Guidelines for correct PMC labeling
With the decree of the Director General of 17 December 2024, the Ministry of Health published the guidelines for the correct labeling of medical-surgical devices (PMC).
The main objective of these guidelines is twofold:
- Protect consumers, ensuring that product information is clear, correct and not misleading, so as to encourage informed purchases and uses.
- Help companies avoid errors in labeling, which could lead to criminal sanctions.
The guidelines apply from 20 December 2024 for new authorisation requests (including amendments/extensions of the same).
Products already authorised before 20 December 2024 do not need to be modified, but it must be ensured that the labels that are on the market are identical to the authorised ones, in all their parts.
If you are a customer, access the reserved area with the credentials previously sent for the entire in-depth Alert.
Contact us for any further clarifications or specific needs.
Chimica HTS supports companies in verifying compliance based on the regulations in force.
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