Colombia - Regulatory Roadmap & Technical Dossier Requirements for Medical Devices (High Risk: Class IIb, III, and Controlled)

Colombia-Regulatory Roadmap & Technical Dossier Requirements for Medical Devices

Medical Devices - High Risk: Class IIb, llI, and Controlled

Regulatory Roadmap

INVIMA Colombia registration process for medical devices.

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, Class IIb, and III devices are subject to pre-market approval.

Roadmap by Class

Controlled, Class lIb, and III Devices

The device registration process for pre-market approval of Controlled devices and Class lIb and III devices will require the following steps:

INVIMA Colombia registration costs for medical devices and in vivo diagnostic (IVD) products.

  1. Appoint local representative through power of attorney.

  2. Ensure documents provided by the manufacturer are compliant with INVIMA requirements.

  3. Compile the technical submission in Spanish (or at least Spanish summaries of test reports).

  4. Provide product certifications and manufacturer's testing methodology.

  5. File the application with INVIMA.

  6. Answer any questions that INVIMA may ask regarding the registration (responses must be submitted within 90 business days of the request).

  7. Upon approval, begin marketing.

  8. Make any legal and technical revisions of the application, if required by INVIMA.

  9. 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 lib and III Devices

The following documentation is required for registration submissions for Class IIb or III Non-Controlled devices:

  1. A power of attorney in favor of the applicant for registration (if third-party is used for application), which must be apostilled or notarized/legalized by a Colombian consul in the country of origin.

  2. Letter of authorization to the importer(s), on company letterhead, signed by a person responsible for the manufacturing of the product within the company.

  3. Duly completed application form, including:

    1. Generic name or brand of the medical device.

    2. Commercial presentation.

    3. Name of the manufacturing industry.

    4. Mode of registration.

    5. Shelf-life, if applicable.

    6. Classification according to risk.

    7. Indications and uses.

    8. International code (ECRI, GMDN of equal or international recognition).

    9. Warnings, precautions, and contraindications.

  4. Copy of Quality Management System (QMS) certificate.

  5. Description of the medical device: List of main parts and its composition when applicable, specifications, performance, descriptive information in the Spanish language.

  6. 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.

  7. Method of sterilization, if applicable.

  8. Method of disposal, if applicable.

  9. Sample labels and inserts.

  10. (For biomedical equipment) Statement committing to provide maintenance manuals in Spanish.

  11. If necessary, additional information to evaluate the safety of a medical device, as requested by INVIMA.

  12. Scientific information needed to support product safety and risk analysis of the medical device according to the manufacturer's specifications, list of specific standards applied, and description of solutions adopted to meet the essential safety and performance.

  13. Clinical studies to demonstrate safety and effectiveness.

  14. 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 Colombian consul at the country of origin.

Controlled Devices

Applications for Controlled devices must additionally include the following:

  1. Certificate or proof of compliance with international quality standards, issued by national or international experience and recognition (ISO 13485 Certificates for the manufacturer, and for all contract manufacturers).

  2. Name and location of the lending institution of Health Services, IPS, in which to install the equipment, or commitment to report on it, if it has not yet been commercialized.

  3. A statement issued by the manufacturer or the representative in Colombia regarding the equipment, which shall include the following:

    1. The equipment has been tested.

    2. That the manufacturer is able to provide supplies, parts, spare parts and maintenance services for 5 years or more, or throughout the shelf-life of the equipment.

    3. That the manufacturer will provide the user with the programs and facilities for the training of the operators and maintenance engineers or technicians, if applicable.

    4. That the manufacturer will deliver to the final user the manual in the Spanish language, and that operating, and maintenance manuals will be available if necessary.

All technical information must be on the company's letterhead and signed by a responsible person within the company.

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:

  1. Performed on human beings to demonstrate safety and effectiveness.

  2. 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).

  3. 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 with the address.

  • 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 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.

Advertisement

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 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 $2,662,692.

  • Non-controlled Class lib and III device: COP $3,013,777.

  • Controlled device: COP $3,042,975.

Time-to-Market

Controlled, Class lIb, and III

The official review time for Controlled devices and Class lib and III devices is 90 business days; however, actual review times may extend to around 6-8 months, depending on the complexity of the product. If INVIMA requests additional information, the registrant will have 90 days to comply.

Regulatory consulting, Regulatory, Market Access, INVIMAJulio G. Martinez-Clarkregulatory roadmap, technical dossier, document requirements, medical devicesComment