Each medical device must be classified according to the health risk it represents. We evaluate your product according to INVIMA Resolution 4002 of 2007 , identifying whether it belongs to Class I, IIa, IIb or III, and determine the specific approval requirements applicable. This allows you to understand the necessary steps and avoid delays due to lack of documentation.

Approval requires a detailed technical file. We advise on the collection and validation of key documents, including ISO 13485 certificates of conformity, clinical studies, biocompatibility tests and risk analysis , ensuring that your product meets international standards and is approved without complications.

We take care of all the document and administrative management with INVIMA, including registration in the Medical Device Information System (SISMID) . We continuously monitor your process, manage responses to requests and guarantee an error-free submission that speeds up the approval process.

For high-risk devices, such as implants, prostheses, life-support devices and electromedical equipment , we manage the clinical studies and performance tests required by INVIMA. We collaborate with certified laboratories to ensure that the tests meet the required safety and efficacy criteria.

Homologation does not end with INVIMA approval. We offer a comprehensive post-marketing management service, ensuring that your product continues to comply with regulatory requirements, avoiding sanctions and guaranteeing permanence in the market. We also manage health registration renewal processes and adverse event reporting.