GRTPNZ
The new article provides further clarifications on certain specific aspects associated with the regulatory requirements healthcare products, including medicines and medical devices, should comply with in order to be allowed for marketing and use in New Zealand.
Medsafe
The new article explains the approach to be applied with respect to different categories of healthcare products based on specific criteria.
AIaMD
The article provides a general overview of the new regulatory framework for innovative AI-based healthcare products intended to be marketed and used in the UK.
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
EU
The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
