Preparing for 26 February 2026: a practical checklist
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Classification, representative, dossier, e-imzo — what to have ready before the new regime applies.
With Resolution No. 738 applying from 26 February 2026, manufacturers should work backwards from that date.
First, determine the safety class. The regime uses four risk-based classes, and the class drives both the evidence burden and the review path. Second, decide the route: recognition if the device holds a US FDA, EU CE, UK MHRA, Japan PMDA or Korea MFDS approval, otherwise the national pathway. Third, appoint the Authorized Representative and execute the Power of Attorney, allowing time for legalisation and certified translation. Fourth, assemble the dossier — technical documentation, clinical evaluation, labelling and instructions for use in the required languages, and quality management evidence. Fifth, obtain e-imzo credentials for whoever will sign the submission.
Registration certificates are issued for five years, so build the renewal date into the lifecycle plan from the start.