Regulations

MarketMedical Device Regulation URL
United KingdomMedical devices regulation and safety
EUMedical Device Directive 93/42/EEC
Active Implantable Medical Device Directive 90/385/EEC
In-Vitro Diagnostic Directive 98/79/EC
In-Vitro Diagnostic Regulation 2017/746
Medical Device Regulation 2017/745
United StatesEstablishment Registration - 21 CFR Part 807
Medical Device Listing - 21CFR Part 807
Premarket Notification 510(k) - 21 CFR Part 807 Subpart E
Premarket Approval (PMA) - 21 CFR Part 814
Investigational Device Exemption (IDE) - 21CFR Part 812
Quality System Regulation (QS regulation) - 21 CFR Part 820
Labeling - 21 CFR Part 801
Medical Device Reporting - 21 CFR Part 803
CanadaCanadian Medical Device Regulation
AustraliaTherapeutic Goods (Medical Devices) Regulations 2002
JapanPMDA Regulations
BrazilANVISA Medical Device Regulations
Saudi ArabiaSFDA Medical Device Regulation

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