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Regulatory Compliance

The adherence of medical devices to applicable laws, regulations, and standards in each market where they are sold. In tender response, regulatory compliance means demonstrating valid approvals, current certifications, and documented evidence for each jurisdiction.

Regulatory compliance in medical device procurement means having the correct approvals, certifications, and documentation for each market where you tender. Different countries have different regulatory requirements — a device cleared by the FDA may not automatically be accepted in the EU, Japan, or Australia.

Major regulatory frameworks

  • USA: FDA 510(k), PMA, De Novo
  • EU: EU MDR 2017/745, CE Marking
  • UK: UKCA Marking, MHRA
  • Japan: PMDA Shonin approval
  • Australia: TGA ARTG registration
  • China: NMPA registration
  • Canada: Health Canada MDEL

Related terms

510(k) ClearanceEU MDR (Medical Device Regulation)CE Marking
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