Regulatory approval assessment for medical devices in US, RU, and BR

US based company

Assessment of the OTC regulatory approval for PEMF based pain management device in US, Russia, and Brazil market

Delivered in depth regulatory environment of different classes of therapies in US, Russia, and Brazil which helped client to understand and map the regulatory challenges for the PEMF based pain therapy
SGA’s provided recommendation and insights which helped client to decide a future course of action in terms of OTC approval assessment, clinical data and regulatory filing procedures

Assessment of the OTC regulatory approval process for PEMF based pain management device in the targeted geography through secondary research

Developed an understanding overview in pain management devices such TENS, PEMF ultrasonic or light based therapies
Provided regulatory scenario and medical devices approval process in the geographies of interest
Identified and developed key products, regulatory classification and their approval status
Developed and delivered the understandings on clinical studies for medical devices and their regulatory requirements
Provided key recommendations, insights and expert advice from regulatory experts from US, Russia and Brazil

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