REGULATORY UPDATE | HSA update on Guidance Special Access Routes

The Health Sciences Authority of Singapore (HSA) issued a new regulatory update attached to the document ( Guidance on Special Access Route (SAR) Rev 2) relating to the two special access routes GN-26 and GN-27. GN-26 qualified practitioners are licensed 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). This regulatory document has entered into force on April 1, 2022. The Ministry of Health of Singapore will review the clinical justification of Class D medical devices under the categories New technologies and advanced medical devices for clinical use‎ and Unregistered implants.

For class C and D medical devices that are not registered, they must be approved by the Head of the Health Agency or equivalent. As for class D medical devices implemented by the PHI Public Health Institute, for clinical justification it must be verified by the Ministry of Health.

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