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Anti-Microbial Reusable Face Mask

Surgical Masks and N95 Respirators Registration/Notification in the USA

In the current scenario of COVID-19, Surgical/Face Masks and N95 Respirators are considered as few of the critical products for immediate supply. But with the decline in the global supply chains of N95 Respirators/Surgical Masks, 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 Surgical/Face Masks and N95 Respirators manufacturer you might be willing to market your product across the globe or to be specific in the USA. But do you know how Surgical/Face Masks and N95 Respirators are classified in the USA? How the United Sates Food and Drug Administration (US FDA) regulates Surgical/Face Masks and N95 Respirators?

  • Have all your questions answered regarding:
  • N95 Respirators/Surgical Masks License, Notification, Registration in the USA
  • US FDA Surgical Masks and N95 Respirators Regulations
  • USA Surgical/Face Masks and N95 Respirators classification

In addition, some global health authorities have already expedited their Regulatory pathways for N95 Respirators. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline Surgical Masks and N95 Respirator’s 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 Surgical/Face Masks and N95 Respirators in the USA. 

  • Mask (Surgical, Particulate, Respirator, Medical, Patient, Disposable, Reusable, KN95) For a different country?

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