Columbia: procedures not related to the COVID-19 emergency
In accordance with the provisions of Resolution No. 2020012926 of April 3, 2020 “By means of which temporary administrative measures are adopted within the framework of the health emergency declared by the National Government due to COVID-19” , it is reported that those procedures that do not correspond to situations derived from the pandemic caused by COVID-19, will be received physically by our correspondence channel, exclusively through courier companies by certified mail.
It should be clarified that there will be no physical contact with users , only the receipt of certified correspondence.
The correspondence will be received at Carrera 10 # 64 – 28, first floor, in the city of Bogotá DC, addressed to the Invima Correspondence Office, only between the hours of 7:30 am to 12:00 pm.
For more information please see the official communication from INVIMA in local language.
Meditrial can help, Contact us now
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Table of Contents
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
