Semantic standard and coding for Medical Devices and IVDs in Colombia

Colombian Ministry of Health issued Resolution No. 1405/2022 by which it decided to implement a semantic standard and coding for medical devices (DM in Spanish) and reagents (RDIV in Spanish) in order to facilitate the operability with products that require identification, denomination and classification.

Semantic standard has the following attributes:

Basic: i) identification according to UDI-DI, ii) GMDN code, iii) GMDN term, iv)registration number, v) code issuing agency.

Regulatory: i) Manufacturing information, ii) risk classification according to local legislation, iii) special storage conditions, iv)package special conditions.

Commercial: i) commercial description e.g. trademark or tradename, ii) Commercial presentation e.g. box, package, jar, iii) minimum consumption unit.

The Ministry deemed that INVIMA within the next 18 months (from August 5, 2022 until February 5, 2024) will implement DM and RDIV semantic standard and coding while owners of health registrations should adopt the codification UDI-DI (code that identifies DM and RDIV) to identify the registered products within the following time-frames:

Registered products:

Medical Devices and Reagents Class III: 12 months afterwards.

Medical Devices Class IIb: 18 months afterwards.

Medical Devices Class IIa: 24 months afterwards

Reagents Class II: 18 months afterwards

Reagents Class I: 24 months afterwards

New applications filed after February 5, 2024 should obtain and report the mentioned code.

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