Resources

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

LOG INTO RAMS

What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
Read More
Introduction to Brazil's Medical Device Approval Process
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
Read More
In Depth: Brazil Medical Device Approval and Compliance
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
Read More
Introduction to Canada's medical device registration process
Canada is a well-established but lucrative market for medical devices. It has one-fifth the population of Brazil, but spends nearly as much on
Read More
ISO 13485:2016: Six Key Differences for Medical Device Companies
The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others
Read More
China Medical Device Market Overview
With over 1.3 billion residents, China has one of the world's largest medical device markets. Medical device manufacturers around the world are
Read More
Introduction to Colombia's Medical Device Approval Process
Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This
Read More
Introduction to Clinical Evaluation Reports (CER) for Europe
Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device,
Read More