HSA Guidance on Medical Device Product Registration: Class C and D
The new article describes the regulatory requirements concerning high-risk products – Class C and D medical devices.
The new article describes the regulatory requirements concerning high-risk products – Class C and D medical devices.
The article highlights the critical points associated with clinical practice inspections in Pakistan.
The new article describes in detail the relevant inspection process, highlighting the key points to be considered by the parties involved.
The new article addresses specific aspects related to GCP inspections, including, among other things, the ones associated with reporting, the checklist to be followed, and necessary documentation.
The article provides a general overview of the regulatory requirements for software medical devices intended to be marketed and used in Singapore.
The new article provides additional details regarding the quality management system, explaining how it should be implemented in software medical devices.