Update to Guidance on Special Access Routes (SAR) Takes Effect 1 April, 2022
Singapore’s Health Sciences Authority published new updates to the guidance document titled ‘Guidance on Special Access Route (SAR) Rev 2’. The announcement is part of HSA’s effort to strengthen regulatory oversight on the importation and local use of unregistered high-risk medical devices requested by qualified practitioners or public healthcare facilities. This guidance document takes effect on April 1, 2022, and pertains to:
- GN-26 For licensed qualified practitioners to seek approval for the import and supply of unregistered medical devices for use on their patients.
- GN-27 For healthcare facilities licensed under the Private Hospitals and
Medical Clinics Act (PHMCA) / Healthcare Services Act (HCSA) to seek approval for the import and supply of unregistered medical devices for use on their patients.
Additional precautions to ensure these devices are used to meet real clinical needs include the endorsement of the SAR application by the Chairman of the Medical Board (CMB) of the Public Healthcare Institution (PHI) or equivalent. In addition, the Ministry of Health (MOH) Singapore will review the clinical justification for Class D medical devices in the categories below:
- New technologies and state-of-the-art medical devices for clinical use
- Unregistered implants
This information shall be furnished by a qualified practitioner/Head of Department (HOD) of a Public Healthcare Institution (PHI) and could be submitted via the Clinical Justification Review Form in the application process. The MOH will communicate directly with the applicant for any clarifications.
It is important to note that:
- Unregistered medical devices should obtain at least one reference regulatory agency approval from AU TGA, HC, Japan MHLW, US FDA, or EU NB.
- The importer should possess a certified QMS (e.g. to the requirement of Good Distribution Practice for Medical Devices GDPMDS).
Turnaround time for approval of specific categories of unregistered Class D devices is expected to increase with the additional review on clinical justification by MOH. More details can be found at: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/guidance-on-special-access-routes-(sar)-(18mar-pub).pdf