approvals / certifications

  relevant for implants

A ANVISA Brazil Agência Nacional de Vigilância Sanitária
  ASTM World ASTM International(formerly American Society for Testing and Materials)
C CDSCO India Central Drugs Standard Control Organisation, Directorate General Of Health Services Ministry of Health &Family Welfare, Government of India
  CE marking Europe Conformity with European health, safety, and environmental protection standards
  CENELEC Europe European Committee for Standardization
  CFDA China China Food and Drug Association State Administration for Market Regulation
  clean implant World Clean implant foundation
D DIN Germany Deutsche Industrie Norm
  DOH Taiwan renamed in Taiwan´s Ministry of Health
E EN 45502-2-1 Europe Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
F FDA Mexico See Registrar Corp
  FDA Philippines Food and Drug Administration Philippines
  FDA U. S.A. Food and Drug Administration (FDA or USFDA)
H HC Canada Health Canada
  HSA Singapore Health Science Authority
I ICS 11.040.01 World Medical Equipment in General
  ICS 11.100.20 World Biological Evaluation of medical Devices
  IEC 60601-1:2005 World Requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment
  IEC 62304 World International Electrotechnical Commission (IEC), medical device software
  ISO World International Organization for Standardization
  ISO 13485 World Quality Management Systems for medical devices in the production process
  ISO 14971 World Medical devices — Application of risk management to medical devices (voluntary standard)
  ISO/TC 150 World Standardization in the field of implants for surgery
M MHI Indonesia Ministry of Health of Indonesia
  MHLWJ Japan Ministry of Health, Labor and Welfare of Japan
  MHWK Kazakhstan Ministry of Health and Welfare of Kasakhstan
  MHV Vietnam Ministry of Health of Vietnam
  MOH Russia Ministry of Health of the Russian Federation
N NAMed Germany DIN-Normenausschuss Medizin
P Patent World, regional industrial property right for an invention that is valid for a certain period of time
  Registrar Corp World Helps businesses comply with U.S. Food and Drug Administration (FDA)
T TGA Australia Therapeutic Goods Administration, Australian Government Department of Health
U USFDA U.S.A. USA Food and Drug Administration