Get your first-in-man medical device clinical trial approved 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 INVIMA.

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 by the study

 

 

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

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

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

    15. Duration of the study

    16. Study start date (estimated, worldwide)

    17. Study start date (estimated, Colombia)

    18. Study end date (estimated)

    19. Duration of the subject participation in the study

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

    21. Participating clinical research sites or institutions including,

      1. Physical address

      2. Telephone

      3. Name of investigator (principal and co-investigator)

  2. Study summary

  3. Problem formulation

    1. Problem justification

    2. Proposal justification

    3. Research questions

  4. 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.

  5. 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 tests, etc. (as applicable)

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

    7. Software test results as applicable

  6. Hypothesis (as applicable)

  7. Objectives

    1. General

    2. Specific

  8. 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

  9. Ethical considerations

    1. Approval letter from the local ethics committee for each of the participating research institutions (see Appendix, 12.1)

    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.

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

    3. 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.

  10. Project management

    1. Study/project schedule (Gantt chart; including all other participating countries)

    2. Study budget

    3. 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.

      • Valid during the duration of the study (at least two years is recommended).

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

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

  11. Bibliographic references (Vancouver System/ICMJE)

  12. Appendix

    1. Letter(s) of approval from the local ethics committee at the site(s) where the sponsor plans to conduct the trial. 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.

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

      • Study budget

      • Insurance policy

    2. Original bank deposit slip for the payment of the applicable INVIMA fee (approx. USD $1000).

    3. Credentials of the investigator(s):

      • CV (signed and dated less than 30 days from the date of submission)

      • Copy of his/her national ID card

      • Copy of his/her university and postgraduate graduation certificate

      • Copy of his/her university and postgraduate diploma

      • Copy of the certificate of foreign degree(s) issued by the competent authority (if applicable)

      • Copy of his/her Good Clinical Practice (GCP) training certificate (issued less than two years ago)

    4. Letter from the sponsor certifying that it accepts the investigator(s) at the site(s) in the study.

    5. Letter of acceptance signed by the investigator(s) stating that he/she is willing to participate in the study.

    6. Training certificate or letter issued by the sponsor that states that the investigator(s) was trained on the handling and use of the device.

    7. Clinical Supply List: Detailed and definitive list of medical devices and supplies required for the execution of the protocol and to be imported in Colombia.

    8. Letter from the sponsor transferring obligations to a local entity in Colombia (e.g., CRO). The letter must indicate the final destination site(s) of the investigational devices (used and unused), and what party will be responsible to manage the inventory. This letter must authorize and give power of attorney to the local entity in Colombia (e.g., CRO) to,

      • Submit the study approval application at INVIMA

      • To import, store, ship to site(s), destroy, and export (if applicable) the investigational prototype devices

    9. Medical device disposal/destruction methods and guidelines (not needed as a condition for study approval, but sponsor or CRO must provided this documentation to INVIMA upon study closure along with proof of the disposal/destruction of any investigational products left over after the last patient is recruited and treated. Photos or a letter/certificate from the company contracted to dispose/destroy the investigational products is sufficient proof of the disposal/destruction.

    10. Additional documents that are not required, but recommended to append to the submission if available from the sponsor:

      1. Certificate of compliance with ISO 13485

      2. Statement of compliance in line with relevant essential requirements of Annex I of the European Medical Device Directive (93/42/EEC)

      3. If applicable, an statement regarding human blood derivatives (quality, safety, and usefulness of the substance as part of the device)

      4. If applicable, an statement regarding tissues of animal origin (risk management measures which have been applied to reduce the risk of infection)

Note on items 5.6, 5.7, and 5.8: INVIMA requires that the device’s direct patient risks be mitigated by doing device level tests (i.e.,  biocompatibility, strength test, corrosion test, traceability, etc.). It's up to the sponsor to prove to INVIMA the device's safety by providing as much documentation as the sponsor deems necessary. 

Source: INVIMA

 

Colombia medical device clinical trial approval process

INVIMA's Medical Device and Other Technologies Committee (Sala Especializada de Dispositivos Médicos y Otras Tecnologías in Spanish) meets approximately every 30 days. It reviews study submissions and decides whether the study in question is approved or not and issues meeting minutes to notify the interested party; meeting minutes are then published on INVIMA’s official website approximately one week after the meeting date. 

Colombia medical device clinical trial approval timeline

The legislation does not provide a defined timeline for the review and approval of the clinical trial application. However, normally it 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. 


2018 Colombia's INVIMA medical device committee meeting dates

  • Apr. 11 (submission deadline: Mar. 16)

  • May 16 (submission deadline: Apr. 16)

  • Jun. 13 (submission deadline: May 18)

  • Jul. 11 (submission deadline: Jun. 18)

  • Aug. 15 (submission deadline: Jul 16)

  • Sep. 12 (submission deadline: Aug. 20)

  • Oct. 17 (submission deadline: Sept. 21)

  • Nov. 14 (submission deadline: Oct. 22)

  • Dic. 12 (submission deadline: Nov. 16)

Source: INVIMA

Colombia investigational medical device import permit process

A separate application for an import permit approval to the Ministry of Industry, Commerce and Tourism (VUCE office) —for each shipment— must be obtained to legally import the investigational product and additional accessories named on the clinical supply list sent with the INVIMA submission. The average processing time is between 5 to 10 business days.