TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/1233

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Proposed amendments to the “Enforcement Rule of the Medical Devices Act”

Objective

Other (TBT)

Product Covered

Medical Devices

Document Notification

Link to ePing

HSCODE

ICSCODE

11.040 - Medical equipment

Keywords

Human health

Specific Regions

Description

The Proposed amendments to the "Enforcement Rule of the Medical Devices Act" are as follows: _x000D_
1) Establishment of fees for newly developed medical device approval and/or preliminary review_x000D_
   - New fees for applications for manufacturing and/or import approval of newly developed medical devices and preliminary review of technical documents, etc._x000D_
2) Establishment of fee reduction provisions for newly developed medical devices_x000D_
   - Exemption of fees for manufacturing and/or import approval (including the review of technical documents) if a preliminary review application for a newly developed medical device is deemed compliant_x000D_
   - Establishment of a legal basis for reducing or exempting fees if a small and medium-sized enterprise  applies for manufacturing approval (or preliminary review) of newly developed medical devices_x000D_
3) Establishment of a legal basis for exemption from redundant submission of medical device quality managers’ qualification proof documents_x000D_
   - Provision to prevent the repeated submission of qualification verification documents for quality managers in case of their changing employment, provided their qualifications have already been verified

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

Back

Notification Detail :: G/TBT/N/KOR/1233

Link to ePing

App Settings