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Ventilator Registration/Notification in the USA

In the current scenario of COVID-19, Medical Ventilator is considered as one of the critical products for immediate supply. But with the decline in the global supply chain of Medical Ventilator, 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 Medical Ventilator manufacturer you might be willing to market your product across the globe or to be specific in the USA. But do you know how Ventilators are classified in USA by the United Sates Food and Drug Administration (US FDA)? How the US FDA regulates Ventilators?

Have all your questions answered regarding:

  • Medical Ventilator Registration/Notification in the USA
  • US FDA Medical Ventilator Regulations
  • Medical Ventilator GMP as per US FDA

In addition, some global health authorities have already expedited their Regulatory pathways for Medical ventilator. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline medical ventilator 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 registration/notification of medical ventilator in the USA. 

  • Ventilator For a different country?

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