Medical Health

Korea's only public comprehensive testing and certification organization Customer makes KTL

Customer makes KTL

Business

Medical Health

In accordance with Clause 1 of Article 7 of Enforcement Regulations of the Medical Device Act, review technical documents (2nd rated medical device)

Overview
- In accordance with Article 27 of Medical Device Act, test the safety and functions of medical devices.
Business Fields
- Test and evaluate in accordance with “Common Standards and Specifications for
- Electromechanical Safety of Medical Devices”
- Test and evaluate in accordance with “Common Standards and Specifications for Electromagnetic Safety of Medical Devices”
- Test and evaluate in accordance with “Standard Criteria of Electrical Medical Devices”
- Test and evaluate in accordance with “Announcement of Same Products of Medical Devices”
- Test and evaluate the performance of medical devices
- Inspect imported and used medical devices in advance
- Consigned test and inspect ( Consigned test for quality control of manufacturers and import companies)
- Test and evaluate medical devices for international certifications

Overview
- As we are designated as an inspection agency for medical devices by Food and Drug Administration, we not only test overall medical supplies/ dental materials but also perform a variety of technical support required during product development and quality control.
Business Fields
- Biological safety test
- Evaluate functions and physical physicochemical mechanic characteristics
- Consigned test for quality control
- Evaluate the process validation

Overview
- In accordance with Medical Device Act, assess the production of medical devices and suitability of quality control standards
Applicable Items
- Manufacturing medical devices, import medical devices, and medical devices for clinical test

Ministry of Food and Drugs Safety (MFDS) established an organization in 1998 within KTL in order to foster and support the medical device industry in Korea.
Website of Medical Devices Quality Support Center (http://www.ktlmedi.re.kr)