Colombia - Regulatory Roadmap & Technical Dossier Requirements for Medical Devices (Low Risk: Class I and IIa)
Medical Devices - Low Risk: Class I and lla
Regulatory Roadmap
Submission Method
Applications for registration can be submitted in person and/or online.
Type of Market Approval
Non-controlled Class I and lla devices are eligible for "automatic" registration. Controlled devices and Class Mb and III devices are subject to pre-market approval.
Roadmap by Class
Non-controlled Class I and lla
The registration process for automatic approval of non-controlled Class I and lla devices will require the following steps:
Appoint local representative through 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 15-30 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 90 business days of the request).
Make any legal and technical revisions of the application, if required by INVIMA.
Maintain post-market obligations.
Technical Documentation
Registration requirements are listed in Article 18 of Decree 4725/2005 for Non-Controlled devices. Controlled devices must additionally include items listed in Article 24. Registration procedures, requirements, and fees are offered on the INVIMA website. Additionally, a requirement checklist is included in the application form.
Dossier Requirements
Class I and lla Devices
The following documentation is required for registration submissions for Class I and lla devices:
A power of attorney in favor of the applicant for registration (if third-party is used for application), which must be Apostilled or legalized by the 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.
Duly completed form, signed by the technical director, including:
Generic name or mark of the medical device.
Commercial presentation.
Name of the manufacturer.
Registration route.
Expected useful-life/shelf-life, when applicable.
Classification.
Indications for use.
International codes (ECRI, GMDN, or other of equal recognition international).
Warnings, precautions, and contraindications.
Copy of the Quality Management System (QMS) certificate.
Description of the medical device: List of main parts, composition (when applicable), specifications, mode of operation, descriptive information.
Technical Studies and analytical tests: Summary reports on verification and validation (test report), design, or analysis certificate finished product containing the specifications, indicating the values or ranges acceptance. For biomedical devices, evidence should establish the design meets the applicable standards and specifications.
Method of sterilization, if applicable.
Method of disposal of the product, if applicable.
Final labels and inserts.
A declaration that Spanish language versions of the operating and maintenance manuals will be made available.
If necessary, additional information to evaluate the safety of the medical device, as requested by INVIMA.
For Class lla submissions, scientific information needed to support product safety, and risk analysis of the medical device according to manufacturer's specifications, list of specific standards applied, and description of solutions adopted to meet the essential safety and performance.
Certificate of free sale, apostilled or notarized/legalized by a Colombian consul at the country of origin.
Standards
Testing to international standards is generally accepted by INVIMA.
Clinical Data
According to article 18 (k) of Decree 4725/2005, information on the technical evaluation or clinical studies must be submitted with the registration application for Class lib and III devices.
Clinical testing data from other countries are generally accepted by INVIMA. Additionally, INVIMA clarifies the expected methodological design quality of submitted clinical data 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 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 is not required for registration in Colombia. However, per Article 21 of Decree 4725/2005, INVIMA may request samples during the registration process to perform technical analysis, if necessary.
Labeling
Requirements
Labeling requirements are addressed in Chapter VIII of Decree 4725/2005 and are similar to EU requirements.
Labels must contain at least the following information in Spanish.
Name of the product.
Lot number or series.
Expiration date (when appropriate).
Health registration number or marketing permit.
Manufacturer and/or importer and their addresses.
Special indications, such as "sterile" or "single-use only."
For imported devices, the labels will be accepted as in the country-of-origin in any language, with the addition of the Registration number and the name and domicile of the authorized representative or importer in Colombia. This additional information may be added as a sticker, usually done by the importer when the product arrives in Colombia.
Implantable medical devices are required to include an "implant card" containing the following information, per Article 40 of Decree 4725/2005:
Product name and model.
Lot or serial number.
Name and address of the manufacturer.
Name of the institution where the implant procedure was performed.
Identification of the patient.
E-Labeling
E-labeling is not permitted in Colombia.
Advertising
Regulations for advertising are addressed in Article 58 of Decree 4725/2005. Only registered devices may be advertised in Colombia. Class I devices may be advertised to the general public. Higher risk class devices intended for exclusive use by health professionals may only be advertised in scientific or technical publications.
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. The official registration fees are as follows:
• Non-controlled Class I and lla device: COP $2,511,952
• Non-controlled Class lib and III device: COP $2,843,199
• Controlled device: COP $2,870,803
Time-to-Market
Non-controlled Class I and lla
For device classes I and lla, registration is "automatic," meaning that it will be obtained 15-30 days after a complete submission is made. INVIMA reserves the right to review the submitted information after automatic registration is granted; if INVIMA considers more information is to be submitted it will be requested, and the registrant will have 90 days to comply. Failure to do so will result in the suspension of the registration for 3 months, after which time it is canceled, per Article 22 Decree 4725/2005.