Being the registration holder itself, or having a company specialized in hosting these registrations in markets where it operates is strategic for any manufacturer of Medical Devices. In Brazil, it is fundamental to have a competent and reliable company that can defend the manufacturer’s interests with ANVISA regarding regulatory issues. An eventual dispute of commercial interests between distributors and the manufacturer can result in the loss of ‘’marketshare’’ by having to stay months or even years off the market until registration are reestablished.
Since 1995, acting as consultants in regulatory matters, we have seen it all. Companies that were expelled from competition by purchasing the distributor in Brazil who was the registration holder for the entire product line of their main competitor, commercial conflicts that resulted in the cancellation of registrations and also companies that act as registration holders, but are more bureaucratic than ANVISA and make the simple issuance of an import authorization letter a barrier to the commercialization of products.
It is for these and other situations that changes the daily routine of foreign manufacturers in a real challenge that the BRISA ADVISORS group – through its host registration company BIHS – launched the service of Business Process Outsourcing-BPO – which includes a full service through a simple service subscription. It is the embodiment of the One-Stop Shop term, with the advantage of previsibility of the annual budget that the subscription club model provides.
To promote these services, we will publish the main doubts of our clients regarding different topics, starting with transferring ownership of registrations that allows you to guarantee and maintain access to the market safely and quickly!
Brazilian legislation allows registers to be transferred to another company for reasons of corporate operations such as merger, spin-off, incorporation or even for the sale of assets.
RDC No. 102/2016 which deals with transferring ownership of products subject to Sanitary Surveillance regulated the commercial operation defined as ‘’operation between companies resulting in the sale of assets or group of assets, without the occurrence of any corporate operation between the companies involved.’’
For more information on the subject, visit our FAQ on the subject.
