25 total results. Show all resources.
Australia | MedTech

Australia TGA Regulatory Approval Process for Medical Devices

This chart illustrates the steps in the Australia TGA medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
Brazil

Brazil ANVISA Regulatory Approval Process for IVDs

This chart illustrates the steps in the Brazil ANVISA IVD approval process and includes a timeline of expected approval.

2 pages
Jul 21, 2016
Brazil

Brazil ANVISA Regulatory Approval Process for Medical Devices

This chart illustrates the steps in the Brazil ANVISA medical device approval process and includes a timeline of expected approval.

2 pages
Jul 21, 2016
Canada

Health Canada Regulatory Approval Process for Medical Devices

This chart illustrates the steps in the Health Canada medical device approval process and includes a timeline of expected approval.

2 pages
Aug 10, 2016
Canada | MedTech

Health Canada Regulatory Approval Process for IVDs

This two-page chart illustrates the Health Canada approval process for In Vitro Diagnostic devices (IVDs)

2 pages
Aug 10, 2016
China | MedTech

China NMPA Regulatory Approval Process for Medical Devices

This two-page chart illustrates the NMPA medical device approval process in China.

2 pages
Dec 5, 2016
Colombia

Colombia INVIMA Medical Device Regulatory Approval Process

This chart illustrates the steps in the Colombia INVIMA medical device approval process and includes a timeline of expected approval.

2 pages
Oct 28, 2016
Costa Rica | MedTech

Costa Rica medical device & IVD approval process

Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a few pathways to approval, and documentation requirements are different depending on your device's class.

2 pages
Jun 3, 2015
Europe | MedTech

Europe In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process

In this two-page chart, get a quick overview of the European CE Marking process for IVDs under the IVDR.

2 pages
Aug 20, 2019
Europe | MedTech

European IVD Regulatory Approval Process

This chart illustrates the steps in Europe's IVD approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
Europe | MedTech

Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process

This chart illustrates steps to CE Marking in Europe's Medical Devices Regulation (MDR 2017/745) approval process.

2 pages
Aug 23, 2017
Europe | MedTech

Europe CE Marking Regulatory Process for Medical Devices

This chart illustrates the steps in Europe's medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
Hong Kong

Hong Kong Approval Process for Medical Devices

This chart illustrates the steps in the Hong Kong MDCO medical device approval process and includes a timeline of expected approval.

1 page
Aug 17, 2015
India | MedTech

India Approval Process for Medical Devices & IVDs

This chart illustrates the steps in India's medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
Japan | MedTech

Japan Regulatory Approval Process for Medical Devices

The two-page chart illustrates the PMDA approval process in Japan and is available for download in PDF format.

2 pages
Aug 29, 2013
Malaysia

Malaysia Regulatory Approval Process for Medical Devices

This chart illustrates the steps in Malaysia's MDA medical device approval process and includes a timeline of expected approval.

2 pages
Apr 16, 2015
Mexico

Mexico COFEPRIS Regulatory Approval Process for Medical Devices and IVDs

This chart illustrates the steps in Mexico's medical device and IVD approval process and includes a timeline of expected approval.

2 page chart
Jul 21, 2016
Russia

Russia Approval Process for Medical Devices

This chart illustrates the steps in Russia's medical device approval process and includes a timeline of expected approval.

2 pages
Jul 19, 2016
Saudi Arabia | MedTech

Saudi Arabia Regulatory Approval Process for Medical Devices

The chart shown illustrates the Saudi Arabia approval process and is available for download in PDF format.

2 pages
Aug 29, 2013
Singapore | MedTech

Singapore Regulatory Approval Process for Medical Devices

This chart illustrates the steps in Singapore's HSA medical device approval process and includes a timeline of expected approval.

2 pages
Jun 3, 2015
South Korea | MedTech

South Korea MFDS Regulatory Approval Process for Medical Devices

This chart illustrates the steps in South Korea's MFDS medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
Taiwan

Taiwan TFDA Regulatory Approval Process for Medical Devices & IVDs

This chart illustrates the steps in Taiwan's TFDA medical device approval process and includes a timeline of expected approval.

2 pages
Sep 19, 2016
United States | MedTech

US FDA Registration Process for Medical Devices and IVDs

This chart illustrates the steps in the US FDA's medical device approval process and includes a timeline of expected approval.

2 pages
Jan 1, 2015