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).
The conformance evaluation process diagram with manufacturing, importation, and quality management criteria
The detailed processes of the conformance evaluation with the manufacturing, importation, and quality management criteria.
Application for conformance evaluation
- The manufacturer or importer of medical devices for clinical trials shall, before the commencement of the clinical trial, obtain the permit for the manufacturing and importation business of medical devices and then receive the evaluation for conformance with the quality management criteria before starting the sales of the said medical device.
- Even if the medical devices belong to the same group, she must grade them as Grade 1 through 4. Or, if a medical device of another group is added, the conformance evaluation must be conducted anew.
※ In the case of a medical device of Grade 1 (excluding sterilized medical devices) only the Sections 4.1, 4.2, 5.5, 6.4, 7.1, 7.4, 7.5, 7.6, 8.2.1, 8.2.2, 8.2.3, 8.2.6, 8.3, and 8.5 in Table 1, "The Criteria and Checklist for the Conformance Evaluation with the Criteria for Manufacturing and Quality Management of Medical Devices" shall apply.
- Cases where a field inspection is required (a new factory, regular renewal assessment, changes with the production site or addition of a new site, newly developed medical devices, non-conformities identified within the last three years, failure to submit the required documents for an overseas production site.)
※ A change of the representative, upgrading, or adding sterilization does not require an assessment.
Documents required
- The application form for the conformance evaluation with the medical device quality management criteria
- A copy of the medical devices manufacturing or importation business permit or the conditional permit for the said businesses (excluding the medical devices for clinical trials)>
- Quality manual, product standard, and other quality management documents
※ For the detailed list of the required documents, See the 'Guidance for Preparing the Application Documents.'
Application received
Conformance evaluations can be applied to all product categories. However, the application is accepted only when the required documents and fees are submitted to KTC.
Preliminary review
A review of the required documents and the information provided in the forms, etc.
※ A copy of the medical devices manufacturing or importation business permit or the conditional permit for the said businesses (excluding the medical devices for clinical trials) is required. Minor discrepancies are advised to the applicant for supplementation.
Negotiation for the conditions of selecting the medical device monitor and the date of evaluation
KTC negotiates with the MFDS regarding the medical device monitor and the date of evaluation in consideration of the preferred date of evaluation submitted by the applicant.
Notification of the medical device monitor and the date of evaluation
The MFDS informs KTC of the medical device monitor and the date of evaluation.
The notification of the schedule for the conformance evaluation schedule and assessment plan
- Once the monitor and date are confirmed, KTC notifies and submits the date of evaluation and evaluation plan document to the applicant and the MFDS.
- The evaluation plan (audit plan) shall include the following information;
- The date of evaluation
- The scope and purpose of evaluation
- The formation of the evaluation committee
- Detailed evaluation plans and the expected time is taken
- The participants, including the manufacturer, importer, and quality management officer, etc.
The execution of the conformance evaluation
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- Kick-off meeting
- · The introduction of the members of the manufacturer, importer, quality management officer, monitor, and the evaluators of KTC.
- ※ The representatives or representatives of the manufacturer must be present during the kick-off meeting, managerial review meeting, and close-up meeting.
- ※ As a principle, consultants, other manufacturer or importers, cannot participate in the evaluation process. However, the manufacturer to be evaluated or other manufacturers or importers that the MFDS agreed upon may participate in the meeting.
- · The confirmation of the scope and purpose of the evaluation.
- ※ Confirmation of whether the medical device is for mass production or for a clinical trial; whether this is the initial evaluation, regular renewal assessment, or change evaluation, etc.
- · A briefing on the schedule and process of the evaluation
- · Determination of the official communication arrangement between the evaluation team and the manufacturer
- · Q&A
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- The conformance evaluation with the quality management criteria
- · Conformance evaluation according to the evaluation plan (audit plan).
- ※ Evaluation of the current status of quality management, including field evaluation and quality document reviews.
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- General evaluation meeting of the evaluation committee
- · The meeting of the evaluation committee composed of quality evaluators and medical device monitors.
- ※ The evaluation committee conducts a general evaluation. The meeting is restricted to the medical device manufacturer, importer, or consultants.
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- Close-up meeting
- · The evaluation committee explains the observations and required complementation to the manufacturer, importer, and quality officer and hands over the evaluation report.
- · The conformance table is prepared and signed by the medical device monitor, quality evaluator, and representatives.
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- Issuance of the supplementation request; conformance certificate
- · Based on the result of the general evaluation and after going through the internal approval process of KTC, a conformance certificate or a complementation request is issued and notified to the MFDs and the applicant.
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- The time of complementation and sales/clinical trials execution
- · Once a conformance certificate is issued, the medical device may be sold in the market or used in a clinical trial.
- · If there is a complement request, submit the corrections and complements.
- ※ If complements are required as a result of the conformance evaluation, the complement is to be made within a one-month period. The manufacturer shall, after making the corrections and complementation, submit a letter requesting a re-evaluation.
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