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.<\/p>\n\n\n\n
GN-26<\/strong> 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<\/strong> relates to healthcare facilities licensed under the Private Hospitals and Medical Clinics Act (PHMCA). This regulatory document came into effect on April 1, 2022.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n For more information, please visit\u00a0www.hsa.gov.sg<\/a><\/p>\n\n\n\n