REGULATORY UPDATE | HSA Update on Guidance for Special Access Routes

The Health Sciences Authority (HSA) of Singapore has issued a new regulatory update, titled "Guidance on Special Access Route (SAR) Rev 2," concerning two special access routes: GN-26 and GN-27.

GN-26 pertains to qualified practitioners who are licensed to seek approval for the import and supply of unregistered medical devices for use on their patients GN-27 relates to healthcare facilities licensed under the Private Hospitals and Medical Clinics Act (PHMCA). This regulatory document came into effect on April 1, 2022.

The Ministry of Health of Singapore will review the clinical justification for Class D medical devices that fall under the categories of new technologies and advanced medical devices for clinical use, as well as unregistered implants.

For Class C and D medical devices that are not registered, approval must be obtained from the Head of the Health Agency or an equivalent authority. In the case of Class D medical devices implemented by the Public Health Institute (PHI), clinical justification must be verified by the Ministry of Health.

For more information, please visit www.hsa.gov.sg