The new article clarifies the aspects associated with the designation decision to be taken with respect to the applicant entity in the context of the CAB/NB designation process.
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
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.