Medical Device Clinical Trial Protocol Approval in Colombia


 
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Medical Device Clinical Trial Site Selection and Study Approval in Colombia

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Interventional Concepts can 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). 

Prior to submission to INVIMA, the research protocol must be sent to a local ethics committee. Each local committee has its own scheduling and processing times.

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

All research on human beings shall be evaluated and approved by the local ethics committee affiliated to the site where the trial will be conducted. The committee 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.

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
 

INVIMA Document Requirements for Medical Device Clinical Trial Approval

 

  1. COVER LETTER REQUESTING THE STUDY PROTOCOL APPROVAL

    1. Protocol name and version
    2. Participating clinical research sites or institutions including,
      1. Physical address
      2. Telephone
      3. Contact person
    3. Investigator(s) name
  2. STUDY SUMMARY

  3. PROBLEM FORMULATION

    1. Problem justification
    2. Proposal justification
    3. Research questions
  4. THEORETICAL/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.

  1. 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. Electric safety and electromagnetic compatibility study results, among others (as applicable)
    8. Software test results as applicable
  2. HYPOTHESIS (as applicable)

  3. OBJECTIVES

    1. General
    2. Specific
  4. 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 or 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
  5. ETHICAL CONSIDERATIONS

    1. Approval letter from the local Ethics Committee for each of the participating research institutions
    2. Patient’s Informed Consent (according to Article 15 and 16, Ministry of Health’s Resolution No. 8430 of 1993)
  6. PROJECT MANAGEMENT

    1. Timeline
    2. Budget
    3. Insurance policy certificate
      1. Protocol name
      2. Investigator(s) name
      3. Site name and address
      4. Valid during the duration of the study (at least two years is recommended)
      5. List of adverse events that it covers (description of the AE's that will be covered, which ones will not, in what instances, etc.)
      6. Issued by a local Colombian or foreign insurance agency
  7. BIBLIOGRAPHIC REFERENCES (Vancouver System/ICMJE)

  8. APPENDIX

    1. Original bank deposit slip for the payment of the applicable INVIMA fee (approx. USD $1000).
    2. Resume/CV for the investigator(s) (duly signed and dated less than 30 days from the date of submission).
    3. Letter from the sponsor certifying that it accepts the investigator(s) at the site(s) in the study.
    4. Letter of acceptance signed by the investigator(s) stating that he/she is willing to participate in the study.
    5. Training certificate or letter issued by the sponsor that states that the investigator(s) was trained on the handling and use of the device. 
    6. 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.
    7. 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. Statement regarding human blood derivatives
      4. Statement regarding tissues of animal origin

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's official list of requirements for medical device clinical study protocols


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 decides whether the protocol in question is approved or not and issues meeting minutes to notify the interested party, which is published on INVIMA’s official website

Within the approval application, the interested party shall also include the import request for the investigational medical device and all other necessary supplies to run the study. 

Processing Time

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. 


2017 INVIMA Meeting Dates

  • August 9 (submission deadline: July 18)
  • September 13 (submission deadline: August 16)
  • October 11 (submission deadline: September 20)
  • November 8 (submission deadline: October 18)
  • December 13 (submission deadline: November 15)

Import Permit

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. 


NOTES: 

  1. All documents must be translated to the "Colombian" Spanish dialect. The Spanish spoken in Latin America changes from country-to-country and INVIMA has rejected documents such as an Informed Consent Form that is not easily understood by an average native Colombian citizen. 
  2. We recommend that sponsors translate their documents by Colombian Spanish-speaking translators certified by the Colombian Ministry of Foreign Affairs. 
  3. A certified translator is a person who has passed the linguistic proficiency test from the relevant agency designated by the Government of Colombia for this purpose. Any translator who passes this test should take office before the Superior Tribunal of the Judiciary District and apply for a certification from the Ministry of Justice and Law, which will accredit him or her as an official certified translator. The certified translator must register his name with the Ministry of Foreign Affairs by submitting a copy of the Oath of Office and a copy of the certification issued by the Ministry of Justice and Law. 
  4. Interventional Concepts works with local Colombian certified translators duly endorsed by the Ministry of Foreign Affairs (who therefore, hold the relevant certification issued by the Ministry of Justice and Law) with past experience in the clinical research industry. This will certify our sponsor's translations as accurate, faithful and valid to be presented to any government agency such as INVIMA.
  5. A document that has been translated by a certified translator in Colombia will have (by law) the following elements:
    • A "Certified Translation" header.
    • A consecutive certified translation control number.
    • The seal of the official translator in which the translator's full name, his or her certification number issued by the Ministry of Justice, the certification issue date, and the languages that the translator is certified to translate.
    • The signature of the translator in the last page, or at least, the initials of the translator if the document has several pages.
  6. Through a seal and a signature, the translator certifies that the translation is correct and complete and takes responsibility for what is translated. This way, the translator basically acts like a notary authenticating a document. A certified translator is also authorized to be an official interpreter, translating declarations and  affidavits before a notary or a judge.

       

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