Documents

GLP domestic test facilities

Publication | 02-10-2023

GLP: Non-domestic test facilities

Publication | 02-10-2023

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 ...

Publication | 05-09-2023

Template for Risk-Assessment Questionnaire Pharmacovigilance

This template is to help marketing authorization holders (MAHs) during the collection of information from different departments ...

Publication | 02-02-2023

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 ...

Letter | 14-11-2022

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 ...

Publication | 20-09-2022

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 ...

Publication | 25-11-2021

FAQ about inducements (Medical Devices Act)

Report | 28-05-2021

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. ...

Publication | 23-02-2021

A: Relevant legislation

Publication | 01-10-2020