Malaysia
The article provides a general overview of grouping requirements applicable in Malaysia.
United States
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
United States
The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
EU
The article provides a general overview of the regulatory concepts associated with demonstrating substantial equivalence for specific products intended to be marketed and used in the EU.
EU
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
