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DRAFT GUIDANCE DOCUMENT Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications
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Document Date: 2013-06-24 11:44:43


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File Size: 110,35 KB

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City

Ottawa / /

Company

Electronic Applications Health Canada / Premarket Review / /

Country

Canada / /

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Event

Product Recall / Product Issues / /

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IndustryTerm

non-in vitro diagnostic devices / device licence applications / above-noted medical devices / diagnostic devices / licence applications / device licence amendment applications / premarket licence applications / health products / medical device licence applications / medical device licence amendment applications / therapeutic product / final device / premarket device licence applications / diagnostic device / licence amendment applications / regulatory systems / amendment applications / combination products / non-in vitro diagnostic medical devices / sterilization processing characteristics / medical device applications / food / /

Organization

Health Products and Food Branch / Global Harmonization Task Force / /

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Position

senior official / Executive / Minister of Health / Minister of Public Works / General / Premarket Information Cover Letter Executive / /

Product

Standards / /

ProvinceOrState

Ontario / /

PublishedMedium

Conformity / /

Technology

digital video / /

URL

http /

SocialTag