Key Clauses in Colombian Device Distribution Agreements

1. Key takeaways

A distribution agreement in Colombia is not only a commercial contract; it is at the same time the governance document for a regulatory asset. GRZAN requires four clauses to be written in: registration ownership (the titular is the manufacturer or its designated entity), access to the technical file (corresponding to the technical documentation of Art. 18 and the legal documentation of Art. 19 of Decreto 4725 de 2005), safety liability (corresponding to the vigilance obligations of Resolución 4816 de 2008), and an exit mechanism (transfer of the certificate and disposal of stock).

What the four clauses share is that none of them governs how to sell; they only govern who bears the consequences when selling stops. The registration certificate is valid for 10 years, while the commercial cycle of a distribution agreement is usually shorter than 10 years; leaving these four matters unwritten means staking a ten-year asset on a short-term cooperation.

2. Legal basis

3. Expert insights

#### Registration ownership: writing it in the agreement is not enough; it must land on the certificate

An agreement clause saying the certificate belongs to the manufacturer is a claim at the level of obligations in contract, which does not necessarily prevail against the registry externally. What truly works is the name in the titular field of the certificate. GRZAN’s position: the agreement and the registration status must match; a clause without a corresponding registration merely sets up a future evidentiary dispute. Where a partner genuinely must hold the certificate, an irrevocable transfer commitment and power of attorney should be signed at the same time.

#### Access to the technical file decides who blocks whom at the moment of change

Art. 18 and Art. 19 list the technical and legal documentation respectively, and the originals of these documents are normally held by the manufacturer. Once the relationship deteriorates, the certificate holder without the file cannot answer deficiencies or renew the certificate – and the deficiency response period is a practical estimate of 90 days, with one unanswered notice treated as suspension. Conversely, if all materials sit with the channel partner, the manufacturer is locked in from the other side. GRZAN recommends making it explicit: the manufacturer retains the materials, and the channel party receives a usage license limited to what performing the registration and vigilance duties requires, not ownership.

#### Safety liability cannot be summarized as each party being responsible for itself

The deadlines of Resolución 4816 de 2008 are hard: serious adverse events must be reported to INVIMA within 72 hours of becoming known, periodic reports are submitted quarterly, and recalls are executed per INVIMA instructions. The 72-hour window spans language conversion and time zones, so the agreement must specify the information path, the deadlines and the responsible persons – who receives clinical feedback, who relays it to the local representative within how many hours, and who signs recall execution documents externally. Implantable devices additionally involve the patient implant card of Art. 40, making traceability duties heavier.

#### The exit mechanism must cover transfer cooperation and stock disposal

An exit clause should contain at least three things: the cooperation duty and deadline for transferring the certificate, who bears the transfer fee (change of legal nature, COP 826,546), and a transition period for selling stock on hand with continuity of recall liability. Missing any one of these turns the exit into a standoff.

4. Practical recommendations

1. Manufacturer legal counsel: state in the first clause that the titular is the manufacturer or a legal entity it establishes in Colombia, and the channel party obtains only sales rights.
2. GRZAN regulatory team: verify the registration ownership clause matches the certificate’s registration status and initiate a change where it does not.
3. Technical documentation lead: stipulate in the agreement who retains the Art. 18 technical file, the scope of the usage license, and the return/destruction conditions.
4. Vigilance lead: annex to the agreement the transmission path and responsible persons for 72-hour reports and quarterly periodic reports.
5. Commercial: in the exit clause, set the transfer cooperation deadline, the party bearing the transfer fee (COP 826,546) and the stock transition period.
6. Quality department: assign the traceability duty for the patient implant card (Art. 40) of implantable products to a specific entity within the agreement.

5. Verification checklist

• □ The agreement states the titular is the manufacturer or its designated entity
• □ The certificate’s registration status matches the agreement
• □ The holder of the technical file and the scope of the usage license are agreed
• □ Responsible persons for 72-hour vigilance reports and quarterly periodic reports are designated
• □ Recall execution and cost bearing are written into the agreement
• □ The exit clause includes a transfer cooperation deadline and the party bearing the COP 826,546 fee
• □ The stock transition period and vigilance liability during it are agreed
• □ The relationship between the agreement term and the certificate’s 10-year validity has been assessed

• 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 reviews and drafts distribution agreements for the Colombian market, aligning registration ownership, technical file access, vigilance liability and exit mechanisms with the certificate on file, and supports local licensed-entity and importer arrangements with fee budgeting. For a four-clause review before you sign, contact us at info@grzanglobal.com.