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Medical devices

Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices

Template of Declaration of conformity contents (There are no translations available)


Important links about medical device regulation:

  • European Commission - Medical Device Sector:

http://ec.europa.eu/enterprise/medical_devices/index_en.htm

  • Guidelines relating to Medical Device Directives:

http://ec.europa.eu/consumers/sectors/medical_devices/documents/guidelines/index_en.htm

  • Global Harmonization in Medical Device Regulation. Guidelines:

http://www.ghtf.org/whatsnew.html

  • Medical Device Nomenclature Systems:

http://www.ecri.org/Products/Pages/UMDNS.aspx

http://www.gmdnagency.com/?id=nom

 
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