The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.
RegDesk Regulatory Roundup
The new article highlights the aspects related to the vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
The article provides a general overview of the existing regulatory framework associated with adverse events.