Consulting services and advising in commercialization of medical devices in Colombia
To commercialize your medical equipment and devices in Colombia, you required a registry of the product before INVIMA (The National Food and drug Surveillance Institute), which is in charged of regulating sales of medical equipment and devices. INCAVEH has the experienced needed to provide assistance during these processes, we will never ask unnecessary documents to proceed.
Classification of medical equipment and devices in Colombia
The Colombian classification scheme for medical devices and equipment is similar to the one employed for the European Unión GHTF (GLOBAL HARMONIZATION TASK FORCE) it is composed by four level of classification Class I, Class IIa, Class IIb and Class III.
INCAVEH has the sufficient experience to help you out with the classification of your devices and the whole formality.
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BY THE MANUFACTURER |
BY THE IMPORTER |
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The manufacturer can modify the references or make changes when requiered |
The importer will add the references that it wants, therefore the manufacturer will depend for the addition of the references and modifications made by the importer. |
| If the manufacturer ends relations with the importer for several reasons (Low sales, low interest in the products, Company closures), the manufacturer will be able to change its distributor. | If the manufacturer ends commercial relations with the importer, the manufacturer should start all over again the registry process with a new importer. |
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The manufacturer includes in its sanitary registry the number of importers wanted in Colombia. |
When the sanitary registry is issued by the importer, it will be the only one autorized to sell the products. |
- Find one or several importers that count on a CCAA, mandatory document in Colombia (Certificado de capacidad de almacenamiento y acondicionamiento) as well as a Chamber of Commerce certification.
- Issue a Free Sale Certificate that includes all references the manufacturer wants to include.
- Documents of compliance of quality and clinical studies of the references.
- Send us all paperwork and we will proceed to get your registration.
OUR ADVICE
Incaveh group with more than five years of experience recommends the companies that want to enter in the Colombian market to issue their own sanitary registry with the objective of administer the representation of its products in Colombia.
INVIMA Documentation for Medical Equipment Registration
Colombia Medical Device Regulations
| Document | Number | Published | |
|---|---|---|---|
| Decreto 3275, 2009 |  |
3275 | 08/2009 |
| Decreto 4725, 2005 | |
4725 | 12/2005 |
| Resolution 004816, 2008 | |
004816 | 12/2008 |
Specific Guidance Documents
| Document | Number | Published | |
|---|---|---|---|
| Additional products regulated as medical devices | |
Acta 09/2014 | 09/17/2014 |
Additional Information
| Document | Number | Published | |
|---|---|---|---|
| Deadline to obtain health registration for various products | |
500-8060-13 | 12/2013 |
AREAS OF EXPERTISE
- Device Registration
- In-Country Representation
- Regulatory Consulting
- Distributor Qualification
