Differences and Similarities in Sanitary Registration Across Latin America

Across Latin America, sanitary registration processes share an underlying logic, and that has allowed the region’s agencies to bring their criteria closer, above all on the type of information provided in applications. Even so, each country keeps its own particularities, and those particularities are what define who owns a registration, how a product is classified and how long it takes to obtain.

What is alike across countries

The most important overlap is also the most basic: in the region, a regulated product needs a health authorization before it can be marketed. On that common base, the agencies have gradually brought some criteria closer, in particular the type of technical and legal documentation required for applications. For a company planning to enter several markets, that convergence makes it easier to reuse part of the dossier from one country to another.

What changes from one country to another

The differences begin right where that common base ends. Three of them weigh most when planning a regional registration:

• Ownership: who can be the holder of the registration changes from one country to another. In some, only the importer can be; in others, a local company that takes on the registration in place of the foreign manufacturer; and in others it is possible to own the registration without local representation.
• Classification: the same product may land in a different category or risk level depending on the country, which changes the requirements and the rigor of the procedure.
• Timelines: the time it takes to obtain approval varies significantly by agency and type of product.

That is why it is best not to assume that what applies in one country applies the same way next door. Each country-specific requirement should be verified with its authority before filing the application.

A reference point: Colombia

Colombia helps ground the picture. Here the health authority is INVIMA, and regulated products need its authorization to be manufactured, imported or marketed. A particular trait of the country is that it is indeed possible to hold a sanitary registration without local representation. As for validity, for example, a medical device’s sanitary registration runs for 10 years for all risk classes (Decreto 4725 de 2005, Decree 4725 of 2005). That kind of detail, the validity, the holder, the classification, is what changes from one country to another.

The Free Sale Certificate, the key to crossing borders

When a product is already authorized in its country of origin and seeks registration in another, the Certificado de Libre Venta (CLV), or Free Sale Certificate, usually comes into play. It is the document with which the health authority of the country of origin certifies that the product is legally marketed there. In Colombia it is issued by INVIMA, and across the region it is one of the supporting documents that authorities frequently request within the registration dossier.

Knowing the details of each country is what makes it possible to map the right route and avoid delays. At SPI Américas we support the management of sanitary registrations in Colombia and across Latin America. If you have questions, write to us at [email protected] and let’s find the best option for your company together.