English.igj.nl

Our supervision of medical technology Medical …

Medical devices are used for diagnosis or treatment purposes in the healthcare sector. Examples include implants such as pacemakers or prostheses, medical equipment such as MRI scanners, ventilators or surgical instruments, but also may include … See more

Actived: 9 days ago

URL: https://english.igj.nl/medical-technology/our-supervision-of-medical-technology

Home Health and Youth Care Inspectorate

WEBIn the past few years, the Health and Youth Care Inspectorate (IGJ) has laid the foundation for supervising care networks for clients living in home environments with multiple care …

Category: Health Go Health

Investigational medicinal product Medicines Health and …

WEBA medicine for research is denoted internationally by the term ‘Investigational Medicinal Product’ (IMP). The Dutch Medical Research Involving Human Subjects Act (WMO) …

Category: Medical, Medicine Go Health

How we conduct inspections Medicines Health and …

WEBThe Health and Youth Care Inspectorate supervises the enforcement of health legislation as well as oversees the quality of the pharmacovigilance system and ensures that the …

Category: Health Go Health

Supervision of post-market surveillance Medical …

WEBPost-market surveillance (PMS) is an umbrella term that describes a range of activities that a manufacturer must carry out in order to monitor the safety and performance of the …

Category: Health Go Health

Inspections Medical Technology Health and Youth Care …

WEBThe Health and Youth Care Inspectorate [Inspectie Gezondheidszorg en Jeugd] (IGJ) supervises the performance, safety and safe usage of medical devices and in vitro …

Category: Medical Go Health

Production (GMP) Medicines Health and Youth Care …

WEBThe Dutch Health and Youth Care Inspectorate (IGJ) monitors the manufacturers of medicinal products. Manufacturers who produce medicinal products for human use must …

Category: Health Go Health

Medical Technology Health and Youth Care Inspectorate …

WEBDocuments. Medical technology is about products, technologies and applications used in the diagnosis, treatment and support of diseases and disorders. The Inspectorate …

Category: Medical Go Health

Distribution (GDP) Medicines Health and Youth Care …

WEBThe Dutch Health and Youth Care Inspectorate (IGJ) monitors the entire distribution chain for medicinal products and active pharmaceutical ingredients (APIs). If …

Category: Health Go Health

Medicines Health and Youth Care Inspectorate

WEBGood Laboratory Practice (GLP) Pharmacovigilance (PhV) Medicines without marketing authorization. Documents. On these pages you will find more information for …

Category: Medicine Go Health

New legislation: EU Regulation 536/2014 Medicines Health and …

WEBRegulation 536/2014 will replace Directive 2001/20/EC. For clinical trials with medicinal products it is important that the rights, safety, dignity and well-being of the subjects are …

Category: Health Go Health

Documents Health and Youth Care Inspectorate

WEBIGJ assessment framework: Deployment of eHealth by healthcare providers. The assessment framework in this booklet is the starting point for supervision by the Dutch …

Category: Health Go Health

Notification of product defects and recalls Medicines Health and

WEBReporting product defects. Anyone who puts a medicinal product on the market in the Netherlands is obliged to report quality defects to the Dutch Healthcare Inspectorate …

Category: Health Go Health

Vigilance: reporting incidents and corrective actions

WEBVigilance relates to the activities associated with detecting, assessing, understanding and preventing the dangerous adverse effects of medical devices. Vigilance is an element of …

Category: Medical Go Health

Authorised representatives of medical devices do not always meet …

WEBAuthorised representatives are an essential link in the chain of ensuring safe and effective medical devices across the European Union. The Dutch Health and Youth …

Category: Medical Go Health

GMP inspections and GMP certificates Medicines Health and

WEBThe principles of GMP are defined in law and described in EU Directive 2017/1572/EU and Delegated Regulation (EU) 2017/1569. The Dutch Health and Youth Care Inspectorate …

Category: Health Go Health

Registration of economic operator in EUDAMED Medical …

WEBThe new regulations for the market authorisation of medical devices (MDR, EU/745) and in vitro diagnostic medical devices (IVDR, EU/746) imply certain changes. One important …

Category: Medical Go Health

Appeal to manufacturers: take action to meet IVDR requirements

WEBThe Dutch Health and Youth Care Inspectorate (IGJ) has conducted a survey of Netherlands-based manufacturers of medical devices for in vitro diagnostics (IVDs). …

Category: Medical Go Health

Medicines without marketing authorization Medicines Health …

WEBThe Dutch Medicines Act (Geneesmiddelenwet, GnW) prohibits the sale, distribution or supply of any pharmaceutical product (medicine) which has not been registered and …

Category: Medicine Go Health