In the current scenario of international health crisis, Pulse Oximeters are considered as a few of the critical products to protect oneself and the society overall. Given the importance of pulse oximeters (fingertip) in fighting back COVID-19, there is a growing demand for such products among the health care professionals and the other segments of global population. To live up to the increasing demand, the need of the hour is to quickly develop and market pulse oximeters and build the global supply chains stronger than ever.
However, the key factor en-route is the products’ adherence to regional compliance standards. it’s important to do a prior compliance check to fast track the fingertip pulse oximeter’s global registration. As each country has its own Regulatory prerequisites for pulse oximeter’s classification, notification, licensing, and registration, at times, manufacturer’s compliance preparedness stands significant for quick health authority reviews and approvals. What if manufacturers are unsure of their targeted market’s regional Regulatory standards or procedures for the pulse oximeter registration?
As a proven Regulatory partner for many global companies, and with a vast global presence and robust affiliate network, Freyr shoulders the responsibility of registering pulse oximeters globally in adherence with the regional compliance standards.