Archived
Fall 2019 FAQs (Medical Devices)
Information
Type
Policy
Regulated products
IVDMD, Medical Devices
Published
January 2, 2020
Description
2019 Second Half Frequently Asked Questions (Medical Devices)Chapter 1 Medical Device Permits and Reports1. Questions about medical device permits for one set2. Questions about permits in case of transfer of items3. Questions about existing permits due to changes in MFDS standards4. Questions about administrative penalties for failure to apply for periodic review5. Questions about management of product standards for discontinued types6. Questions about safety validation after resterilization of Class 2 in vitro medical supplies7. Questions about expiration of GMP certificate of conformity for importers8.
Tags
Organization
Country / Region
South Korea
License
Other (Public Domain)