible.
• Layout Changes: A focus on bite-sized information and interactive elements to improve clarity.

Updated Requirements in GN-17 & GN-18

• Standard Input Requests: Queries based on industry feedback.
• Instructions for Use (IFU): Formats for IFUs provided, noting the reference to GN-23 for labeling requirements.
• Safety & Performance Data: Required data for marketing and providing comprehensive evaluations.

Specific Areas of Focus

• Commercial Marketing History: Documentation regarding countries of product distribution and registration details.
• Stability Studies: Submission of both real-time and accelerated stability data, with justifications if certain data is unavailable.
• Cybersecurity: Evidence required for connected medical devices, detailing vulnerabilities, risks, and control measures.
• Preclinical Evidence & Materials: Necessity for safety data on materials used in devices, and preclinical studies for non-IVD accessories.

Technical Reference Documents

• Conversion of existing GN-17 and GN-18 into technical references for better understanding:
  • TR-01: General Medical Devices submissions.
  • TR-02: In Vitro Diagnostic Devices submissions.

Submitting Registration Dossiers

• Dossier submissions must be made online via the Medical Device Information and Communication System (MEDICS).
• All documents should be categorized under the relevant sections in the MEDICS application form.

Challenges in Submission

• High volume of applications from US and EU manufacturers, often formatted according to IMDRF Table of Contents (ToC).
• Ongoing updates to comply with both ASEAN CSDT and IMDRF documentation requirements.

Structure of Submission

• Sections to include:
  • Executive Summary
  • Device Description
  • Clinical and Non-Clinical Evidence
• Ensure correct mapping of the contents to respective MEDICS modules.

Conclusion and Future Actions

• Continuous improvement in content and information accessibility in online materials for stakeholders.
• Future consultations planned for the refined technical reference documents and product registration guides.