China | Regulations Governing the Classification of Medical Devices (Draft)

Title of document
Regulations Governing the Classification of Medical Devices (Draft) (225 page(s), in English; 163 page(s), in Chinese)

Description
According to Paragraph 2, Articles 3 of the Medical Device Act, the Food and Drug Administration (FDA), Ministry of Health and Welfare, proposes to draft "Regulations Governing the Classification of Medical Devices", which govern the classification of the medical devices.

Notifying member: Chinese Taipei

Notification: G/TBT/N/TPKM/432

Objective tag
Prevention of deceptive practices and consumer protection

Documents

• 20_5408_00_x.pdf
• 20_5408_00_e.pdf

Agency responsible
Food and Drug Administration (FDA) Ministry of Health and Welfare No.161-2, Kunyang St., Nangang Dist. Taipei City 115-61, Taiwan Tel: +(886-2) 2787-7581 Fax: +(886-2) 2653-2006 E-mail: hsiuhuipeng@fda.gov.tw

Timing:

• Submission: 10/09/2020
• Reception: 14/09/2020
• Distribution: 14/09/2020
• Final date for comments: 13/11/2020
• Proposed date of adoption: N/A