Documents
41 documents
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Inspections in the field of medicines, blood and tissues
In the Netherlands, the Health and Youth Care Inspectorate (HYCI) is the supervisory authority for the quality, safety and ...
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Call to medical device manufacturers: implement an effective PMS system
The Health and Youth Care Inspectorate (IGJ) supervises post-market surveillance (PMS) at manufacturers of (in-vitro diagnostic) ...
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Authorised representatives of medical devices do not always meet the basic requirements
Authorised representatives are an essential link in the chain of ensuring safe and effective medical devices across the European ...
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GLP domestic test facilities
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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: 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 ...