As the third-largest medical device market in Latin America, Colombia, with a population exceeding 50 million, presents a significant opportunity for international medical device companies. Over 80% of its medical devices and IVDs are supplied by foreign manufacturers, underscoring the importance of INVIMA Colombia Medical Device Registration for those looking to expand their footprint in this key market.
On 16 December 2025, the EU published Proposal 2025/0404 (COD) to simplify MDR and IVDR requirements. Key measures include revised software classification rules, reduced re-certification obligations, expanded eIFU use, participation in MDSAP, increased flexibility for in-house devices, and new pathways for orphan and breakthrough innovations—aiming to reduce burden while maintaining patient safety.
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