Singapore MOH has updated the “MOH Clinical Justifications Form for Class D SAR Application” for the GN-26 and GN-27 SAR for unregistered medical devices:
a. GN-26: For licensed Qualified Practitioner (QP) to seek approval for the import and supply of unregistered medical devices for use on his patient.
b. GN-27: For laboratories and medical 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.
Public Healthcare Institutions (PHIs) seeking approval for the import and supply of unregistered Class D medical devices that fall under the categories in Table 1 will need to submit the clinical justifications form for MOH’s approval. The application turnaround time (TAT) will be extended by another 14 working days (from current TAT 14 working days) for MOH’s review. The form is to be completed by the Head of Department or equivalent of the PHI, and endorsed by the Chairman Medical Board (CMB) or equivalent of the PHI.
Table 1: Class D medical devices that require approval from MOH for the use of the device.
• New technologies and state-of-the-art medical devices for clinical use on patients, including novel indications for existing medical devices or technologies. They can expose healthcare professionals and patients to significant risks as these unregistered medical devices have not been reviewed by HSA for their safety and effectiveness
• Unregistered implants (e.g. pacemakers, breast implants) as implants can fail post surgery, and give rise to long term complications, e.g. repeat or revision surgeries, or other clinical interventions that are likely to expose patients to further risks/complications
GN-35 Guidance on Special Access Routes has also been updated to reflect the extended TAT for applications requiring MOH review. The updated documents are published at https://www.hsa.gov.sg/medical-devices/guidance-documents