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NORMATIVE GUIDELINE[removed]20th December.2005 NOTIFICATIONS OF MEDICAL DEVICES TO THE PRODUCT REGISTER Legal basis Sections 14, and 15 and section 30, subsection 5 of the Medical Devices Act
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Document Date: 2012-12-20 02:04:53


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City

Helsinki / /

Country

Finland / /

Facility

Ombudsman Safety Technology Authority VTT Technical Research Centre of Finland State Provincial Offices / /

IndustryTerm

medical device / diagnostic medical device / certain medical devices / sterilization services / procedure packs5 comprising medical devices / electricity / certain devices / Active implantable device / medical devices / active implantable devices / active implanted devices / advertising material / to those medical devices / in vitro diagnostic devices / non-disposable products / devices / reagent product / in-vitro diagnostic medical devices / obesity treatment medical laser devices / individual medical devices / diagnostic medical devices / /

MedicalCondition

disease / sterility / congenital abnormality / injury / obesity / both sterility / /

MedicalTreatment

dental implants / /

Organization

Social Affairs and Health National Research and Development Centre for Welfare and Health / Ministry of Social Affairs and Health / Åland Patient Insurance Centre Association / Finnish Health Care Technology Association / Ombudsman Safety Technology Authority VTT Technical Research Centre of Finland State Provincial offices of Finland State Provincial office / Finland Union of Health / National Agency for Medicines / Pharmaceutical Distributors Union of Denturists / Finnish Nurses Association Association of Ophthalmic Opticians / Finnish Dental Association Finnish Union / Finland Finnish Pharmacists’ Association Finnish Federation / National Agency for Medicine / Local and Regional Authorities Association / Radiation and Nuclear Safety Authority National Authority / Finland Association of Dental Laboratories Pharma Industry Finland SAI-LAB / Medicolegal Affairs Consumer Agency / National Agency for Medicines Medical Devices Product Register POB / Finnish Pharmacies International Society for Prosthetics and Orthotics / Ministry of Health / Justice Data Protection Ombudsman Ministry of Social Affairs / /

Person

Kirsti Kotaniemi / Hannes Wahlroos / /

/

Position

authorised representative / Director General / Professor / physician / calibrator / control material / Chancellor / representative / Director General / /

Technology

Radiation / laser / in vitro diagnostics / /

URL

www.nam.fi/publications/forms / /

SocialTag