Category

Medical Devices compliance by market

529 requirement guides for medical devices across 58 markets. Start with the market you sell into.

Argentina

Argentina Medical Device Registration Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Australia

Australia Medical Device Registration Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Austria

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Bangladesh

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Belgium

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Brazil

Brazil Medical Device Registration Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Cambodia

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Canada

Canada Medical Device Licensing Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Chile

Chile Medical Device Registration Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Colombia

Clinical Evidence Colombia Medical Device Registration Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Czechia

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Denmark

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Egypt

Clinical Evidence Device Classification Device Registration Egypt Medical Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

European Union

Clinical Evidence Device Classification Device Import Licence Device Registration EU Clinical Evaluation EU In Vitro Diagnostic Regulation Compliance EU MDR Classification EU MDR Risk Classification EU MDR UDI and EUDAMED EU Post-Market Surveillance EU Vigilance Reporting Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Finland

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

France

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Germany

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Greece

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Hong Kong

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Hungary

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

India

Clinical Evidence Device Classification Device Import Licence Device Registration India Medical Device Licensing Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Indonesia

Clinical Evidence Device Classification Device Import Licence Device Registration Indonesia Medical Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Ireland

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Israel

Clinical Evidence Device Classification Device Registration Israel Medical Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Italy

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Japan

Clinical Evidence Device Classification Device Import Licence Device Registration Japan Medical Device Approval Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Kazakhstan

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Kenya

Clinical Evidence Device Classification Device Registration Kenya Medical Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Malaysia

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Malaysia Medical Device Registration Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Mexico

Clinical Evidence Device Classification Device Registration Labelling and IFU Mexico Medical Device Registration Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Mongolia

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Myanmar

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Netherlands

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

New Zealand

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Nigeria

Clinical Evidence Device Classification Device Registration Labelling and IFU Nigeria Medical Device Registration Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Norway

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Pakistan

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Peru

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Philippines

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Philippines Medical Device Registration Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Poland

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Portugal

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Romania

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Saudi Arabia

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Saudi Medical Device Registration Unique Device Identification Vigilance Reporting

Serbia

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Singapore

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Singapore Medical Device Registration Unique Device Identification Vigilance Reporting

South Africa

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification South Africa Medical Device Licensing Unique Device Identification Vigilance Reporting

South Korea

Clinical Evidence Device Classification Device Import Licence Device Registration Korea Medical Device Approval Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Spain

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Sri Lanka

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Sweden

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Switzerland

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Taiwan

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Thailand

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Thailand Medical Device Registration Unique Device Identification Vigilance Reporting

Türkiye

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

United Arab Emirates

Clinical Evidence Device Classification Device Registration Labelling and IFU Post-Market Surveillance QMS Certification UAE Medical Device Registration Unique Device Identification Vigilance Reporting

United Kingdom

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification UK MDR Registration UKCA Medical Device Marking Unique Device Identification Vigilance Reporting

United States

Clinical Evidence Clinical Laboratory Improvement Amendments De Novo Classification Device Classification Device Import Licence Device Registration Establishment Registration and Device Listing FDA 510(k) Clearance FDA Medical Device Recall FDA Premarket Approval Labelling and IFU Medical Device Reporting Post-Market Surveillance QMS Certification Unique Device Identification Vigilance Reporting

Vietnam

Clinical Evidence Device Classification Device Import Licence Device Registration Labelling and IFU Post-Market Surveillance QMS Certification Unique Device Identification Vietnam Medical Device Registration Vigilance Reporting

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