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Medical device classification, country by country.

Choose a market, describe your device, and get a preliminary risk class with a clear explanation, official source links, and similar registered products where available.

37 country classifiers5 global regions

Current official requirements

Each result includes links to the regulator or government sources used.

Similar registered products

Where available, see comparable devices already registered in that market.

A result you can review

See the suggested class, why it may apply, and what to confirm next.

Choose a target country

Open a country tool to check your device against that market's classification system. Every classifier is free and requires no account.

Americas

9 classifiers

Argentina

ANMAT

Describe your device and get a preliminary ANMAT risk class with an explanation and source links.

Open free classifier

Brazil

ANVISA

Describe your device and get a preliminary ANVISA risk class with an explanation and source links.

Open free classifier

Canada

Health Canada

Describe your device and get a preliminary Health Canada risk class with an explanation and source links.

Open free classifier

Colombia

INVIMA

Describe your device and get a preliminary INVIMA risk class with an explanation and source links.

Open free classifier

Cuba

CECMED

Describe your device and get a preliminary CECMED risk class with an explanation and source links.

Open free classifier

Ecuador

ARCSA

Describe your device and get a preliminary ARCSA risk class with an explanation and source links.

Open free classifier

Mexico

COFEPRIS

Describe your device and get a preliminary COFEPRIS risk class with an explanation and source links.

Open free classifier

Peru

DIGEMID

Describe your device and get a preliminary DIGEMID risk class with an explanation and source links.

Open free classifier

United States

FDA

Describe your device and get a preliminary FDA risk class with an explanation and source links.

Open free classifier

Europe

7 classifiers

Albania

AKBPM

Describe your device and get a preliminary AKBPM risk class with an explanation and source links.

Open free classifier

Belarus

Ministry of Health

Describe your device and get a preliminary Ministry of Health risk class with an explanation and source links.

Open free classifier

European Union

EU MDR

Describe your device and get a preliminary EU MDR risk class with an explanation and source links.

Open free classifier

Russia

Roszdravnadzor

Describe your device and get a preliminary Roszdravnadzor risk class with an explanation and source links.

Open free classifier

Serbia

ALIMS

Describe your device and get a preliminary ALIMS risk class with an explanation and source links.

Open free classifier

Turkey

TITCK

Describe your device and get a preliminary TITCK risk class with an explanation and source links.

Open free classifier

United Kingdom

MHRA

Describe your device and get a preliminary MHRA risk class with an explanation and source links.

Open free classifier

East Asia & Pacific

7 classifiers

Australia

TGA

Describe your device and get a preliminary TGA risk class with an explanation and source links.

Open free classifier

China

NMPA

Describe your device and get a preliminary NMPA risk class with an explanation and source links.

Open free classifier

Hong Kong

MDD

Describe your device and get a preliminary MDD risk class with an explanation and source links.

Open free classifier

Japan

PMDA

Describe your device and get a preliminary PMDA risk class with an explanation and source links.

Open free classifier

Macau

ISAF

Describe your device and get a preliminary ISAF risk class with an explanation and source links.

Open free classifier

South Korea

MFDS

Describe your device and get a preliminary MFDS risk class with an explanation and source links.

Open free classifier

Taiwan

TFDA

Describe your device and get a preliminary TFDA risk class with an explanation and source links.

Open free classifier

South & Southeast Asia

10 classifiers

Bangladesh

DGDA

Describe your device and get a preliminary DGDA risk class with an explanation and source links.

Open free classifier

India

CDSCO

Describe your device and get a preliminary CDSCO risk class with an explanation and source links.

Open free classifier

Indonesia

Ministry of Health

Describe your device and get a preliminary Ministry of Health risk class with an explanation and source links.

Open free classifier

Malaysia

MDA

Describe your device and get a preliminary MDA risk class with an explanation and source links.

Open free classifier

Myanmar

FDA Myanmar

Describe your device and get a preliminary FDA Myanmar risk class with an explanation and source links.

Open free classifier

Pakistan

DRAP

Describe your device and get a preliminary DRAP risk class with an explanation and source links.

Open free classifier

Philippines

FDA Philippines

Describe your device and get a preliminary FDA Philippines risk class with an explanation and source links.

Open free classifier

Singapore

HSA

Describe your device and get a preliminary HSA risk class with an explanation and source links.

Open free classifier

Thailand

Thai FDA

Describe your device and get a preliminary Thai FDA risk class with an explanation and source links.

Open free classifier

Vietnam

Ministry of Health

Describe your device and get a preliminary Ministry of Health risk class with an explanation and source links.

Open free classifier

Middle East & Africa

4 classifiers

Israel

AMAR

Describe your device and get a preliminary AMAR risk class with an explanation and source links.

Open free classifier

Saudi Arabia

SFDA

Describe your device and get a preliminary SFDA risk class with an explanation and source links.

Open free classifier

South Africa

SAHPRA

Describe your device and get a preliminary SAHPRA risk class with an explanation and source links.

Open free classifier

Tanzania

TMDA

Describe your device and get a preliminary TMDA risk class with an explanation and source links.

Open free classifier

Use the result as a starting point

Your final classification depends on the complete intended use, product design, and the requirements of the target market. Review the source links, then confirm the pathway before filing.

Browse all country resources →How the tools work →

DJ Fang

MedTech Regulatory Expert

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