00000nam 2200000zi 4500 9.940313 CaOODSP 20240712150847 m o d f cr |n||||||||| 240709e20210510onc ob f00| 0 eng d CaOODSP eng rda CaOODSP n-cn--- H164-377/2021E-PDF Issue identification paper : drug-device combination products (DDCPS) : draft for consultation. Drug-device combination products (DDCPS) [Ottawa] : Health Canada = Santé Canada, May 10, 2021. 1 online resource (13 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Documentation de détermination des enjeux : produits mixtes médicaments-instruments médicaux : ébauche aux fins de consultation. "Draft date: 2021/05/10." Includes bibliographical references (page 13). "This paper is intended to identify the key challenges associated with Health Canada’s oversight of drug-device combination products (DDCPs) as per Health Canada’s Policy on Drug/Medical Device Combination Products (the Policy). DDCPs are health products that combine drugs and medical devices as a single entity. For the purposes of this paper, a drug is considered to be a pharmaceutical, radiopharmaceutical, natural health product (NHP), biologic, cell, tissue, organ, gene therapy, or human blood and its components"--Objective, page 3. Medical instruments and apparatus Government policy Canada. Drugs Government policy Canada. Canada. Health Canada, issuing body. Documentation de détermination des enjeux : (CaOODSP)9.940560 PDF 265 KB https://publications.gc.ca/collections/collection_2024/sc-hc/H164-377-2021-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/programs/consultation-issue-identification-paper-drug-device-combination-products-draft/document.html