Appointing the Apoderado and Legal Representative in Colombia

1. Key takeaways

A foreign manufacturer cannot file directly with INVIMA; it must appoint a local legal representative in Colombia (apoderado / representante legal). This is a mandatory requirement established by Decreto 4725 de 2005, implemented through the legal documentation list in Art. 19 and the power of attorney (POA) in Art. 29. Without a local apoderado, there is no valid filing entity in SIRIS, and no matter how complete the technical dossier is, the file cannot enter substantive review.

GRZAN’s assessment is that the value of an apoderado lies not in signing but in the speed of response within the deficiency-correction window. Automatic registration is reviewed in 2 business days and standard registration in 90 business days; the response period for deficiency notices is a practical estimate of 90 days, and a single unanswered notice is treated as suspension. The gates of all these timelines are held by the local representative who can actually receive INVIMA notifications and organize the answers. Given that the INVIMA registration database holds about 423,000 records and Chinese manufacturers account for roughly 14.4% of them (third-party statistics), appointing a local representative is already routine for Chinese companies – it should not wait until a deficiency notice arrives and a provider has to be found in a hurry.

2. Legal basis

3. Expert insights

#### The mandate comes from the legal documentation list, not from formatting

Art. 19 places the POA on the legal documentation list, which means it is not a formal attachment but an admissibility requirement; Art. 29 further prescribes how the power of attorney must be executed. Read together, these two provisions show that INVIMA only engages with the local representative of record. All submission documents must be in Spanish, and technical or scientific information may be provided in English with an official Spanish translation – the language barrier likewise falls on the local representative.

#### Responsibility boundaries belong in the POA, not in later arguments

A POA can be broad or narrow. GRZAN recommends enumerating the authorized acts precisely: submitting applications, receiving notifications, answering deficiencies, collecting the registration certificate, and signing changes and renewals. Anything involving disposal of the certificate (transfer, waiver, change of registered entity) or substantive modification of technical content should require separate confirmation issued by the titular alone. Otherwise, one unauthorized signature can cost the manufacturer a change-of-legal-nature fee of COP 826,546 to fix.

#### Vigilance obligations are also anchored to the local representative

Resolución 4816 de 2008 requires serious adverse events to be reported to INVIMA within 72 hours of becoming known, periodic reports to be submitted quarterly, and recalls to be executed per INVIMA instructions. When a foreign manufacturer receives hospital feedback in its home country, without a local representative to relay and file the report, the language conversion and time zones alone make the 72-hour window practically impossible to meet. This is why the apoderado and the vigilance responsible person are frequently appointed together.

4. Practical recommendations

1. Manufacturer legal counsel: execute the POA in the manufacturer’s country of registration, through the notarization and authentication chain, with an official Spanish translation attached.
2. GRZAN regulatory team: check the list of authorized acts in the POA item by item, excluding any disposal of the certificate or substantive technical changes.
3. Quality and vigilance lead: name the vigilance reporting responsible person in the POA or a separate appointment letter, ensuring the 72-hour reporting chain can actually run.
4. Registration specialist: agree with the local representative on a notification relay deadline – forward INVIMA notices to the manufacturer within 24 hours of receipt (practical estimate).
5. Project manager: reverse-schedule the deficiency response period of 90 days (practical estimate) into internal milestones, with day 60 as the internal red line.
6. Compliance lead: when the apoderado changes, update the POA and the contact information in SIRIS at the same time to avoid failure of notification delivery.

5. Verification checklist

• □ A local apoderado / representante legal in Colombia has been appointed
• □ The POA has been notarized, authenticated and officially translated into Spanish
• □ The authorized acts in the POA are enumerated item by item and do not include transfer or waiver of the certificate
• □ The authorized acts cover submission, deficiency responses, certificate collection, changes and renewals
• □ The vigilance responsible person has been designated and can report within 72 hours
• □ A relay deadline and responsible person for INVIMA notifications have been agreed
• □ The internal countdown for deficiency responses is set at 90 days (practical estimate)
• □ The timelines of 2 business days for automatic registration and 90 business days for standard registration are built into the project plan

• GRZAN regulatory team

Regulatory information verified as of October 29, 2026

All conclusions published here are based on the current regulatory texts issued by the competent authority and are verified item by item before delivery.

GRZAN supports manufacturers entering Colombia with the appointment of local licensed entities and importers, drafting and authentication of apoderado powers of attorney, and fee budgeting for registration and vigilance compliance. If you need a dependable local representative structure that protects your certificate and your timelines, our regulatory team can design it end to end. Contact us at info@grzanglobal.com.