News - News
14 news items
Face masks from China and US equivalent to European
Certain face masks approved for use outside the EU (e.g. China and the US) are equivalent to FFP2 and FFP3 face masks that comply ...
Personal protective equipment in the healthcare sector subject to export licence
An export licence is required for the export of personal protective equipment, such as face masks, splash goggles, and gloves, to ...
Instruction to register the supply of alternative medical devices
A manufacturer, authorised representative, distributor, or importer can register the supply of an alternative medical device with ...
Coronavirus: More flexibility for manufacturers and suppliers in case of shortages of medical equipment
As a result of the coronavirus outbreak, there may be shortages of the medical devices. The Health and Youth Care Inspectorate ...
Coronavirus: consequences for GMP and GDP inspections and certificates
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Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO)
The COVID-19 pandemic affects health care services and the society in general. The conduct of clinical trials and trial subjects ...
Warning with regard to self-testing for coronavirus
Home tests for determining whether you are carrier of the coronavirus are forbidden unless they have first been assessed by a ...
Coronavirus: what to do in case of a shortage of medical equipment
As a result of the coronavirus outbreak, medical equipment normally used may no longer be available due to shortages. In that ...
Macro-textured breast implants not withdrawn from the market (in the Netherlands)
The Health and Youth Care Inspectorate [Inspectie Gezondheidszorg en Jeugd] believe that that there is currently insufficient ...
IGJ response to Trouw and Radar reporting about medical implants
Attention for the safety of medical devices is increasing. Recent years have shown that serious problems can occur, particularly ...