• July 17, 2020
  • WTO

Draft of Regulations on Good Clinical Practice for Medical Devices (15 page(s), in English; 19 page(s), in Chinese)


Your substances

None


Title of document
Draft of Regulations on Good Clinical Practice for Medical Devices (15 page(s), in English; 19 page(s), in Chinese)

Description
According to the design, conduct, recording, and reporting of clinical investigations, the regulation is intended to develop a complete management mechanism for clinical investigations on medical devices, to protect the rights, safety, and well-being of subjects and to ensure that the conduction of clinical investigations conforms to ethical and scientific principles.

Notifying member: Chinese Taipei

NotificationG/TBT/N/TPKM/420

Objective tag
Protection of human health or safety

Objective
To protect the rights, safety, and well-being of subjects and to ensure that the conduction of clinical investigations conforms to ethical and scientific principles.

Documents


Agency responsible
Food and Drug Administration Ministry of Health and Welfare Bldg. F, No.99, Ln. 130, Sec. 1, Academia Rd. Nangang District, Taipei City 11561, Taiwan Tel.: (886-2)2787-8087 Email: [email protected]

Timing:

  • Submission: 29/06/2020
  • Reception: 29/06/2020
  • Distribution: 29/06/2020
  • Final date for comments: 28/08/2020
  • Proposed date of adoption: N/A

                   

Related News

Loading...