Competent Authority Medical Devices Ireland

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Medical devices regulatory information - HPRA

https://www.hpra.ie/homepage/medical-devices/regulatory-information

Examples of medical devices include hospital beds, surgical instruments, syringes, wheelchairs, walking frames, contact lenses, condoms, heart valves, pacemakers, hip implants, MRI machines and more. What is an IVD? An IVD is a medical device that is a …

Medical Devices - HPRA

https://www.hpra.ie/homepage/medical-devices

The objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety …

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 …

gov.ie - Healthcare, Medicines and Medical Products

https://www.gov.ie/en/publication/b2f783-healthcare-medicines-medical-products/

The HPRA, the national competent authority for medicines, is supporting stakeholders in managing the regulatory and operational implications arising from Brexit. …

Ireland Medical Device Registration - HPRA Approval

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

Medical Device Regulations and Classification in Ireland REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Ireland, …

The Essential List of Regulatory Authorities …

https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu

To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website (s) for each country’s ministry of health …

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 disease (COVID-19) ...

gov.ie - Intermediate Products

https://www.gov.ie/en/publication/9c13a-intermediate-products/

(a) a registered establishment or plant for the production of laboratory reagents, medical devices and in vitro diagnostic medical devices or the derived …

Competent Authority, Notified Body, Authorized Representative

https://www.rimsys.io/blog/eu-competent-authority-notified-body-authorized-representative

There is an umbrella group called the Competent Authorities for Medical Devices (CAMD) that is responsible for improving communication and collaborative work between these …

List of national authorities for Medical Devices

https://easymedicaldevice.com/list-national-authorities-medical-devices/

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – – Department of Medical Devices Surveillance, Vigilance and Clinical Trials Al. …

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