Colombia Authorized Representative (AR)

Foreign manufacturers that do not have a legal entity in Colombia must appoint a local Legal Representative, also known as the Sanitary Registration Holder (SRH), before they can market medical devices in the country. The registration process is regulated by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Colombia's National Institute for Food and Drug Surveillance.

Acting as your official representative, the Colombia Authorized Representative (AR) manages regulatory interactions with INVIMA and ensures your products remain compliant with Colombian medical device regulations throughout their lifecycle.

By appointing an experienced Colombia Legal Representative, manufacturers can confidently expand into the Colombian market while ensuring a smooth registration process and long-term regulatory compliance. Contact us to learn how Qserve can support your market entry in Colombia by acting as your Legal Representative and managing your regulatory requirements.

Liaison with INVIMA

Your Colombia AR serves as the primary point of contact between your company and INVIMA. They manage all regulatory communications, respond to requests for additional information, and ensure that interactions with the authority are handled efficiently and in accordance with local regulatory requirements.

Registration

The AR is responsible for managing the product registration process and acts as the holder of the Registro Sanitario (Marketing Authorization) on your behalf. By holding the registration, they enable your products to be legally placed on the Colombian market while helping you maintain market independence and regulatory continuity.

Documentation

All documentation submitted to INVIMA must be prepared in Spanish and comply with the authority's regulatory requirements. The Colombia AR coordinates the preparation and submission of the registration dossier, supports any requests for clarification during the review process, and facilitates communication until approval is granted. Once issued, the Registro Sanitario is generally valid for ten years, after which it must be renewed to maintain market access.

Compliance

Following product approval, the Colombia AR continues to support your regulatory obligations by ensuring ongoing compliance with INVIMA regulaotry requirements. This includes coordinating post-market surveillance activities, managing technovigilance reporting, and supporting product recalls or other corrective actions whenever necessary.