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Who do companies use to do medical device registrations in foreign countries if you wish licenses not to be held by a distributor?
< 1 min reading time
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.
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.
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]
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