Regulations

Market	Medical Device Regulation URL
United Kingdom	Medical devices regulation and safety
EU	Medical 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 States	Establishment 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
Canada	Canadian Medical Device Regulation
Australia	Therapeutic Goods (Medical Devices) Regulations 2002
Japan	PMDA Regulations
Brazil	ANVISA Medical Device Regulations
Saudi Arabia	SFDA Medical Device Regulation

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