Colombia Registro Sanitario Renewal: Deadlines, Fees and Missed-Window Consequences

1. Key takeaways

In Colombia, the Registro Sanitario for a medical device is valid for 10 years, counted from the date of the administrative act that grants it. A renewal application must be filed at least 3 months before the expiry date; in vitro diagnostics follow a separate rule under Decreto 3770 de 2004, which applies to filings made within the 6 months preceding expiry. Missing the window is not a matter of paying a late fee: the administrative act expires, the product loses its legal right to be marketed, and the dossier can only be re-submitted as a new registration, with the full fee paid again at the rates set by Resolución 2025067543 — Class I/IIa at 321.91 UVB, approximately COP 3,898,330, and Class IIb/III at 364.36 UVB, approximately COP 4,413,000.

GRZAN’s position is that renewal should be treated as a project launched 12 months in advance, not as paperwork handled just before expiry. Out of the full 10-year term, the only window reserved for the actual filing action is the final 3 months; what the previous 9 years demand is keeping the information recorded on the certificate consistent with reality. Otherwise the renewal ends up stacked on top of change notifications, and a single process turns into two.

2. Legal basis

3. Expert insights

1. The countdown starts on the date of the administrative act, not the printing date of the certificate

The validity period runs from the date of the administrative act granting the registration, and this single sentence fixes where the renewal countdown begins. GRZAN has seen two recurring misreadings in practice: treating the date printed on the certificate as the starting point, or treating the date the product first entered Colombia as the starting point. Both calculations put the countdown out of alignment. The correct approach is to retrieve the granting date of the administrative act directly in SIRIS and build the renewal ledger on that date.

2. The 3-month window is back-calculated from official review timelines

Under the official review timelines, standard registration takes 90 business days and automatic registration takes 2 business days; the deficiency response period is 90 days (days versus business days is stated inconsistently in public sources, so treat it as a practical estimate), and a single missed response is treated as a suspension. Set these figures next to the rule of at least 3 months before expiry and the logic becomes clear: the window exists to allow one full round of review, deficiency response and re-review before the lapse date. A 90-business-day review period alone consumes most of a 3-month window, so filing right at the edge leaves no margin. Note also that filing a renewal does not automatically extend the validity of the original certificate.

3. IVDs run on a second clock, and the R suffix is the renewal record

IVDs are governed by Decreto 3770 de 2004: Categoría I / II are valid for 10 years and Categoría III for 5 years, with a renewal window of within the 6 months before expiry. This means a Categoría III IVD faces a shorter validity combined with a longer filing window, a rhythm completely different from that of devices. Meanwhile, registration numbers such as INVIMA 2025DM-0002510-R2 carry an R suffix that records the number of renewals; this suffix is frequently cited in tenders and channel admission as part of the compliance record and should be maintained as a separate field in the ledger.

4. Practical recommendations

1. Registration holder (titular): build the renewal ledger using the granting date of the administrative act in SIRIS as the sole reference, with the trigger point set at 12 months before expiry.
2. Chinese manufacturers: define in the POA (Decreto 4725 de 2005, Art. 29) the authority and its term for handling renewal matters, so the authorization does not lapse at the critical moment.
3. Regulatory affairs leads: start a consistency review of the certificate contents 9 months before expiry (the titular name and address recorded under Art. 20).
4. Regulatory affairs leads: file early using a practical estimate of 3 months before expiry for devices and within 6 months before expiry for IVDs, reserving margin for deficiency responses.
5. Finance and commercial teams: budget at the rates of Resolución 2025067543 as partially amended by Resolución 2026033499.
6. Importers: check in parallel the validity of the CCAA (5 years under Resolución 4002 de 2007); the lapse of either document interrupts imports.

5. Verification checklist

• □ The granting date of the administrative act has been confirmed in SIRIS and the expiry date calculated from it
• □ The two validity regimes have been distinguished (devices 10 years; IVDs Categoría I / II 10 years, Categoría III 5 years)
• □ Renewal filings are scheduled using a practical estimate of 3 months before expiry for devices and within 6 months for IVDs, with margin reserved for deficiency responses
• □ The POA (Art. 29) has been confirmed valid on the filing date and throughout the review period
• □ The titular name and address (Art. 20) have been checked against current reality
• □ The R suffix of the registration number (renewal count) has been recorded and can be presented externally as a compliance record

Regulatory information verified as of October 29, 2026

All conclusions published here defer to the current regulatory texts as issued by the competent authority, verified item by item before delivery.

— GRZAN Regulatory Team

GRZAN supports medical device and IVD manufacturers entering and staying on the Colombian market with end-to-end post-market compliance: technovigilance program setup and adverse event reporting, recall and field corrective action execution under INVIMA directives, preparation for follow-up controls and inspections, renewal and change management for the Registro Sanitario, and long-term maintenance of compliance ledgers in SIRIS. For tailored support on your Colombia portfolio, contact the GRZAN regulatory team at info@grzanglobal.com.