Colombia Regulatory Roadmap & Technical Dossier Requirements for In Vitro Diagnostic (IVD) Devices (Category I & II)
In Vitro Diagnostic Devices (Category I and Il)
Regulatory Roadmap
Submission Method
Applications for registration can be submitted online.
Type of Market Approval
Category I and Il IVDs are eligible for automatic registration. Category Ill IVDs are subject to pre-market approval.
Roadmap by Category
Category I and Il
The registration process for automatic approval of category I and Il IVDs will require the following steps:
Appoint local representative through a power of attorney.
Ensure documents provided by the manufacturer are compliant with INVIMA requirements.
Compile the technical submission in Spanish (or at least Spanish summaries of test reports).
Provide product certifications and manufacturer's testing methodology.
File the application with INVIMA.
Receive automatic approval upon complete submission (within 2-4 days).
Begin marketing.
INVIMA will conduct a post-submission review. Answer any questions that INVIMA may ask regarding the registration (responses must be submitted within 30 working days of the request).
Make any legal and technical revisions of the application, if required by INVIMA.
Maintain post-market obligations.
Technical Documentation
Dossier Requirements
Category I, II, and III
The following documentation is required for registration submissions for all IVDs:
A power of attorney in favor of the applicant for registration (if third-party is used for application), which must be Apostilled or legalized up to a Colombian consul in the country of origin.
Letter of authorization to the importer(s), on company letterhead, signed by a person responsible for the manufacturing of the product within the company.
Duly completed application form, including,
Name of the product.
Name of the manufacturer and importer.
Application and use of the device.
Components.
Kit content.
Additional needed materials.
Trademark certificate issued by the Trademark Office.
Authorization of use of the trademark if the same is already registered.
Certificate of free sale (CFS) from the country of origin, or acceptable reference countries (EU, US, Canada, Japan, and Australia, or countries where there is mutual recognition agreement in force with Colombia).
Apostilled or legalized by a Colombian consul from the country of origin.
Certificates of Analysis (sensitivity, specificity, reproducibility).
Stability studies.
Insert.
Labels.
Quality Management System (QMS) CertificateStandardsTesting to international standards is generally accepted by INVIMA.
Clinical Data
INVIMA generally accepts clinical performance data from other countries. INVIMA clarifies the expected methodological design quality of the clinical studies to be submitted with the IVD technical dossier in Act No. 10, from 13 November 2019. This document states that clinical studies should be:
Performed on human beings to demonstrate safety and effectiveness.
Published in a magazine or scientific journal (periodical research publication that is of high quality, listed in a database of the global consultation, and that requires specialized methodological and technical evaluation for publication).
Submitted clinical data can be of similar or equivalent technologies to the one presented in the application of health registrations and can be up to 10 years from the issuance date.
Testing (local)
Local testing for category I and Il IVDs is not required. For category Ill IVDs without a valid CFS from a recognized reference country, the Specialized Board may require samples for local testing.
Labeling
Requirements
Labeling of IVDs is addressed in Article 25 of Decree 3770/2004. The labeling of the primary container of the IVD should contain:
Product name.
Name of the manufacturer and importer.
Lot number.
Expiration date.
Composition.
Intended use.
Conditions for storage.
Precautions.
Registration number.
Requirements for the Insert to be included with IVDs are listed in Article 10.1.1 of Decree 3770/2004. The Insert must provide a clear indication of the proper use and storage of the IVD. Imported IVDs can be labeled in the language of the country of origin; however, the Insert must be provided in Spanish. E-labeling is not permitted in Colombia.
Advertising
Regulations for advertising of IVD reagents are addressed in Articles 29 and 30 of Decree 3770/2004. Only registered IVDs can be advertised in Colombia, and the advertisement cannot make any claims beyond what is included in the registration.
Quality Management System
Manufacturers are required to have valid QMS certification. Foreign manufacturers must submit a valid QMS certificate issued by a recognized national or international entity as part of the registration application. INVIMA does not require certification to any particular QMS standards, but, in practice, most manufacturers provide their ISO 13485 certificate, which is INVIMA's general expectation.
Cost
Registration fees are listed on the INVIMA website.
Category I and Il
The fee to register category I and Il IVDs depend on the number of IVDs included within the same registration, with a maximum of 15 IVDs per registration. These registration fees range from COP $1,755,782 to COP $10,092,093.
Time-to-Market
Category I and Il
Category I and Il registrations are obtained within 2-4 days after submission, as long as the application is complete. If INVIMA requests additional information, the applicant has 30 working days to comply.