Regulatory approval assessment for medical devices in US, Russia, And Brazil


US based company

Business situation

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

Benefits and outcomes of our engagement

  • 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

SGA approach

  • 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