Medical Devices Competent Authority Netherlands

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Registration of a medical device or IVD | Medical …

https://english.igj.nl/medical-technology/market-authorisation/registration-and-deregistration

National registration of a medical device is a statutory obligation (Dutch Medical Devices Act, Section 24/25) and helps the Inspectorate carry out its supervisory remit in respect of these devices. Registration of medical devices and in vitro diagnostic devices This concerns the registration (notification) of Dutch manufact… See more

Medical devices: MDR and IVDR in the Netherlands

https://business.gov.nl/sector-specific/care-and-animal-care/medicines-and-medical-technologies/medical-devices-mdr-and-ivdr/

Medical devices includes many products and services: from bandages to medical apps to pregnancy tests. The new European regulations may have serious implications for …

Rules for manufacturing and using medical devices

https://business.gov.nl/regulation/medical-devices/

For Class I medical devices (non-sterile and/or non-measuring) you assess if the product complies with the Medical Devices Directive yourself. If this is the case, you may put the …

List of Competent Authorities for Medical Devices - AKRN

https://akrnconsulting.com/list-member-states-competent-authorities-for-medical-devices/

The competent authority belongs to the government of the Member State of the European Union (EU) and their responsibility is to transposes the requirements of …

National competent authorities (human) | European …

https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human

List of national competent authorities in the EEA. Information on coronavirus …

Medical Device Registration and Approval in Netherlands

https://arazygroup.com/medical-device-registration-netherlands/

In the Netherlands, devices are regulated by the Ministry of Health, Welfare and Sport Agency, CIBG Farmatec. CLASSIFICATION SYSTEM: Medical devices are classified …

Competent authority: CCMO or Ministry of Health, …

https://english.ccmo.nl/investigators/research-with-a-medicinal-product-extra-review-competent-authority/competent-authority-ccmo-or-ministry-of-health-welfare-and-sport

the competent authority (CCMO or Ministry of Health, Welfare and Sport). The CCMO acts as competent authority for research with a medicinal product that is reviewed by an …

Notifications | Medical devices and in vitro diagnostic

https://english.farmatec.nl/medical-devices/notifications

The government encourages parties to complete registrations for MDR and IVDR-compliant procedure packs, Class I medical devices or in vitro diagnostic medical devices in …

Ministry of Health, Welfare and Sport

https://www.government.nl/ministries/ministry-of-health-welfare-and-sport

Everyone in the Netherlands has health insurance that covers a broad range of treatment and care. The ministry works with health insurers, providers and patient …

Contact Points of National Authorities

https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en

[email protected]

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