Registration in Regulatory Bodies

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Medical device manufacturers must register their products and establishments with regulatory bodies to legally market their devices. 

This includes registration with:

  • FDA (Food and Drug Administration): For the US market, registration with the FDA is essential, along with compliance with FDA regulations.
  • MHRA (Medicines and Healthcare products Regulatory Agency): In the UK, MHRA registration is necessary post-Brexit for marketing medical devices.
  • EUDAMED (European Database on Medical Devices): Under EU regulations, registration with EUDAMED facilitates market surveillance and transparency.
  • ANVISA (Agência Nacional de Vigilância Sanitária): Brazil's regulatory authority requires registration for medical device importation and marketing.
  • SFDA (Saudi Food and Drug Authority): Registration with SFDA is mandatory for medical device importation and marketing in Saudi Arabia.
  • CFDA (China Food and Drug Administration): For the Chinese market, registration with CFDA is necessary, following China's regulatory requirements. Navigating the registration process in different regions requires thorough understanding and compliance with each regulatory body's specific requirements.