Showing flexibility in the face of the needs presented by the COVID-19 pandemic, health authorities in Singapore are facilitating the approval of medical devices used to decontaminate respirators. In establishing the provisional authorization pathway for the Class C devices, the Health Sciences Authority (HSA) is facilitating access to essential equipment in fighting the virus.
Under the provisional authorization pathway, companies seeking approval for such a decontamination device will need to supply evidence of its safety and effectiveness in reducing pathogens. Then the HSA will fast track its evaluation. If provisional authorization is granted, the importer or distributor of the device would be obligated to submit periodic device performance reports to the HSA.
Earlier, the HSA granted similar provisional authorization for COVID-19 test kits and regulatory flexibility for respiratory devices.