The Health Care Inspectorate (Inspectie voor Gezondheidszorg or IGZ) is the Dutch government agency part of the Ministry of Health, Welfare and Sport responsible for public health policies. The IGZ was formed in 1995 with the merger of three insistutions: the Medical Inspectorate of Health , the Medical Inspectorate for Mental Health and the Drug Inspectorate.
The IGZ supervises the enforcement of health legislation, investigates incidents, deals with both Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance as well as oversees the activity of DEKRA Certification, the ‘notified body’ for the Netherlands. It also oversees the quality of medical devices, their usage and ensures the manufacturers comply with existing European regulations.
Some of the most important European regulations for medical devices in the EU are:
- CONSOLIDATED Medical Device Directive (93/42/EEC)
- CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
- Personal Protective Equipment Directive (89/686/EEC)
A full list of EU regulations can be found here.
- Website: http://www.igz.nl/english/
Medical Device Associations in The Netherlands: