The medical device regulatory environment in the main Latin American countries has been changing rapidly converging with international regulations.
Most manufacturers seek the Latin American markets once they have gotten the CE mark or FDA clearance.
We will discuss about overview of device regulations/all classes in the main Latin American markets analyzing the complexity of the regulatory approval process/country specific which is directly linked to the medical device classification.
In the medical device research and development sector, Latin American investigators and key opinion leaders have been playing an important role in clinical trial participation such as with obesity devices, stents, intraocular devices, etc.
The medical devices landscape in Latin America will be discussed from two perspectives:
The regulatory environment to ensure safety, efficacy for product registration, and The opportunities, challenges and solutions for companies interested in entering the Latin American markets.
Andréa Saud Martinez, M.Sc.,Pharm.D
Chief Director, Clinical Research
Avanti Pesquisa Clínica