Requirements · Medical devices · Colombia
Health permit requirements for medical devices and biomedical equipment in Colombia
The legal and technical documents to obtain or renew the health permit for a medical device or biomedical equipment in Colombia, in class I, IIa, IIb or III. Tick what you already have, see what is missing, and copy or print the list.
The essentials
Key findings
- 016 documentsfor the legal file, from the power of attorney on behalf of SPI to local requirements for importers.See it
- 026 documentsfor the technical file, from the technical data sheet to the commercial history.See it
- 034 classesof risk share the same general list: I, IIa, IIb and III.See it
- 046 typesof support studies: biocompatibility, electrical safety, shelf life, claims, clinical and risk analysis.See it
- 05GMP or ISOfor the manufacturer's quality certificate, as applicable.See it
- 061 reportof health alerts goes with the commercial history.See it
- 07Reclassificationis possible: authorities may reclassify a product regardless of its original classification.See it
- 08In your namethe registration can stay, even if your company is foreign.See it
Chapter 1 of 4
Legal requirements
These documents show that the product is legally sold in its country of origin, that the manufacturer meets a quality standard, and who acts for you in Colombia. The same list applies to a new registration and to a renewal.
Legal documents
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Chapter 2 of 4
Technical information
The technical information describes the device, the studies behind its safety and performance, how it is used and how it has performed on the market.
Technical documents
0 / 6 ready
These are general requirements. As we advance in the process, we will share the detailed list for your product type and classification.
Chapter 3 of 4
Key considerations for regulatory compliance
Risk classes covered
- Class I
- Class IIa
- Class IIb
- Class III
- Risk classification: authorities may reclassify products regardless of their original classification.
- Legal paperwork: must be legalized or apostilled and officially translated.
- Technical documents: require translation into the local language (summaries are sometimes sufficient).
- Registration holder: in Colombia, foreign companies may be the holder of the registrations.
Chapter 4 of 4
How the process works with SPI
- 01 · DiagnoseFree initial assessmentWe review your product and tell you which filing applies, how long it takes and what it costs.
- 02 · RegisterDossier and filing before INVIMAWe build the dossier from your documents and file it before INVIMA.
- 03 · ProtectTrademark registration before the SICWe register your trademark before the Superintendence of Industry and Commerce.
- 04 · Operate & growLocal representation and distributorsWe represent you in Colombia and help you find distributors.
Let's talk
Registering a medical device in Colombia?
Tell us which device you want to register or renew and we will tell you which documents apply, how long it takes and what it costs.