As originally asked by Alan Leitch.

Just looking for names and experinces where you have a third party independent do your device registrations so you maintain a degree of leverage with distributors, thanks.

Peter Chang
Senior Director Regulatory Affairs, Solta Medical, Inc., Valeant Pharma
Try Pacific Bridge Medical, Ames Gross.

Afonso Sanz
Innovative, creative and articulate multi-task professional
Hello Alan,

The only way that you have to applying for product registration in Latin America countries, and not loose your PR is, registering your products under a sister company name (DBA). That way you have your rights of distribution protected by law and no possibility of PR losses. Specialized companies in regulatory issues are available, but I suggest you to do a serious research, before hiring their services. Be prepared to spend some time and money. The approval processes might take from one up to two year period.

Tzahi Zagorski
Medical Devices Specialist – Business, Projects, Product expert, Technical, Applications, Service, Support
Alan,
I wonder why you wish to do that.
If you have a distributor you cannot rely on, you’d better stop all cooperation with them.
If you don’t have a distributor to market your products in a certain region, than what’s the point of registering your products there?

FREDERICO MIRANDA
CONSULTOR FARMACÊUTICO | ASSUNTOS REGULATÓRIOS | GARANTIA DE QUALIDADE | LOGÍSTICA
Dear All,
In Brazil we have a company with extensive experience in product registration at ANVISA.
f[email protected]
Regards,

Tony Liu
Marketing at XinChen Hardware & Plastic Products Company
I think you’d better do some forecast and apply the licenses on you target foreign countries early.

Alan Leitch
Regulatory Specialist at Optos
Hi Jerrold, did Intertek help out with actual country registrations?
Thanks for taking the time to reply to me.

Jerrold Shapiro
President and CEO, Fem-Medical LLC
Alan, I also talked to the Emergo Group, who seem knowledgeable. They offer representation in ten countries in South America. For details, go to [http://www.emergogroup.com/services/south-america|leo://plh/http%3A*3*3www%2Eemergogroup%2Ecom*3services*3south-america/Lp1Y?_t=tracking_disc]

Another company with representation in nine countries in South America is Intertek. One of their sales people has served on the Medical Development Board with me for several years, and has been very helpful in teaching me about securing the CE Mark. For details, go to [http://www.intertek.com/contact/americas/northandsouthamerica/|leo://plh/http%3A*3*3www%2Eintertek%2Ecom*3contact*3americas*3northandsouthamerica*3/4idm?_t=tracking_disc]

Alan Leitch
Regulatory Specialist at Optos
HI Christoph, thanks for your comments, I was actually looking for companies who provide services for Latin American and Middle East Registrations. I too have experience with Emergo, we are just looking to have a variety of service providers (if possible?)

Christoph Janott
Sales Director DACH at DistalMotion SA
Hi Alan, you might check for those companies that act as EU authorized representative for non-EU manufacturers, they usually have knowledge in registrations. I have good experience with Emergo – but there are several others around.