Recently, INVIMA has released a resolution regarding the semantic report (a tool for identifying products based on UDI codes -more details below), marking a significant development in the regulation of medical devices and in vitro diagnostic reagents (IVDs) in Colombia. In this article, we will delve into this new process and explore its key aspects to help stakeholders navigate the requirements.
Semantic Report
On February the 8th, 2024, INVIMA enabled a web platform to facilitate reporting under the semantic standard for medical devices and IVDs, as mandated by the Resolution 1405 of 2022. This resolution outlines the attributes and coding standards for these products to be commercialized in the Colombian market, defining adoption and implementation procedures along with associated deadlines.
The semantic report is the tool for identifying, designating, and classifying medical devices and IVDs. This will be enhancing traceability and information exchange among stakeholders involved in product commercialization, it also contributes to improve regulatory compliance and market surveillance. For this standardization Colombia has adopted the Unique Device Identifier (UDI) codes.
Transitory Period
For the industry to report under this new scheme, INVIMA has granted a period for current sanitary registrations to be updated in accordance with the Resolution 1405 of 2022.
For already approved sanitary registrations and modifications as of February the 7th, 2024, a transitional status applies based on the product classification:
- Class III medical devices and Category III IVDs: 12 months transition period (until February the 8th, 2025).
- Class IIb medical devices and Category II IVDs: 18 months transition period (until August the 8th, 2025).
- Class IIa and I medical devices and Category I IVDs: 24 months transition period (until February the 8th, 2026).
It is worth mentioning that this transition status does not apply to registrations granted after February the 8th, 2024.
Key stakeholders
The semantic reporting process involves active participation from various stakeholders, including:
- The Holder of the sanitary registration, who assumes responsibility to execute the semantic report process.
- Manufacturer and/or brand owner, tasked with procuring UDI-DI codes from certified agencies.
- INVIMA, authority that verifies the information submitted via the designated web platform and granting approval for commercialization.
Attributes for the Semantic Report
The report encompasses three attribute categories: basic, regulatory, and commercial, which cover essential information related to the product identification, regulatory compliance, and commercialization.
Process
The semantic report process involves four key steps:
- Obtain the INVIMA approval for the sanitary registration.
- Obtain UDI-DI codes from the manufacturer, certified by relevant agencies.
- Submit the semantic report through INVIMA’s website, exclusively by the holder of the sanitary registration.
- Pay INVIMA fee to receive the electronic document that guarantees the completion of the report.
Conclusion
While the implementation of this new process is ongoing, it is recommended to start with the information compilation to do the report and be in compliance with the Resolution 1405 of 2022. For further guidance on navigating this process, please contact us at contact@veraqueconsulting.com
