Documents
38 documents
- Date
- Relevance
-
GLP domestic test facilities
-
GLP: Non-domestic test facilities
-
Appeal to manufacturers: take action to meet IVDR requirements
The Dutch Health and Youth Care Inspectorate (IGJ) has conducted a survey of Netherlands-based manufacturers of medical devices ...
-
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 ...
-
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