In most major markets the path to medical device regulatory approval is well documented. The process may not be easy, but it is well understood. That’s not true in all countries, especially some countries in Latin America, Southeast Asia, Africa and the Middle East.
Medical device companies seeking to enter these smaller markets often engage Emergo to determine the regulatory requirements for their products and/or determine if any regulatory controls apply at all. Doing so is an essential first step toward creating a viable market entry strategy.
Understand the regulatory process applicable to your medical device
Emergo works with thousands of medical device companies worldwide, making a vast array of devices. We also have offices and experienced consultants in 25 countries worldwide. Our geographic reach means we have knowledge of the regulatory requirements in smaller regional markets.
From Algeria to Zambia, we provide custom Regulatory Pathway Reports to our clients for almost every country in the world, including these markets where the regulatory process (if applicable) is not well understood or documented:
- El Salvador
Regulatory pathway report options for medical devices
Our consultants will customize each report for your devices, but they can be further expanded to meet your specific needs. Our reports get right to the point and skip the fluff. Typically, they are fewer than 10 pages per country but packed with valuable insight. In markets with established regulatory systems, our reports typically cover:
- Overview of the local regulatory framework
- An assessment of your product
- Classification of your device
- Local requirements for representation
- Quality system documentation requirements, if any
- Medical device registration* requirements for YOUR device
- Leveraging of existing major market approvals
- Pre-clinical and clinical data requirements
- Labeling requirements
- Anticipated costs and timelines to approval
- Local post-market surveillance processes
Please contact us for more information about our custom Regulatory Pathway Reports.
* Although we provide regulatory reports for the markets listed above, Emergo is unable to provide assistance with device registration in these specific markets. We can, however, assist with distributor search services.