HSA Regulatory Update: Feedback sought on Low-Volume-Low-Cost medical devices

The Health Sciences Authority (HSA) has announced further enhancements to the regulatory framework for medical devices to facilitate easier and expedited access for lower risk (Class A and B) medical devices as well as a reduction of registration fees. HSA has also received feedback from healthcare professionals that the medical device framework had impeded the importation and supply of low cost medical devices with low volume demand. To facilitate our review of this issue holistically and ensure that the medical needs of our patients are met, HSA is seeking the assistance of healthcare professionals to provide us with the list of low-volume-low-cost devices which they have experienced difficulties in getting supplies.