September 4th, 2017
The Medical Device Branch of the Health Products Regulation Group of Health Sciences Authority (HSA) launched two schemes which came into effect starting August 1st 2017. They are as following:
(1) Pre-Market Consultation (PMC) Scheme and,
(2) Priority Review Scheme.
HSA is aiming to provide support throughout the device's development life cycle through the introduction of the new schemes. Specifically, the PMC Scheme is launched to "support innovation and device development by ensuring devices are in line with regulatory requirements," while the Priority Review Scheme is to "facilitate timely access for devices that address unmet clinical needs."
Medical Device Pre-Market Consultation & Priority Review Scheme