Regulatory Guidance

We welcome submissions for consideration. Please send your orthopaedic-focused publication 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 De Novo Clearance 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 Pharmaceutical and Device Regulatory Authorities in Asia
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 National Medical Products 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