The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) is the authority responsible for medical device vigilance and quality control following Decree 4725/2005. The Colombian classification system is a risk based classification (Chapter II of Decree 4725/2005) and is subdivided in four classes (Class I, Class IIa, Class IIb and Class III), similar to the classification used in Europe. After submission is done and accepted by INVIMA, the manufacturer will receive a Sanitary Registry number that should be placed on the product label. One of the important documents that needs to be provided is the Free Sales Certificate (FSC) issued by the competent sanitary agency in the country of origin, legalized through consulate or apostille.
Local license holder
Companies without an establishment in Colombia are required to appoint a Colombian local representative. Both the importer as a separate Colombian legal representative can act as the local registration partner. The importer should be known at the moment of registration as an authorization document for import is part of the submission file.
Submission file needs to be set up in Spanish and even for professional use part of the information needs to be in Spanish.
The Agência Nacional de Vigilância Sanitária (ANVISA) is the National Health Surveillance Agency taking care of the registration of medical devices and maintenance of a registered products database and the Brazilian GMP audit. RDC 185/01 is the primary regulation applicable to the registration of all medical devices, the risk based classification is subdivided in four classes similar to the Annex IX 93/42/EEC. RDC No.185 describes the applicable device registration protocol and lists the documents required to legally register a medical device in Brazil. Not all product registrations require a GMP certification, this depends on classification of the medical device and also on which part of the manufacturing procedure takes place in Brazil.
Local license holder
Companies without an establishment in Brazil are required to appoint a Brazilian Registration Holder (BRH). This BRH can be another company as your distributor holding your certificate and giving permission to distributors to import your product. The BRH will coordinate inquiries and take care of reportable events and recalls. They assist in renewals and modifications of device registrations.
Submission file needs to be set up in Portuguese and label and IFU need to be in Portuguese.