
HPRA Guidance on Fees for Human Products: Medical Devices
The new article addresses the matters related to medical devices and associated fees.
The new article addresses the matters related to medical devices and associated fees.
The article provides an overview of the regulatory requirements related to safety in the magnetic resonance environment and highlights the key points to be taken into consideration by medical device manufacturers and other parties involved.
The new article addresses the matters related to interoperability for medical software products.
The article highlights the aspects related to certain specific hazards associated with the use of medical devices in the magnetic resonance environment – namely, displacement force and torque.
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.