30 Day Trial
Regulatory Guidance
 

We welcome submissions for consideration. Please send your agency information to Julie Vetalice at ORTHOWORLD.

  Americas
  Brazil   National Health Surveillance Agency (ANVISA)
  Brazil   National Institute of Metrology, Quality and Technology (INMETRO)
  Canada   Health Canada
  Colombia   Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
  Costa Rica   Ministry of Health
  Mexico   COFEPRIS | Ministry of Health
  Peru   Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)
  United States   Clinical Trials (Federally/privately supported clinical research in human volunteers)
  United States   U.S. Food and Drug Administration (division of the Center for Devices and Radiological Health)
  United States   Search: FDA/CDRH 510(k) (Premarket Notification) Database
  United States   Search: FDA/CDRH Advisory Committe/Panel Meetings Database
  United States   Search: FDA/CDRH MAUDE (Manufacturer and User Facility Device Experience) Database
  United States   Search: FDA/CDRH   MDR (Medical Device Reporting) Database
  United States   Search: FDA/CDRH Medical Device Recall Database
  United States   Search: FDA/CDRH PMA (Premarket Approval) Database
  EMEA
  Egypt   Central Administration of Pharmaceutical Affairs
  Europe   European Commission Medical Device Guidance
  Europe   European Medicines Agency
  Europe   Nando (New Approach Notified and Designated Organisations) Information System
  Europe   Regulatory Affairs Professionals Society: Essential List of European Pharmaceutical and Device Regulatory Authorities
  Israel   Ministry of Health
  Russia   Federal Service for Surveillance in Healthcare (Roszdravnadzor)
  Saudi Arabia   Food and Drug Authority
  South Africa   Department of Health
  Turkey   Ministry of Health
  United Kingdom   Medicines and Healthcare Products Regulatory Agency
  Asia Pacific
  Australia   Therapeutic Goods Administration
  China   China Food and Drug Administration
  Hong Kong   Department of Health | Medical Device Control Office
  India   Central Drug Standards Control Organisation
  Japan   Pharmaceuticals and Medical Devices Agency
  Malaysia   Medical Device Authority | Ministry of Health
  New Zealand   Medicines and Medical Devices Safety Authority
  Singapore   Health Sciences Authority
  South Korea   Ministry of Food and Drug Safety
  Taiwan   Food and Drug Administration