A keynote speaker at FIME, Richard Vincins is vice president of quality and regulatory affairs at Emergo. The Texas-based consulting firm assists and advises medical device companies from the quality system implementation perspective to the regulatory requirements such as submissions and registrations. Vincins shared with us his views on FIME and the regulatory environment in Latin America.
MedicalExpo e-mag: What do you cover at FIME?
Richard Vincins: In years past, I used to just give the one presentation on global regulations, but as people kept asking questions about different countries, the one hour of allotted time really was not sufficient. So last year I actually separated it. So the global-regulation portion talks about the main countries outside of Latin America—the United States, Canada, and Japan, European Union and Australia. My second presentation focuses on Latin America with primary attention on the countries that have regulations such as Brazil, Argentina, Colombia and Chile. This is an overview of their regulations, how a company can get to market.
ME e-mag: What is the landscape in the major Latin American countries?
Richard Vincins: Some countries still don’t have a good regulatory system so a lot of the information we talk about during the presentation is helping them understand some of the basic requirements, how devices are classified in those countries, what the regulatory agency is that would review applications. I let them know if the country they’re interested in accepts alternative regulatory approvals. For example, if your device is registered in the United States it would be an easier pathway to get registration in these countries.
ME e-mag: Are there some other pointers you could share about entering the Latin American countries?
Richard Vincins: Probably the biggest thing is having somebody locally that can navigate or assist with the regulations. So, as an example, at Emergo we have an office in Costa Rica. We have an office in Argentina. We have an office in Brazil. Speaking the local language and understanding the local requirements goes a long way.
The second point is that having home-country approval can provide leverage in getting approval in the new markets. So if the company is based in the United States or European Union it’s better to get the local approval before venturing into Latin America because it can be a long process.
ME e-mag: What difference does that make?
Richard Vincins: It can save them quite a few months, actually. So, rather than looking at 12 months for a registration process, they could maybe be looking at half that time.
Speaking the local language and understanding the local requirements goes a long way.
ME e-mag: Are there any regulatory trends you can point to in Latin American countries?
Richard Vincins: Many countries are implementing new regulations. It’s not a matter of changing regulations as much as new regulations are being put into place with for product registrations. As an example, Colombia and Peru have revised regulations in the last couple of years and they’re almost new regulations for what medical-device companies have to do to get into those countries or register their products. Some countries in Latin America do not have any regulations. Or if they have regulations they’re from the 1960s or 1970s.