INVIMA Joins IMDRF as Affiliate Member: Implications

1. Key takeaways

At the 28th meeting of the IMDRF Management Committee, held in Sapporo, Japan on September 18–19, 2025, INVIMA was approved as an Affiliate Member of the International Medical Device Regulators Forum (IMDRF). This is not a ceremonial status; it is a public commitment by the Colombian regulatory system to external alignment.

The GRZAN regulatory team’s judgment is that this status will produce spillover effects through three routes: first, accelerated implementation of UDI and semantic standards (Resolución 1405 de 2022 was confirmed by INVIMA on March 12, 2026 as past its transition period, with the semantic report now fully mandatory); second, convergence of the vigilance system toward the IMDRF approach (the 72-hour serious adverse event reporting and quarterly periodic reports of Resolución 4816 de 2008); third, the 2026 draft decree incorporates a reliance mechanism on the assessment outcomes of foreign regulators such as the FDA, EMA and ANVISA. For foreign manufacturers, the most tangible consequence is that compliance details once bypassed through local handling are now being closed off one by one.

2. Legal basis

3. Expert insights

#### Affiliate membership is an alignment commitment, not standard equivalence

IMDRF Affiliate status means INVIMA has committed to aligning its regulatory practice with IMDRF guidance; it does not automatically produce mutual recognition with the EU MDR or the US FDA. The GRZAN regulatory team stresses that Colombia has no automatic conversion mechanism based on CE or FDA certificates — Art. 16 and Art. 17 of Decreto 4725 de 2005 still require the complete technical and legal documentation. What actually changes is the frame of reference: the classification logic is homologous with the EU MDR (Art. 6, Art. 7), so companies with existing CE technical documentation face less friction when recalculating classification, and only once the draft’s reliance mechanism takes effect could the depth of review be substantively shortened.

#### Semantic standards and UDI are the first spillover results to materialize

Resolución 1405 de 2022 established the estándar semántico and UDI-DI coding requirements, dividing attributes into three groups: basic attributes (UDI-DI, GMDN codes and terms, registration number, issuing agency), regulatory attributes (manufacturer information, risk classification, special storage and packaging conditions) and commercial attributes (commercial description, commercial packaging units, minimum unit of use). The transition period is risk-tiered: registrations obtained on or after February 8, 2024 must be completed before commercialization; Class III devices and IVD Categoría III had 12 months, Class IIb and IVD Categoría II 18 months, and Class IIa, Class I and IVD Categoría I 24 months. On March 12, 2026, official INVIMA communication confirmed the transition period had ended and the semantic report is fully mandatory. Issuing agencies must be one of GS1, HIBCC, ICCBBA, IFA, Ali Health or ZIIOT. The GRZAN judgment is that UDI has moved from a bonus item to a precondition of commercialization — products without completed coding effectively lack the conditions for lawful circulation.

#### Internationalized vigilance expectations raise the cost of post-market violations

Resolución 4816 de 2008 already requires serious adverse events to be reported within 72 hours of awareness, periodic reports to be submitted quarterly, and recalls to be executed per INVIMA instructions. The pressure of IMDRF alignment will show up in enforcement intensity rather than in the text itself — completeness of reports, causal determinations and the rigor of trend analyses will all be examined more closely. The GRZAN regulatory team recommends treating vigilance as the first line of continuous compliance, not a table the regulatory department assembles at year-end.

4. Practical recommendations

1. The GRZAN regulatory team reviews existing Colombian technical documentation against the IMDRF approach, focusing on the consistency of GMDN terms, UDI-DI coding and risk classification.
2. Select one issuing agency among GS1, HIBCC, ICCBBA, IFA, Ali Health and ZIIOT, complete UDI-DI coding, and synchronize the basic, regulatory and commercial attribute groups in the semantic report.
3. For registrations obtained on or after February 8, 2024, complete the semantic report before commercialization; for existing products the risk-tiered transition periods have ended, the semantic report has been fully mandatory since March 12, 2026, and products with gaps may not be commercialized.
4. Have the titular establish a vigilance accountability system: report serious adverse events to INVIMA within 72 hours of awareness and submit periodic reports quarterly.
5. Companies with existing CE or FDA documentation should recalculate classification under Art. 6 and Art. 7 and retain the rule numbers, preparing for the future reliance mechanism.
6. Track the final wording of the reliance mechanism in the draft and assess its actual impact on the depth of review for Class IIb/III standard registration.
7. Do not claim in external communications that Colombia offers an automatic conversion route for CE/FDA certificates, to avoid misleading channels and end customers.

5. Verification checklist

• □ The timing and session of the IMDRF Affiliate status have been confirmed (2025-09-18/19, 28th session, Sapporo)
• □ UDI-DI coding has been completed, with the issuing agency among GS1, HIBCC, ICCBBA, IFA, Ali Health and ZIIOT
• □ GMDN codes and terms have been filed and are consistent with the product’s intended use
• □ The semantic report covers the basic, regulatory and commercial attribute groups (Resolución 1405 de 2022)
• □ It has been confirmed that the semantic report is fully mandatory from 2026-03-12, with no outstanding items
• □ A mechanism for 72-hour serious adverse event reporting and quarterly periodic reporting has been established (Resolución 4816 de 2008)
• □ Classification has been recalculated under Art. 6 and Art. 7 with rule numbers retained
• □ No external material contains claims of automatic CE/FDA certificate conversion

Regulatory information verified as of October 29, 2026

All outward-facing conclusions are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN provides end-to-end INVIMA registration and compliance support for manufacturers entering the Colombian market, covering UDI and semantic reporting, vigilance systems, classification recalculation and post-market compliance. For inquiries about INVIMA registration in Colombia, contact info@grzanglobal.com.