INVIMA-COLOMBIA DOCUMENT REQUIREMENTS FOR INVESTIGATIONAL MEDICAL DEVICE CLINICAL TRIALS

This is what you need to get your first-in-human medical device study approved at INVIMA in Colombia

We will assist you in submitting your medical device study protocol approval application. Learn about the requirements for an investigational drug clinical trial. Our product development team can also assist you in designing your human study and in creating the necessary documents for submission to Colombia's INVIMA (an agency part of the Ministry of Health).

Our US and Colombia-based team will assist you in gathering the necessary documentation, translating it to local Colombian Spanish —by an official translator certified by Colombia's Ministry of Foreign Affairs—, completing and submitting the application to INVIMA (National Institute of Food and Medicine Surveillance or Instituto Nacional de Vigilancia de Medicamentos y Alimentos in Spanish). 

All research on human beings in Colombia shall be evaluated and approved by the institutional review board (IRB or institutional ethics committee) affiliated at the site where the trial will be conducted. The IRB must evaluate the protocol, the informed consent form, all information known on the medical investigational product (including reports of unexpected adverse events) and all potential advertising planned to obtain participants; among other documents. Each IRB has its own scheduling and processing times.

The IRB’s approval will be delivered in writing and the information included in that document depends on each committee’s procedures. Once the approval letter is obtained, it must be included in the application submitted to INVIMA. If the IRB rejects the application, the clinical trial cannot be conducted, and the application cannot be submitted to INVIMA.

The INVIMA approval will authorize the sponsor's local legal representative in Colombia to the following: 

  1. The conduct of the clinical trial

  2. The centers and investigators

  3. The importation of the investigational medical device

  4. Any other commercial devices and supplies required for the study

 

Get your research site activated and your medical device first-in-human clinical trial quickly approved at the IRB/EC and the Ministry of Health (INVIMA) in Colombia. Start collecting your clinical data in Colombia now.

 

Colombia's INVIMA detailed document requirements for medical device clinical trial approval

Ethical Considerations/Documents

  1. Approval letter from the local institutional review board (IRB)/ethics committee (EC) for each of the participating research institutions (see Appendix section). The letter must specifically indicate approval of the following documents (including the document date and version number),

    • Protocol

    • Investigator's brochure

    • Informed consent form

    • Patient material for advertisement (before recruitment) and educational (post and after recruitment) purposes

  2. Patient’s informed consent form (ICF). It must follow guidelines per Article 15 and 16, Ministry of Health’s Resolution No. 8430 of 1993. This resolution establishes that informed consent obligations include providing clinical trial subjects with information on:

    1. The investigation objectives.

    2. The procedures that will be used.

    3. Any inconveniences and expected risks.

    4. The benefits that may be obtained.

    5. Any alternative procedures that could be advantageous for the research subject.

    Notes:

    • The ICF must use the word “daño” —instead of “lesión"— in Spanish as defined in Colombia's Civil Code, Art. 2341.

    • The ICF must include a) the insurance policy number, and b) the name of the insurance company that issued the policy.

    • Clinical trial subjects must:

    • Receive answers to any questions and doubts.

    • Be free to withdraw consent and to stop participating in the study.

    • Have patient confidentiality.

    • Be provided with updated information obtained during the study.

    • Be given medical treatment if any injuries arise as a result of the investigation.

    • Be reimbursed for any additional expenses, which should be covered by the budget of the investigation.

Cover Letter

  1. Protocol code number

  2. Protocol version and date

  3. Investigator's manual version and date

  4. Protocol title

  5. Phase of the study (e.g., pilot/I, II, III)

  6. Regions where the study is being conducted (e.g., Europe, Americas)

  7. Countries where the study is being conducted

  8. Name of the investigational medical device

  9. Control medical device (if applicable)

  10. Therapeutic area of the study

  11. Sample size (projected)

  12. Sample size (current, worldwide)

  13. List of countries (including Colombia) where the study is (or will be) conducted

  14. Total number of patients that will participate in the study (globally)

  15. Total number of subject that the sponsor plans to enroll in Colombia

  16. Number of subjects that the sponsor plans to enroll in each clinical research site in Colombia

  17. Duration of the study

  18. Study start date (estimated, worldwide)

  19. Study start date (estimated, Colombia)

  20. Study end date (estimated)

  21. Duration of the subject participation in the study

  22. Insurance policy (number, issue and expiration date)

  23. Participating clinical research sites or institutions including,

    • Physical address

    • Telephone

    • Name of investigator (principal and co-investigator)

