Medsafe Guidelines on the Regulation of Therapeutic Products: Key Elements
The new article describes in detail the key elements of the regulatory system for healthcare products.
The new article describes in detail the key elements of the regulatory system for healthcare products.
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.
The new article explains the approach to be applied with respect to different categories of healthcare products based on specific criteria.
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.
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
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