In the current scenario of COVID-19, ECG (Electrocardiograph) is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of ECG, 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 ECG manufacturer, you might be willing to market your product across the globe or to be specific in the USA. But do you know how ECG is classified in the USA? How United States Food and Drug Administration (US FDA) regulates ECG (Electrocardiograph)?
Have all your questions answered regarding:
- ECG (Electrocardiograph) Registration/notification in the USA
- US FDA ECG (Electrocardiograph) Regulations
In addition, some global health authorities have already expedited their Regulatory pathways for ECG. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline ECG 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 ECG in the USA.