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

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

Notification: G/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

• 20_3958_00_e.pdf
• 20_3958_00_x.pdf

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: nlopolymer@fda.gov.tw

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