Colombia Post-Market Compliance Calendar 2026-2027: Key Dates and Actions

1. Key takeaways

This calendar covers the 12 months from November 2026 through October 2027. Before it begins, several decisive milestones have already passed: the final tier of the transition period in Article 15 of Resolución 1405 de 2022 expired on February 8, 2026; INVIMA confirmed on March 12, 2026 that semantic reporting is fully mandatory; Resolución 2025067543 (published December 22, 2025) was partially amended by Resolución 2026033499 (June 30, 2026); and the draft decree for the new device regime completed its WTO international notification on May 18, 2026, with the comment period closing on July 17, 2026.

GRZAN’s conclusion is that the main theme of the next 12 months is not reacting to new rules but maintaining well the obligations that have already taken effect. Semantic reporting, renewal windows, vigilance duties and ledger consistency make up the entire workload; the landing of the draft decree is the only uncertain variable, and it is more likely to reshuffle pathways than to add obligations.

2. Legal basis

3. Expert insights

1. November 2026 to January 2027: closing semantic reporting gaps and re-checking fee budgets

Verify the semantic reporting status of every product on sale in SIRIS, item by item; do not schedule shipments or tenders for uncompleted products. At the same time, re-check budgets against Resolución 2025067543 as amended by Resolución 2026033499, using 321.91 UVB for Class I/IIa and 364.36 UVB for Class IIb/III. GRZAN’s judgment is that the best investment in this phase is not new projects but clearing the installed base — Chinese manufacturers hold approximately 61,000 records in the Colombian registration database (third-party statistics), and the size of that installed base dictates the order of cleanup.

2. February to April 2027: re-sorting the renewal ledger and the IVD expiry wave

The device renewal window is at least 3 months before expiry; for IVDs it is within the 6 months before expiry. Device validity is uniformly 10 years, while IVD Categoría III lasts only 5 years; the two rhythms differ and the ledgers must be kept separate. The action is to list every registration number expiring within the next 12 months and plan filing dates backward from each expiry. Schedule Class I/IIa automatic renewals on the conservative figure of about 30 days; do not plan production around the 3-business-day figure.

3. May to July 2027: the observation window for the draft decree

The draft decree completed its WTO international notification on May 18, 2026 and the comment period closed on July 17, 2026; as of the verification date it has not been signed or published, and Decreto 4725 de 2005 and Decreto 3770 de 2004 remain the laws in force. The draft’s directions include three-tier authorization, validity linked to post-market performance, ISO 13485 named explicitly as the device GMP standard, a reliance mechanism on the assessment results of foreign regulators such as the FDA, EMA and ANVISA, a unified framework for IVDs and SaMD, UDI moved to the initial application, and a self-proposed 18-month transition period. GRZAN’s position is: add no investment during the observation window, but complete two preparations — confirm where each product sits and fold the UDI-DI into master data.

4. August to October 2027: internal audit of the vigilance system and evidence retention

Audit the vigilance system internally against Resolución 4816 de 2008: the 72-hour serious adverse event reporting ledger, quarterly periodic reports and zero report records, the recall SOP and distribution records, and patient implant cards for implantable devices (Decreto 4725 de 2005, Art. 40). The value of this system shows itself in the follow-up control (Article 57 of Ley 962 de 2005, within 15 days after issuance) and in ex-post verification — whether evidence can be produced quickly at that moment depends on whether it was maintained all along.

4. Practical recommendations

1. Registration holder (titular): complete a full verification of semantic reporting status in SIRIS from November 2026 and suspend shipment and tender plans for uncompleted products.
2. Regulatory affairs leads: export the expiry list using a practical estimate of 3 months before expiry for devices and within 6 months for IVDs, with filing dates planned backward.
3. Finance and commercial teams: build the 2027 budget at the current rates of Resolución 2025067543 / 2026033499.
4. Regulatory affairs leads: schedule Class I/IIa automatic renewals on the conservative figure of about 30 days; do not adopt the 3-business-day figure.
5. Chinese manufacturers: confirm where each product sits in the draft’s three-tier authorization structure and fold the UDI-DI into product master data.
6. Vigilance responsible person: operate the 72-hour reporting countdown ledger and the quarterly periodic reporting mechanism, including a zero-report process.

5. Verification checklist

• □ The semantic reporting status of all products on sale has been verified and uncompleted products suspended from shipment and tender
• □ The expiry list for the next 12 months has been exported, with devices and IVDs managed in separate ledgers
• □ Class I/IIa automatic renewals are scheduled on the conservative figure of about 30 days
• □ The 2027 budget has been built at the current rates
• □ Each product’s place in the draft’s three-tier authorization structure has been confirmed and the UDI-DI folded into master data
• □ The 72-hour reporting ledger and the quarterly periodic reporting mechanism are operating

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 keeps device manufacturers compliant on the Colombian market across the whole post-market cycle: technovigilance and adverse event reporting, recalls and field corrective actions, follow-up control and inspection response, renewals and changes in SIRIS, and forward planning against the incoming decree. To put this calendar into an executable plan, contact the GRZAN regulatory team at info@grzanglobal.com.