REGULATORY AFFAIRS IN COLOMBIA
Regulatory Affairs for
Medical Devices and IVDs
We help medical device and IVD companies obtain and maintain INVIMA registrations through clear, strategic and reliable regulatory support.
OUR SERVICES
Regulatory Support From Start To Market
Medical Devices and In Vitro Diagnostic Devices (IVDs)
New registrations · Renewals · Modifications
We manage the regulatory process before INVIMA, from the initial dossier assessment and submission to post-market regulatory maintenance.
INVIMA Registrations
Modifications, renewals and regulatory updates
Registration amendments · Renewals · INVIMA requirements
We support the ongoing maintenance of INVIMA registrations, including technical and legal amendments, renewals, responses to regulatory requirements, and product updates.
Post-Market Regulatory Management
Unique Device Identification reporting in Colombia
Data review · INVIMA reporting · Submission records
We review product information, prepare UDI-DI data and manage its submission before INVIMA, providing clear documentation and traceability throughout the process.
UDI-DI Compliance
Regulatory documentation prepared for Colombia
Translations · Document review · Dossier organization
We coordinate Spanish translations and review regulatory documentation to ensure consistency, completeness and readiness for submission to INVIMA.
Translations & Dossier Support
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A CLEAR PATHWAY TO REGULATORY COMPLIANCE
We guide each project through a structured, transparent and carefully managed regulatory process.
01 — Assessment
We evaluate the product, regulatory classification and applicable requirements in Colombia.
OUR PROCESS
02 — Dossier Preparation
We review and organize the documentation, identify gaps and coordinate the required translations.
03 — Submission & Follow-Up
We manage the submission before INVIMA, monitor its progress and address regulatory requirements.
04 — Ongoing Compliance
We support renewals, modifications, UDI-DI reporting and the continued maintenance of registrations.
Regulatory expertise with a practical approach
Global ProTrade is a regulatory consulting firm specialized in medical devices and In Vitro Diagnostic Devices (IVDs) in Colombia.
We support international manufacturers, importers and distributors throughout the regulatory process before INVIMA, from the initial assessment and preparation of documentation to registration maintenance and post-market requirements.
Our approach combines regulatory knowledge, clear communication and close follow-up, helping our clients navigate Colombian requirements efficiently and with confidence.
Specialized in Colombia
Deep understanding of INVIMA regulatory requirements.
ABOUT US
International Support
Experience working with manufacturers and documentation from different markets.
Close Follow-Up
Clear communication and continuous support throughout the regulatory process.
CONTACT
Let’s discuss your regulatory needs
Whether you are planning a new registration, managing an existing INVIMA registration or need support with regulatory compliance, our team can assist you throughout the process.
We work with manufacturers, importers, distributors and healthcare companies in Colombia and international markets.
Global ProTrade
Regulatory Affairs for Medical Devices & IVDs in Colombia
Contact
WhatsApp: +57 315 646 6212
Email: regulatory@glprotrade.com