The Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd or IGJ) is the Dutch government agency within the Ministry of Health, Welfare and Sport responsible for public health policies. The IGJ was formed in 2017 with the merger of two institutions: the Dutch Healthcare Inspectorate and the Dutch Inspectorate for Youth Care.
The IGJ supervises almost all aspects of Dutch healthcare (e.g., physiotherapists, dentists, hospitals, long-stay care units, IVD laboratories, psychiatrists, etc.). Together with medicinal products, the section for Medical Technology oversees medical products as part of the work of the IGJ. The supervision is based on European legislation supported by specific Dutch legislation. Part of this task is to oversee investigations of incidents by providers of care and/or medical products or to perform independent investigations. For medical devices, the IGJ also oversees the activities of Dutch Notified Bodies (DEKRA, BSI, and LRQA).
A list of EU regulations can be found here on our website.
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为了获得澳大利亚市场准入,医疗器械和体外诊断(IVD)器械制造商需要将他们的产品列入由药品管理局(TGA)监管的澳大利亚医疗用品登记表(ARTG)。
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