Colombia Document Requirements for Medical Device Clinical Trials

Conducting clinical trials of medical devices in Colombia is a process that requires adequate documentation to ensure the safety and efficacy of the products before they reach the market. The regulation of these studies is overseen by the National Institute for Food and Drug Surveillance (INVIMA), which establishes the requirements for the approval and monitoring of clinical trials. In this article, we will explore in detail some of the required documents that need to be considered:

• Cover Letter

  • Study title.

  • Protocol version.

  • The number of patients that will be enrolled.

  • Study start and end date.

  • Contact information for the research center(s), contact information for the investigator (principal investigator and sub-investigator), and other relevant information.

• Study Documents

  • Study protocol: It must follow strict academic research methodology standards and include a summary, a problem formulation, a theoretical and conceptual framework, information about the investigational device, the hypothesis, the objectives, the methodology, and bibliographic references (Vancouver System / ICMJE).

  • Investigator’s brochure.

  • Case report form (CRF)

• Ethical Documents

  • Approval letter from the institutional review board (IRB) / ethics committee (EC) for each of the participating research centers/sites.

  • Informed consent form (ICF).

  • Subject recruitment material (if applicable). Proof of the existence of the EC (i.e., incorporation certificate, contract with the research center).

• Principal Investigator Documents

  • CVs of the research team.

  • Certificate of completion of GCP training for the research team.

  • Letter from the sponsor certifying that it trained the investigators in using the investigational device and its associated procedure (if applicable).

  • Letter from the investigator certifying that he/she accepts to participate in the study.

• Additional Documents

  • Study/project timeline (Gantt chart).

  • Study budget.

  • Letter from the sponsor authorizing a local entity in Colombia to obtain approval and carry out the study.

  • Clinical supply list.

  • Disposal/destruction methods and guidelines.

  • Lab test results as applicable (biocompatibility, sterility, pyrogenicity, stability, performance, animal studies, electrical safety, electromagnetic compatibility).

  • Patient ID card (if applicable).

  • Label artwork.

  • Proof of clinical trial registration (e.g., clinicaltrials.gov, International Clinical Trials Registry Platform (ICTRP), ISRCTN, European Union Clinical Trials Register (EU-CTR)

  Each of these aspects is crucial for the proper conduct of clinical trials and compliance with current regulations, thus ensuring the integrity of the process and the protection of participants.