EDA Guidance on Reporting Adverse Reactions: Responsibilities of Users
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.
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.