Study Protocol

  • Hypothesis (as applicable)

  • Objectives

    1. General

    2. Specific

  • Methodology

    1. Type of study (clinical trial or observational trial)

    2. Demographics

    3. Sampling

    4. Inclusion and exclusion criteria

    5. Table of variables

    6. Information processing and analysis technique

      1. Information sources

      2. Information collecting instrument (i.e., case report form [CRF])

      3. Information collecting process (what, who, how, when)

    7. Procedure description

    8. Risk analysis, benefits, and risk mitigation

    9. Identification, analysis, and reporting of adverse events (According to the Ministry of Social Protection’s Resolution No. 4816 of 2008)

    10. Pilot trial

    11. Prevention of errors and study bias

    12. Technique for information processing and analysis

  • Bibliographic references (Vancouver System/ICMJE)

  • Study summary

  • Problem formulation

    1. Problem justification

    2. Proposal justification

    3. Research questions

  • Theoretical and conceptual framework

    • The intent of this framework is to facilitate communication between researchers and stakeholders in conceptualizing the research problem and the design of a study (or a program of research involving a series of studies) in order to maximize the potential that new knowledge will be created from the research with results that can inform decision making. To do this, research results must be relevant, applicable, unbiased and sufficient to meet the evidentiary threshold for decision making or action by stakeholders. In order for the results to be valid and credible, all persons involved must be committed to protecting the integrity of the research from bias and conflicts of interest. Most importantly, the study must be designed to protect the rights, welfare, and well-being of subjects involved in the research.

  • Information about the investigational medical device

    1. Name, brand, reference number

    2. Description

    3. Use and indications

    4. Label artwork with the following text: “Dispositivo Médico de Uso en la Investigación [STUDY NAME IN SPANISH]"

    5. User's or insertion manual (as applicable)

    6. Lab test results (issued by the lab that performed the tests):

      1. Biocompatibility, sterility, pyrogenicity, stability, performance, animal studies (GLP is not necessary), etc. (as applicable)

      2. Electrical safety, electromagnetic compatibility, etc. (as applicable)

    7. Software test results as applicable

Source: INVIMA

 

Additional Documents

  • Insurance policy certificate. It must include the following information:

  • Protocol name

  • Investigator(s) name(s)

  • Site name(s) and address(es).

  • Number of patients that it will cover in Colombia

  • Adverse events (detailed description, exclusions, in what instances, etc.) and death

  • Whether the amount of insurance coverage is for an individual patient or for the total number of patients that will be recruited in Colombia 

  • Preferably issued locally by a Colombian insurance company

  • It must be valid during the duration of the study (at least two years is recommended)

  • Investigator's brochure

  • CVs of all the parties involved (investigator(s), study coordinator(s), technical personnel)

  • Study/project timeline (Gantt chart; including all other participating countries)

  • Study budget

  • Letter from the sponsor certifying that it trained the investigator in the use of the investigational device and its associated procedure (if applicable)

  • Letter from the Investigator certifying that it accepts to participate in the study

Colombia Medical Device Clinical Trial Reporting requirements

INVIMA requires that the sponsor (or its local legal representative in Colombia/CRO) submits the following reports after the study/trial has been approved. The report must be sent to INVIMA's medical device committee using this form.

  1. Serious and non serious adverse events (as they occur)

  2. Follow-up (every six months)

  3. Final device usage accountability report (end of the study)

  4. Study close-out

Colombia medical device clinical trial approval timeline

Colombian legislation does not provide a defined timeline for the review and approval of medical device clinical trial application. However, normally INVIMA takes about 30 days to assess and approve the application; the approval may take additional time if further documentation is requested. Protocol submission must be sent to INVIMA's medical device committee by the dates specified below. 

Colombia investigational medical device import permit process

You must obtain a import permit approval with the Ministry of Industry, Commerce and Tourism (VUCE office) —for each shipment—. This will allow you to legally import the investigational product and additional accessories named on the clinical supply list sent with the INVIMA study submission. The average processing time is between 5 to 10 business days.