Medical devices – regulatory & GMP

Medical devices  regulatory advice & support

  • Coming at you,  recently implemented,
    • Medical Devices Single Audit Programme (MDSAP),
      • Taken over from Canadian CMDCAS end 2018
    • European Medical Devices Regulations (MDRs effective 2020 – CE Marks expire…)
    • Changes in ISO 13485:2016, now externally audited via MDSAP
  • Been looming for some…
    • Canadian SOR-98-282 Medical Device Regulations now underpinned by MDSAP,
    • CE Marking
      • EU Medical Device Directives (Articles and Annexes) soon to be overtaken by the Medical Device Regulations,
      • MEDDEVs partially subsumed by the MDRs,
    • 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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