HPRA
The article provides a general overview of the regulatory requirements applicable to medical devices created and manufactured by healthcare institutions to meet their own internal needs.
HPRA
The new article describes in detail the requirements in-house IVDs are subject to.
HPRA
The new article elaborates more on the specific frameworks applicable to in-house IVDs allowed for manufacture and use in Ireland.
HPRA
The article highlights the key points related to the current regulatory framework for clinical investigations conducted in Ireland.
HPRA
The article addresses the aspects related to the fees payable in the context of authorization for medical device manufacturers, wholesalers, and distributors.
HPRA
The new article addresses the matters related to medical devices and associated fees.
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