ANVISA
The new article covers the matters related to classification of personalised devices and provides additional clarifications in this respect.
EU
The final article of the cycle is dedicated to combination products and their specific regulatory nature.
EU
The new article further elaborates on the key matters associated with substance-based products intended to be marketed and used within the EU.
EU
The new article describes in detail the regulatory status of herbal products.
Medical Devices
The European Union Medical Device Regulation (EU MDR) significantly reshaped the landscape for medical device manufacturers, introducing stringent regulatory requirements aimed at enhancing patient safety and device efficacy. Enforced since May 2021, the MDR replaced the older Medical Device Directive (MDD), demanding greater transparency and accountability from manufacturers operating within the EU market.
Tanzania
The final article of the cycle provides clarifications regarding the remaining specific aspects addressed in the document, finalizing the overview of the existing legal framework and highlighting the key points to be taken into consideration by the parties involved.
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