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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

Please get in touch if you wish to discuss any of the contents of this page with one of our consultants at hello@imedconsultancy.com.

Resources

Address:

IMed Consultancy Ltd.

Bloxham Mill Business Centre
Barford Road, Bloxham
Banbury
Oxfordshire
OX15 4FF
United Kingdom

IMed Consultancy Ltd.

G02, 3000, Manchester Business Park Aviator Way, Wythenshawe, Manchester

M22 5TG

Business details

Business No: 08094948

VAT No: 191 4536 01

Email:
hello@imedconsultancy.com

Tel:
+44 (0)1295 724286
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