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By establishing the Department for Medical Devices and modifying the role of Notified Bodies the conformity assessment procedure and the law enforcement activity became separated as it was expected by the EU.
The family of medical devices consists of many kinds of devices including for example orthopaedic instep-raiser, X-ray equipment and hip-joint prosthesis. Due to the wide range of devices the relevant regulation and the conformity assessment procedure based on the regulation is managed in a fairly sophisticated way.
We are intended to give a hand to the manufacturers, the users and the fellow authorities to find the way in this complicated legislative surrounding with our home page. The reader is kindly asked to let us know his notices in a letter, fax or e-mail sent to the address available in this material for the success of our intention.
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Last Updated (2010.04.12)
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Law Enfocement Procedures
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The role of the Department for Medical Devices
as a law enforcement national Authority
Supervises the national market of medical devices in cooperation with the National Public Health and Medical Officer Service (Allami Nepegeszsegugyi es Tisztiorvosi Szolgalat) and the Hungarian Authority for Consumer Protection (Nemzeti Fogyasztóvédelmi Hatóság) in respect of fulfilling the Essential Requirements of placing devices on the market. Takes appropriate actions against the devices violating the relevant regulation with suspending the use or distribution, or withdrawing them from the market. |
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Last Updated (2010.04.12)
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Legal Status, Organisation
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The legal status and the organisation of the Department The Department for Medical Devices of the Office of Health Authorisation and Administrative Procedures is an independent organization of the Health Care Administration, financed by the Government. The Department for Medical Devices was established on the 1st April, 2000 by the order of the Minister of Health. The deed of foundation was published in the official journal of the Ministry of Health, No 2000/7. |
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Last Updated (2010.04.12)
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The Staff - Name
- Responsible
- Language
- Room
- E-mail
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Last Updated (2010.04.12)
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The procedure of the Authority shall be governed by the Act CXL of 2004 on the General Rules of Administrative Official Procedures and Services. The language of the official procedures is Hungarian. About the resolutions The resolutions issued by the Authority are unappealable but revision from the court can be requested. At the moment the Authority deals mostly with domestic cases however as one of the Member States of the EU Hungary is obliged to fulfil the same obligations as the Member States in the territory of Hungary, notifying the fellow Competent Authorities of the EU about the resolutions. |
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Last Updated (2009.12.03)
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