LATIN AMERICA
Colombia
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.
Language
Submission file needs to be set up in Spanish and even for professional use part of the information needs to be in Spanish.
LATIN AMERICA
Brazil
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 751/2022, applicable since March 1st, 2023, is the primary regulation applicable to the registration of all medical devices. It describes the device registration protocol and lists the documents required to legally register a medical device in Brazil. The Brazilian risk-based classification is subdivided into four classes: I (low risk), II (medium risk), III (high risk), and IV (maximum risk). Medical devices from risk class I/II are submitted to ANVISA using the Notification process (“Notificação”), which requires that fewer documents are sent to the agency and does not need revalidation. However, those devices still must have the full technical dossier completed before submission, and it is subject to review under audit and possible revocation of the market. Medical devices from risk class III/IV are submitted to ANVISA using the Registration process (“Registro”), which requires that the full technical dossier is subject to the assessment of experts with rounds of answers and questions. In addition, those devices must be revalidated every 10 years.
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. The “(Notification or Registry) Holder” is the actual responsible for the medical device in Brazilian territory and holds its commercialization after released by ANVISA. This legal entity can be the manufacturer or the importer and must be the one in the labeling.
Language
Submission documentation can be set up in Portuguese, English, or Spanish, but the label and IFU must be written in Portuguese.