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.
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
Malaysia
The article describes in detail certain aspects to be considered when applying grouping criteria for medical devices intended to be marketed and used in Malaysia.
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