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Notification Detail :: G/TBT/N/KOR/1223
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Proposed establishment of the “Enforcement Dcree of the Digital Medical Products Act” and the “Enforcement Rule of the Digital Medical Products Act”
Objective
Other (TBT)
Product Covered
Digital Medical Products
Document Notification
Link to ePing
HSCODE
ICSCODE
Keywords
Specific Regions
Additional Data
Description
_x000D_ The purpose of this Decree is to prescribe matters mandated by the Digital Medical Products Act for its enactment and enforcement. The matters are as follows:_x000D_ A. details necessary for establishment and implementation of a comprehensive plan for digital medical products_x000D_ B. media and methods of advertising digital medical device software for professionals_x000D_ C. facility standards for medicines combined with digital technology_x000D_ D. procedures and methods for designating institutions for fostering professional human resources, centers for regulatory support, and agencies for certification_x000D_ E. other matters_x000D_ The purpose of this Rule is to prescribe matters mandated by the Digital Medical Products Act and the Enforcement Decree of that Act for its enactment and enforcement. The details are as follows:_x000D_ A. the scope of and classification standards for digital technology_x000D_ B. permission (certification and reporting) considering the characteristics of digital medical devices_x000D_ C. clinical trials (clinical performance tests)_x000D_ D. standards for quality control _x000D_ E. labeling, follow-up management methods and procedures_x000D_ F. certification of excellent management systems_x000D_ G. manufacturing and import of medicines combined with digital technology_x000D_ H. impact assessment for supporting the development of digital medical products_x000D_ I. other metters
Notified Document
1:
File here
Link to Notification
EN:
File here
FR:
File here
ES:
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Status Active
Active
Inactive
Comment
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