Healthcare, Medical Devices, Regulatory Affairs

Singapore Health Sciences Authority: new guidance on special authorization routes for unregistered medical devices

The Singapore Health Sciences Authority (HSA) has issued new guidance on Special Authorization Routes (SARs) for the unregistered medical devices in the country.

These SARs allow qualified healthcare providers in Singapore to utilize unregistered devices in case of emergencies, or when more conventional therapies have proven unsuccessful.The new guidance covers application processes, requirements and post-market obligations that must be met in order to import an unregistered device into Singapore via SAR.

Devices that meet “special clinical needs,” intended for import/export, as well as those with non-clinical intended uses or purposes may be fall under HSA’s SAR program to obtain Singapore market entry.

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