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…
Give Ian a call or an email if you’d like some more information..