Documents
39 documents
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IGJ Policy plan 2024-2027
A great deal is happening in the world – both close by and in far-flung places. These are developments that likewise have an ...
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GLP domestic test facilities
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GLP: Non-domestic test facilities
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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 ...
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Template for Risk-Assessment Questionnaire Pharmacovigilance
This template is to help marketing authorization holders (MAHs) during the collection of information from different departments ...
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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 ...
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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 ...
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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 ...
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FAQ about inducements (Medical Devices Act)
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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. ...