Colombia: Maintaining and Renewing Registration

Good afternoon, and welcome back to another week of MedTech Compliance Chronicles! Today, we reach the final post in our assessment of Colombia’s medical device regulations, focusing on an essential yet often underestimated aspect of compliance: maintaining and renewing market registration. Securing market authorization is only the first step—ongoing compliance is necessary to ensure that a medical device remains legally available in Colombia. INVIMA enforces strict post-market obligations, requiring manufacturers to renew registrations on time, report relevant changes, and ensure continued compliance with evolving regulatory standards. Failing to meet these obligations can lead to registration lapses, product recalls, or even market removal, creating significant disruptions for manufacturers and distributors.

In this post, we’ll outline the key requirements for maintaining a valid registration, the renewal process, and the responsibilities manufacturers must fulfill to ensure compliance. Whether you’re preparing for renewal or strategizing for long-term market access, understanding these regulatory obligations is crucial for sustaining uninterrupted operations in Colombia’s medical device market.

Medical Device Renewals

Once a company secures health registration and marketing authorization for a medical device, maintaining compliance requires adhering to commercialization and renewal requirements. After registration, companies have 36 months from the date of authorization issuance to begin product commercialization. If commercialization does not commence within this timeframe, the authorization is automatically canceled. If there are justified reasons preventing commercialization, manufacturers must notify INVIMA within one month after the deadline, requesting an extension. INVIMA may grant a one-time extension through a formal resolution, but failure to notify within the required timeframe may result in registration loss.

If a company intends to withdraw a registered product from the market, INVIMA must be notified in advance. For controlled technology biomedical equipment, manufacturers without active representation in Colombia must ensure that technical support remains available throughout the authorization’s validity to guarantee continued post-market service and compliance.

Health registrations and marketing authorizations in Colombia are generally valid for ten years. To prevent market disruptions, manufacturers must submit renewal applications to INVIMA at least three months before the registration expires. If a renewal request is not submitted within this timeframe, the application will be treated as a new registration, requiring a full regulatory review. The renewal process involves the same level of scrutiny as the initial application, with technical and legal evaluations of the product’s quality control, manufacturing process, and compliance with current Good Manufacturing Practices (GMP) standards. If the scientific and technical documentation remains unchanged, manufacturers can submit a formal declaration affirming its continued validity instead of resubmitting all supporting documents.

Products that are not renewed in time must be withdrawn from the market, and any remaining inventory exceeding the permitted disposal period will be subject to confiscation by INVIMA. Ensuring compliance with renewal timelines is essential to avoiding costly interruptions and maintaining continued market access.

In Vitro Diagnostics (IVDs)

The renewal process for in vitro diagnostic (IVD) devices follows a similar framework but has distinct validity periods based on product risk classification. Lower-risk IVDs, classified as Class I and II, have a validity period of ten years, while higher-risk IVDs must be renewed every five years. To avoid market disruptions, renewal applications must be submitted at least six months before expiration.

Like medical devices, renewal applications for IVDs require submission of all technical documentation from the initial application or a formal declaration confirming its continued applicability. Failure to renew within the required timeframe results in an immediate prohibition on further manufacturing and importation of the affected IVD. In certain cases, INVIMA may authorize a six-month disposal period for products that were already distributed before the registration expired. After this period, any remaining stock must be withdrawn from the market to avoid potential regulatory enforcement actions.

Conclusion

Maintaining and renewing medical device and IVD registrations in Colombia requires strict adherence to INVIMA’s regulatory timelines and post-market obligations. Market authorization is not a one-time achievement but an ongoing commitment that involves timely renewals, compliance with commercialization requirements, and proactive regulatory engagement. Manufacturers must ensure continuous oversight of registration deadlines, maintain updated technical documentation, and submit renewal requests well in advance to prevent unnecessary delays.

Failure to comply with registration and renewal requirements can result in market removal, product recalls, or inventory confiscation, all of which can lead to financial losses and reputational harm. By understanding INVIMA’s expectations and integrating compliance into long-term regulatory strategy, manufacturers can ensure uninterrupted market access and continued product availability in Colombia. As we conclude our discussions on Colombian regulations, staying ahead of compliance challenges remains the best strategy for long-term success in this evolving market.