This chart illustrates the steps in the Australia TGA medical device approval process and includes a timeline of expected approval.
This chart illustrates the steps in the Brazil ANVISA IVD approval process and includes a timeline of expected approval.
This chart illustrates the steps in the Brazil ANVISA medical device approval process and includes a timeline of expected approval.
This chart illustrates the steps in the Health Canada medical device approval process and includes a timeline of expected approval.
This two-page chart illustrates the Health Canada approval process for In Vitro Diagnostic devices (IVDs)
This two-page chart illustrates the NMPA medical device approval process in China.
This chart illustrates the steps in the Colombia INVIMA medical device approval process and includes a timeline of expected approval.
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.
This chart illustrates the steps in Europe's IVD approval process and includes a timeline of expected approval.
This chart illustrates steps to CE Marking in Europe's Medical Devices Regulation (MDR 2017/745) approval process.
This chart illustrates the steps in Europe's medical device approval process and includes a timeline of expected approval.
In this two-page chart, get a quick overview of the European CE Marking process for IVDs under the IVDR.
This chart illustrates the steps in the Hong Kong MDCO medical device approval process and includes a timeline of expected approval.
This chart illustrates the steps in India's medical device approval process and includes a timeline of expected approval.
The two-page chart illustrates the PMDA approval process in Japan and is available for download in PDF format.
This chart illustrates the steps in Malaysia's MDA medical device approval process and includes a timeline of expected approval.
This chart illustrates the steps in Mexico's medical device and IVD approval process and includes a timeline of expected approval.
This chart illustrates the steps in Russia's medical device approval process and includes a timeline of expected approval.
The chart shown illustrates the Saudi Arabia approval process and is available for download in PDF format.
This chart illustrates the steps in Singapore's HSA medical device approval process and includes a timeline of expected approval.