Standard specification of medical devices | Amendment of Korean Regulations

Title of document
Amendment of "Regulations on standard specification of medical devices” (31 page(s), in Korean)

Description
The Ministry of Food and Drug Safety (MFDS) has newly established standard specifications for 'Syringe, filter', 'Needle, filter' and 'Needle, filter, reusable' to clarify the test specifications and methods for quality control of filtration performance of these products.

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/808

Objective tag
Protection of human health or safety

Objective
Promoting the health and safety of patients and medical professionals

Documents

• 19_0387_00_x.pdf

Agency responsible
Ministry of Food and Drug Safety

Timing:

• Submission: 22/01/2019
• Reception: 22/01/2019
• Distribution: 23/01/2019
• Final date for comments: 24/03/2019
• Proposed date of adoption: N/A