Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
INVIMA
Register your medical device in Colombia.
Access the Colombian market through Health Notification (Class I and IIa) or Health Registration (Class IIb and III), with a local Registration Holder.
Speak to a specialistThe authority
Instituto Nacional de Vigilância de Medicamentos y Alimentos
INVIMA
Regulatory authority
Colombia
A national institute attached to the Ministry of Health and Social Protection, responsible for sanitary surveillance of medicines, food and medical devices in Colombia.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, Health Notification | Bandages, masks, gauze |
| Class IIa | Low-to-moderate risk, Health Notification | Simple diagnostic equipment |
| Class IIb | Moderate-to-high risk, Health Registration | Infusion pumps, surgical equipment |
| Class III | High risk, full Health Registration | Implants, pacemakers, haemodialysis equipment |
Registration process
How we manage your project
- 01
Registration Holder (Titular del Registro)2-3 months
Establish a Colombian company as the Registration Holder
- 02
Classification2 weeks
Determine the class under Decreto 4725/2005
- 03
QMS3-6 months
ISO 13485 and Latin American GMP
- 04
Technical dossier2-4 months
Prepare the submission in Spanish
- 05
INVIMA submissionvariable
Class I and IIa: immediate acceptance. Class IIb and III: 6-8 months for assessment
- 06
Registration issuance1-2 weeks
Certificate and registration number issued
Total timeframeClass I and IIa: 1 month. Class IIb and III: 6-8 months
Local representativeRegistration Holder (Colombian company)
Approximate costClass III: USD 2k-3.7k in fees plus consultancy
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | INVIMA technovigilance and adverse event reporting |
| Renewal | 5 years, renewable |
| Required QMS | ISO 13485 and Latin American GMP |
How HSC helps
Colombia in 1 month for Class I/IIa or 6-8 months for IIb/III.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about INVIMA
Next step
Ready to start your project in Colombia?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist