CE and FDA Evidence in Colombia INVIMA Registration

1. Key takeaways

Under Colombia’s current regulations there is no channel to exchange a CE certificate or an FDA clearance directly for an INVIMA registration certificate. CE and FDA documents can, and should, be submitted as components of the technical file to support the safety and effectiveness argument, but they produce no exemption effect, change no pathway, and shorten none of the 90 business days statutory review period. GRZAN must state this plainly: the claim circulating in the market that a CE mark means a fast certificate has no basis under current law.

The real institutional change is written in a draft that has not yet entered into force. The draft Proyecto de Decreto on the Régimen Sanitario de Dispositivos Médicos (about 16 chapters and 180 articles) plans to include a reliance mechanism on evaluation outcomes of foreign regulators such as the FDA, EMA and ANVISA; the draft was published in January 2026, went through WTO international notification on May 18, 2026, closed its comment period on July 17, 2026, and itself proposes an 18-month transition period; as of the verification date it has not been signed or promulgated. Meanwhile, INVIMA was approved as an affiliate member at the 28th IMDRF Management Committee meeting held in Sapporo on September 18–19, 2025 — the direction is clear, but current law remains Decreto 4725 de 2005, published on December 26, 2005, and its amending decrees.

2. Legal basis

3. Expert insights

#### Current law contains no reliance institution at all

Articles 18 and 19 of Decreto 4725 de 2005 are checklist requirements: every item on the list must be fulfilled by the applicant, and the text contains no provision treating a foreign regulator’s approval as a substitute for performance. This is the soft part of the landscape — reading reference-market approvals as an entry shortcut. GRZAN proactively corrects this expectation in commercial communication, because a project plan built on a wrong expectation will collapse midway.

#### The real value of reference-market documents sits at the evidence layer

The solid part matters just as much. CE certificates, FDA clearances and the technical documentation, clinical evaluations and risk management files behind them are ready-made sources of evidence for safety and effectiveness, and can directly support multiple arguments within the Art. 18 technical document list. GRZAN’s practice: reorganize reference-market documents under the Art. 18 items rather than attaching the whole package, and build a correspondence index between English originals and official Spanish translations. Only done this way do reference-market investments convert into actual effect within a Colombian filing.

#### Treating CE/FDA as an exemption drags classification and language down with it

The list of matters not exempted by reference-market approval is longer than expected: classification must still be determined independently under Art. 6 and Art. 7 (a CE class cannot substitute); documents must still be in Spanish or in English with official Spanish translation; the company must still designate a Colombian legal representative (apoderado / representante legal) with the power of attorney executed per Art. 29; and the importer must still hold a valid CCAA. GRZAN’s judgment: reference-market evidence saves argumentation effort, not localization work.

#### When reliance lands, the winners are the companies with complete dossiers

The reliance mechanism the draft plans to write in is essentially accepting another regulator’s review conclusion. The beneficiaries of such a mechanism are the companies that already hold complete, traceable technical documentation — without documents, reliance has nothing to rest on. INVIMA becoming an IMDRF affiliate member also lays groundwork for future alignment with internationally standard document formats such as the IMDRF table of contents structure. GRZAN’s recommendation is explicit: structure the technical dossier to the international standard now, so it plugs in directly when the mechanism lands. This is the only approach that benefits from both the old and the new rules across an institutional change.

4. Practical recommendations

1. At project initiation, the GRZAN regulatory team explains to the client in writing that no CE/FDA certificate-exchange channel exists under current law and that reference-market documents are used as evidence, producing no exemption.
2. The technical documentation lead reorganizes the CE/FDA technical files under the Art. 18 items instead of attaching whole packages, and builds a correspondence index between English originals and official Spanish translations.
3. The registration team completes the Colombian classification determination independently under Art. 6 and Art. 7, never substituting a CE class or FDA classification directly.
4. The titular designates a Colombian legal representative and executes the power of attorney per Art. 29, with all submitted documents rendered into Spanish.
5. The strategy function tracks the signature and promulgation milestones of the new draft decree, focusing on the final wording and applicability conditions of the reliance mechanism.
6. The documentation management team organizes technical documentation to the international standard structure, including IMDRF table-of-contents logic, to preserve integration capability once the reliance mechanism lands.

5. Verification checklist

• □ Project stakeholders have been clarified in writing that no CE/FDA certificate-exchange channel exists under current law
• □ CE/FDA technical files have been reorganized under the Art. 18 items, without whole-package attachments
• □ A correspondence index exists between English originals and official Spanish translations
• □ The Colombian classification determination has been completed independently under Art. 6 and Art. 7
• □ The local apoderado and power of attorney (Art. 29) are ready and documents have been rendered into Spanish
• □ The importer’s CCAA validity has been confirmed
• □ A tracking and comparison ledger exists for the draft decree’s reliance mechanism provisions
• □ Technical documentation has been organized to the international standard structure with integration capability in place

Regulatory information verified as of October 29, 2026

All external conclusions rest on the current regulatory texts published by the competent authority, verified provision by provision before delivery.

GRZAN converts CE and FDA documentation into effective evidence within INVIMA filings for the Colombian market, while keeping classification, language and representation obligations fully on local legal footing. For inquiries, contact info@grzanglobal.com.