China | Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration (Draft)

Title of document
Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration (Draft) (22 page(s), in English; 18 page(s), in Chinese)

Description
According to Article 29 of the Medical Device Act, the Food and Drug Administration, Ministry of Health an Welfare proposes to draft the ''Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration'' to govern the approval and listing of medical device.

Notifying member: Chinese Taipei

Notification: G/TBT/N/TPKM/444

Objective tag
Prevention of deceptive practices and consumer protection

Documents

• 20_7352_00_x.pdf
• 20_7352_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) 2787-7525 Fax: +(886-2) 2653-2006 E-mail: lucy@fda.gov.tw

Timing:

• Submission: 30/11/2020
• Reception: 30/11/2020
• Distribution: 30/11/2020
• Final date for comments: 29/01/2021
• Proposed date of adoption: N/A