Changing the Titular or Representative in Colombia

1. Key takeaways

Changing the certificate holder, changing the legal representative, or cancelling and reapplying – all three routes work in Colombia, but their costs differ sharply. Changing the titular is a change of legal nature with an official fee of COP 826,546; changing the apoderado only requires reissuing the power of attorney under Art. 29 and updating the contact information in SIRIS, with no change fee; cancelling and reapplying means paying the registration fee again – 321.91 UVB ≈ COP 3,898,330 for class I/IIa, 364.36 UVB ≈ COP 4,413,000 for class IIb/III – and waiting for review all over again.

GRZAN’s assessment is that if a representative can be changed, do not change the holder; if a change can be filed, do not cancel. The cost of changing the representative concentrates in documents; the cost of changing the holder concentrates in review; the cost of cancelling and starting over falls on time and market absence – automatic registration takes 2 business days and standard registration 90 business days, excluding the round trips of deficiency responses and the rework of the dossier.

2. Legal basis

3. Expert insights

#### Changing the representative is the lightest action; changing the holder is the heaviest

The apoderado is the agent of the titular, so changing the agent does not touch the registered entity; in essence it is a document update. Changing the titular alters the right-holder that the administrative act points to; it is a change of legal nature with an official fee of COP 826,546 and requires legal documents issued by both parties. When structuring engagements for clients, GRZAN places the variable elements at the representative level and fixes the registered entity.

#### Cancellation is not a free exit: the certificate is gone, the market is still there

Cancellation terminates the effect of the registration certificate, but products already placed on the market remain subject to vigilance duties; the 72-hour serious adverse event reporting and quarterly periodic reports of Resolución 4816 de 2008 are not automatically waived by cancellation. If no successor entity and stock disposal plan are arranged before cancellation, the market carries a long period of certified-goods-without-certificate status, a high-risk scenario in verification.

#### The real cost of reapplying is time and channels, not just the fee

Reapplying requires paying COP 3,898,330 or COP 4,413,000 again, but what is more expensive is the gap: distribution channels interrupted, tender qualifications lost, and completed market access work rendered void. In a market that depends on imports for roughly 80%–85% of its supply, the out-of-stock period is usually filled by competitors. GRZAN’s advice is to treat the renewal window as a hard calendar item – at least 3 months before device expiry and within 6 months before IVD expiry.

#### The regime is being rewritten, so entity structures should keep flexibility

The MSPS draft decree Régimen Sanitario de Dispositivos Médicos was published for comment in January 2026 (about 16 chapters and 180 articles), notified to the WTO on May 18, 2026 with comments closing July 17, 2026; directions include a three-tier authorization system, validity changed to indefinite and linked to post-market performance, and a self-proposed 18-month transition period. As of the verification date it has not been signed or promulgated, and Decreto 4725/2005 and Decreto 3770/2004 remain in force. GRZAN’s judgment: do not write current entity arrangements so rigidly that they cannot migrate; leave a transferable path.

4. Practical recommendations

1. Manufacturer legal counsel: prefer changing the apoderado, reissuing the power of attorney under Art. 29 with the Spanish translation completed.
2. GRZAN regulatory team: where the titular genuinely must change, obtain the corporate documents of both parties first, then file the change of legal nature with a budget of COP 826,546.
3. Registration specialist: after any change, immediately verify that the titular field on the certificate and the SIRIS contact information have both been updated.
4. Project management: set renewal windows as hard calendar items – 3 months before device expiry and within 6 months before IVD expiry.
5. Vigilance lead: before cancellation, secure a successor for the vigilance duties on stock and in-use products and keep the 72-hour reporting chain alive.
6. Corporate planning lead: track the progress of the Proyecto de Decreto and assess the impact of the 18-month transition period on existing entity arrangements.

5. Verification checklist

• □ The change type is confirmed: representative change, entity change, or cancel and reapply
• □ The new POA for a representative change has been issued under Art. 29 with the Spanish translation completed
• □ The entity change budget includes the change of legal nature at COP 826,546
• □ The reapplication budget includes COP 3,898,330 (I/IIa) or COP 4,413,000 (IIb/III)
• □ After the change, the titular field on the certificate and the SIRIS information are synchronized
• □ Renewal windows are scheduled: devices 3 months, IVDs within 6 months
• □ The vigilance successor and stock disposal plan are in place before cancellation
• □ The signing status and transition arrangements of the Proyecto de Decreto are being tracked

• 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 manages holder and representative changes for manufacturers in the Colombian market, from POA reissuance to changes of legal nature and renewal scheduling, and provides local licensed-entity and importer support with complete fee budgeting. To plan a change without losing your certificate or your market window, contact us at info@grzanglobal.com.