Archived
Change in vitro diagnostic medical device model names on the fly!
Information
Type
Policy
Regulated products
IVDMD, Medical Devices
Published
December 10, 2020
Description
You can change the model name of your in vitro diagnostic medical device right away!Two notices have been revised to improve the in vitro diagnostic medical device approval and examination system□ The Ministry of Food and Drug Safety (MFDS) has revised the "Regulations on In Vitro Diagnostic Medical Device Permit, Report, Examination, etc." and "Regulations on Approval of Clinical Performance Test Plan for In Vitro Diagnostic Medical Devices" to revitalize in vitro diagnostic medical device research, development, and commercialization...
Tags
Organization
Country / Region
South Korea
License
Other (Public Domain)