00000nam 2200000zi 4500 9.882298 CaOODSP 20230612093709 m o d f cr ||||||||||| 191121t20192019onc o f000 0 eng d 9780660333052 CaOODSP eng rda CaOODSP n-cn--- H164-291/1-2019E-PDF Guidance document : software as a medical device (SaMD) : classification examples. Software as a medical device (SaMD) : classification examples Ottawa, ON : Health Canada = Santé Canada, 2019. ©2019 1 online resource (16 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Title from cover. Issued also in HTML format. "Publication date: December 18, 2019." "Date adopted: 2019/10/03." "Effective date: 2019/12/18." Issued also in French under title: Ligne directrices : logiciels à titre d’instruments médicaux (LIM) : exemples de classification. "Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective"--Foreword, page 3. Medical instruments and apparatus Government policy Canada. Canada. Health Canada. Ligne directrices : (CaOODSP)9.882299 Guidance document : (CaOODSP)9.917706 PDF 282 KB https://publications.gc.ca/collections/collection_2020/sc-hc/H164-291-1-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html 190470