A Comparative Study of Medical Device Regulations:.

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  • Additional Information
    • Publication Year:
      2018
    • Subject Terms:
    • Author-Supplied Keywords:
      effectiveness
      harmonization
      IMDRF
      regulatory reform
      safety
    • NAICS/Industry Codes:
      NAICS/Industry Codes 417930 Professional machinery, equipment and supplies merchant wholesalers
      339112 Surgical and Medical Instrument Manufacturing
      339110 Medical equipment and supplies manufacturing
      811219 Other Electronic and Precision Equipment Repair and Maintenance
      423450 Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
      541420 Industrial Design Services
    • Abstract:
      The medical device industry is an industry dealing with multiple types of products covering a wide range of applications. As the safety and effectiveness of medical devices are vital to human health, the products must be managed by strict regulations according to the different risk levels. A total product life cycle regulatory system including product design, manufacture, premarket gate keeping, and postmarket monitoring is a common framework for medical device regulations. However, the variety and innovativeness of medical devices are challenging the current regulatory frameworks. Hence, the competent authorities responsible for medical devices worldwide keep renewing their regulatory systems to ensure the safety and effectiveness of medical devices. This review aims to provide an informative review of the regulatory frameworks of medical devices in the United States, Europe, Canada, and Taiwan, with a particular focus on updated regulatory changes in these countries and the current status of global harmonization on medical devices. [ABSTRACT FROM AUTHOR]
    • Abstract:
      Copyright of Therapeutic Innovation & Regulatory Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
    • ISSN:
      21684790
    • Accession Number:
      127141640
  • Citations
    • ABNT:
      CHEN, Y.-J. et al. A Comparative Study of Medical Device Regulations: Therapeutic Innovation & Regulatory Science, [s. l.], v. 52, n. 1, p. 62–69, 2018. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edo&AN=127141640. Acesso em: 25 nov. 2020.
    • AMA:
      Chen Y-J, Chiou C-M, Huang Y-W, Tu P-W, Lee Y-C, Chien C-H. A Comparative Study of Medical Device Regulations: Therapeutic Innovation & Regulatory Science. 2018;52(1):62-69. Accessed November 25, 2020. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edo&AN=127141640
    • APA:
      Chen, Y.-J., Chiou, C.-M., Huang, Y.-W., Tu, P.-W., Lee, Y.-C., & Chien, C.-H. (2018). A Comparative Study of Medical Device Regulations: Therapeutic Innovation & Regulatory Science, 52(1), 62–69.
    • Chicago/Turabian: Author-Date:
      Chen, Yi-Jung, Chi-Ming Chiou, Yu-Wen Huang, Pei-Weng Tu, Yung-Chuan Lee, and Chia-Hung Chien. 2018. “A Comparative Study of Medical Device Regulations:” Therapeutic Innovation & Regulatory Science 52 (1): 62–69. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edo&AN=127141640.
    • Harvard:
      Chen, Y.-J. et al. (2018) ‘A Comparative Study of Medical Device Regulations’:, Therapeutic Innovation & Regulatory Science, 52(1), pp. 62–69. Available at: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edo&AN=127141640 (Accessed: 25 November 2020).
    • Harvard: Australian:
      Chen, Y-J, Chiou, C-M, Huang, Y-W, Tu, P-W, Lee, Y-C & Chien, C-H 2018, ‘A Comparative Study of Medical Device Regulations’:, Therapeutic Innovation & Regulatory Science, vol. 52, no. 1, pp. 62–69, viewed 25 November 2020, .
    • MLA:
      Chen, Yi-Jung, et al. “A Comparative Study of Medical Device Regulations:” Therapeutic Innovation & Regulatory Science, vol. 52, no. 1, Jan. 2018, pp. 62–69. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edo&AN=127141640.
    • Chicago/Turabian: Humanities:
      Chen, Yi-Jung, Chi-Ming Chiou, Yu-Wen Huang, Pei-Weng Tu, Yung-Chuan Lee, and Chia-Hung Chien. “A Comparative Study of Medical Device Regulations:” Therapeutic Innovation & Regulatory Science 52, no. 1 (January 2018): 62–69. http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edo&AN=127141640.
    • Vancouver/ICMJE:
      Chen Y-J, Chiou C-M, Huang Y-W, Tu P-W, Lee Y-C, Chien C-H. A Comparative Study of Medical Device Regulations: Therapeutic Innovation & Regulatory Science [Internet]. 2018 Jan [cited 2020 Nov 25];52(1):62–9. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edo&AN=127141640