Overview
As the quality management evaluation organization, according to the MEDICAL DEVICES ACT, we are conducting the conformance evaluations based on the quality management criteria for medical devices for production and clinical trials, in accordance with the "Quality Management and Production Criteria for Medical Devices."
Scope of program
- The conformance assessment with the product quality management criteria as per the MEDICAL DEVICES ACT
- The conformance assessment with the quality management criteria for clinical trial medical devices
Quality management according to the MEDICAL DEVICES ACT
Legal basis
- The MEDICAL DEVICES ACT, its Enforcement Decree, and Enforcement Rules
- The Production and Quality Management Criteria for Medical Devices (Announcement by MFDS)
Scope of application
Applicable only to the manufacturers of medical devices, including foreign manufacturers. (The importers are allowed to sell the products
- The manufacturers of medical devices
- The manufacturers (importers) of the medical devices for clinical trials
The types of assessments
- Initial assessment (The businesses with the initial permit and the business permit certificate 1. Only applicable for the assignment and acquisition of the initially issued permit.)
- Complementation assessment (If the assessment result requires minor complementation, only the submission of documents may suffice.)
- Additional assessment (applicable to the cases with differences with the items of the initial permit.)
- Change assessment (applicable to the cases where the production site has been relocated from the original location in the permit.)
- Importer: Field assessment of the overseas production site and documentary reviews
Items groups and classifications for the conformance evaluation with quality management criteria
In consideration of the intent of the quality management system and the characteristics of various medical devices, the conformance evaluations shall be conducted by dividing the existing 26 classes into different grades (Grade 1 through 4).
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