To facilitate the preparation and the review process of the medical device registrations dossiers using the ASEAN CSDT (Association of Southeast Asian Nations Common Submission Dossier Template), Singapore’s Health Sciences Authority (HSA) has been working on improving the contents of their online materials.

HSA updates guidance documents for medical device and IVD registration dossiers

As part of their ongoing efforts to support their stakeholders, HSA’s intention was to provide a simple and reader friendly layout, improve the accessibility to information (through guidance documents and templates) and provide greater clarity through salient and succinct submission documents.

A public stakeholders’ consultation was held until December 24, 2018, and produced the following documents:

  • Two revamped guidance documents, on the Preparation of a Product Registration Submission for General Medical Devices (GN-17) and In-Vitro Diagnostic Medical Devices (GN-18) using the ASEAN CSDT;
  • Two product registration submission guides: E-submission Guidance for General Medical Devices and In-Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC (International Medical Device Regulators Forum Table of Contents) based submissions in MEDICS (Medical Device Information and Communication System);
  • Two Technical Reference documents: Contents of a Product Registration Submission for General MedicalDevices (TR-01) and for In Vitro Diagnostic Medical (TR-02) using the ASEAN CSDT to reflect the updated content of the GN‐17 and GN‐18 guidance documents.