The Food and Drug Administration is responsible for ensuring that food, drugs, and certain other products and processes are safe for consumers from USA.
The Brazilian Health Regulatory Agency is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System as the coordinator of the Brazilian Health Regulatory System.
The Colombia National Food and Drug Surveillance Institute is in charge of inspecting and supervising the marketing and manufacturing of health products, and providing medical approval for the import and export of products.
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.
Medical Device Software.
Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability.
Application of risk management to medical devices.