Registration Type and Authorized Scope in Colombia

1. Key takeaways

The TIPO DE REGISTRO field on a Colombian registration certificate states the type of authorization and the authorized acts, not the risk class. Decreto 4725 de 2005 sets out three channels: the Registro Sanitario under Art. 16 (class IIb/III devices), the Registro Sanitario Automático under Art. 17 (class I/IIa devices), and the Permiso de Comercialización under Art. 23 and Art. 24 (controlled-technology biomedical equipment). Whichever authorization you obtain, you may only act within its corresponding scope.

GRZAN’s assessment is that the trap Chinese manufacturers most easily fall into is conflating importar y vender with local repackaging, labeling or assembly. Differences of this kind are not caught at the issuing stage, because the review looks at documents; they are flagged directly in post-grant verification – Article 57 of Ley 962 de 2005 requires INVIMA to carry out follow-up control within 15 days after issuance. Correcting the scope then means going through the change channel: COP 826,546 for a change of legal nature, COP 1,060,243 for a change of technical nature, plus the risk of suspended sales in the meantime.

A practical discipline is to read the issued certificate as a contract clause by clause: the entity, the act, the model list and the validity must each be checked against the application as filed. Any deviation found at this stage is a request for correction; the same deviation found a year later is a formal change with a fee attached.

2. Legal basis

3. Expert insights

#### The authorization type defines the acts, not the class

For the same product from the same company, entering through the class IIa automatic route and the class IIb standard route yields different scopes of authorized acts; controlled-technology biomedical equipment does not even receive a registration certificate but a Permiso de Comercialización. GRZAN requires clients at project initiation to define the acts first and only then the channel: for import and sale, use importar y vender; for any production inside Colombia, the corresponding qualifications of a manufacturing entity must be obtained separately – one import certificate cannot cover it.

#### Post-grant verification is the real test of the authorized acts

Automatic registration operates on a certificate-first, verify-later basis – class I/IIa review takes 2 business days and standard registration 90 business days, so certificates are issued far faster than on-site inspections can follow. Article 57 of Ley 962 de 2005 compresses the follow-up control to within 15 days after issuance, which makes obtaining the certificate and being verified nearly the same event. GRZAN’s view: every extra act written on the certificate is one more point to be verified; better to write the scope narrow at application than broad for appearance.

#### The special import channel cannot replace regular registration

The vital no disponibles mechanism of Art. 48 targets important devices with no domestic alternative; it is an ad hoc special import authorization, not a ticket to long-term commercialization. Used as a routine path, it will force you back to the standard registration channel at the second import, and none of the earlier time investment carries over.

4. Practical recommendations

1. Manufacturer commercial team: at project initiation, define the list of acts in Colombia – import and sale only, or also repackaging, labeling or assembly.
2. GRZAN regulatory team: derive the channel from the act list, determining whether Art. 16, Art. 17 or Art. 23/Art. 24 applies.
3. Registration specialist: on receipt of the certificate, check the authorized acts field immediately against the initiation list item by item and request correction on the spot for any mismatch.
4. Importer: keep the act descriptions on the customs documents consistent with the authorized acts on the certificate to avoid documentary conflicts.
5. Compliance lead: prepare a response package for the post-grant follow-up control due within 15 days of issuance.
6. Project management: reserve a change budget of COP 826,546 or COP 1,060,243 in case the authorized scope needs correction.

5. Verification checklist

• □ The list of acts in Colombia was defined at project initiation
• □ The channel chosen (Art. 16 / Art. 17 / Art. 23–Art. 24) matches the act list
• □ The authorized acts field on the certificate matches the initiation list item by item
• □ Acts not written on the certificate (repackaging, labeling, assembly) have separate qualification planning
• □ Customs document descriptions match the authorized acts on the certificate
• □ Response materials for the follow-up control within 15 days of issuance are ready
• □ The change budget is reserved at both levels of COP 826,546 and COP 1,060,243
• □ The Art. 48 special import mechanism is not being used as a long-term commercialization path

• 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 advises manufacturers on choosing the right INVIMA authorization channel for the Colombian market, defining authorized acts before filing, and budgeting registration and change fees under the 2026 fee schedule, together with local licensed-entity and importer support. For a scope review before you file, contact us at info@grzanglobal.com.