Oct 30, 2019
The Singapore Health Sciences Authority (HSA) has issued new guidance on Special Authorization Routes (SARs) for medical devices not yet registered in the country.
SARs allow qualified healthcare providers in Singapore to utilize unregistered devices in emergency cases, 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 eligible for HSA’s SAR program to obtain Singapore market entry.
The Health Sciences Authority (HSA), Singapore’s medical device market regulator, is introducing revisions to its change notification system for medical devices effective December 1, 2015.
The Health Sciences Authority, Singapore’s medical device market regulator, has published a new risk classification tool for medical devices and IVDs.