Medical devices – regulatory & GMP

Medical devices  regulatory advice & support

  • Been looming for some time…
    • Canadian SOR-98-282 Medical Device Regulations now underpinned by MDSAP,  CMDCAS is no more!
    • ISO 13485:2016,  now externally audited via MDSAP,  but still OK for Class IIa in Australia (ie no design controls)
    • CE Marking
      • EU Medical Device Directives (Articles and Annexes) to be overtaken by the Medical Device Regulations,
      • MEDDEVs partially subsumed by the MDRs,
      • But still pending Brexit and COVID-19
    • US FDA inc GMP as per 21CFR-820, but MDSAP suits for routine surveillance,
    • Japan Ord 169  included in MDSAP,
    • Australian TGA regs included in MDSAP,
    • Taiwan FDA upping the ante,
    • Korea MFDS seeking separate external audit.
  • Medical devices regulatory surveillance
    • Get a monthly report vs your product codings…

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