In the current scenario of COVID-19, Ultrasound machine is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of Ultrasound machine, meeting the demand right on time would be challenging.
To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent Ultrasound machine manufacturer, you might be willing to market your product across the globe or to be specific in the USA. But do you know how Ultrasound machine is classified in the USA? How United States Food and Drug Administration (US FDA) regulates Ultrasound machine devices?
Have all your questions answered regarding:
- Ultrasound machine Registration/notification in the USA
- US FDA Ultrasound machine Regulations
In addition, some global health authorities have already expedited their Regulatory pathways for Ultrasound machine. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline Ultrasound machine global market entry with the best of regional Regulatory information and structural Regulatory approach.
As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registrations/notifications of Ultrasound machine in the USA.