Australia
The new article describes in detail the key points related to the regulatory requirements applicable to the specific groups of products, namely medical systems and procedure packs.
Australia
The new article clarifies the particular conformity assessment procedure to be applied in the context of medical device systems and procedure packs.
Australia
The new article describes some aspects related to the information accompanying the products.
It provides additional clarifications regarding the parties’ obligations as set forth under the existing legal framework.
Saudi Arabia
The article provides a general overview of the regulatory approach to be applied concerning biotechnology-based medical devices intended to be marketed and used in Saudi Arabia.
Canada
This article highlights the critical points related to the procedures to be followed by medical device manufacturers and other parties involved in case changes to medical devices allowed for marketing and use in Canada.
Turkey
The article provides a general overview of the regulatory framework for medical devices with measuring functions.
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