Template for Risk-Assessment Questionnaire Pharmacovigilance
This template is to help marketing authorization holders (MAHs) during the collection of information from different departments ...
Notice to manufacturers nasal and mouth sprays
The Health and Youth Care Inspectorate as market surveillance authority for medical devices in The Netherlands, would like to ...
GLP domestic test facilities
GLP: Non-domestic test facilities
Restrictions in IGJ on-site inspections due to safety risks
During national or international crises, on-site GxP inspections may not be possible for a number of reasons such as travel ...
IGJ assessment framework: Deployment of eHealth by healthcare providers
The assessment framework in this booklet is the starting point for supervision by the Dutch Health and Youth Care Inspectorate ...
FAQ about inducements (Medical Devices Act)
Guidance on the Management of Clinical Trial during the COVID-19 (Coronavirus) pandemic
Due to the corona crisis the source data verification for the majority of the clinical trials conducted is severely hampered. ...
A: Relevant legislation
B: Clinical investigations involving the use of medical devices – regime