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).
A guide on the types of application for the evaluation of the conformance in the quality management of medical devices
Initial conformance evaluation
- Manufacture : At the time of the application for an initial product permit (reporting) and a permit for a medical device manufacturing business.
- Importation : At the time of the application for the permit for the medical device importation business and the initial importation item permit (reporting) - A conformance evaluation will be conducted on the manufacturer.
Regular assessment
To be applied every three years after obtaining the initial conformance certificate or a pass certificate as a result of a regular assessment.
※ The application must be submitted by no later than 90 days before the expiry.
Additional assessment (for adding product categories)
In the case of trying to import and sell a product group that is not included in the existing quality management criteria conformance certificate in South Korea, it is required to receive a conformance evaluation to add a new category.
Change assessment (relocation)
If the manufacturing facility in the country or overseas is relocated, an evaluation will be conducted by visiting the site of the applicant.
Review of complementary documents
This is a process to make corrections with the required 'complementation issues' identified during an evaluation (initial regular or addition) and conform that such corrections are made.
※ Be advised that a failure to make such corrections by the required date (within 30 days) or the re-evaluation reveals that the complementation was not realized, the final result will be 'disqualification.'
How to prepare the conformance evaluation request form for medical device quality management criteria.
Applicant
- In the 'Business Permit (Report) Number" box, input the importation business permit number.
- Fill in the "Address" area with the address of the manufacturer as per the manufacturing business permit. For an importation business, the address in the importation permit (the office address) must be provided. Be advised that the application form must be prepared for each manufacturer.
Person-in-charge (quality officer)
In the box for the name of the person-in-charge, provide the name and phone number of the quality officer.
Evaluation type
Tick the type of evaluation according to the purpose of the application.
Evaluation Items
- List the items for which the applying business has already obtained permits (or reported.) If there are too many items, submit a separate list of items of application, by referring to the preparation guideline.
- As for the categories, refer to the categories for medical devices.
Address in English and how to provide it. (The name of the business, representative, and address)
- Provide the name of the business, name of the representative, and address both in Korean and English.
- Korea Post: koreapost.go.kr
Conformance evaluation cost
- The conformance certification cost is to be filled by the reception officer of KTC. The applicant must leave this box empty.
- Evaluation cost + travel cost = Appropriate cost
The preferred date of evaluation
You must provide the preferred date of evaluation.
Applicant
Name of the representativeof the business that applies for the conformance evaluation, along with the signature or the seal.
* As for the person-in-charge of application, please provide the contact mobile phone number of the person who is in charge of the quality management documents.
The list of the documents to be submitted for the conformance evaluation for medical device manufacture and quality management criteria
Precautions for submitting documents
- Only the application documents shall be submitted (marked 'O.')
- If one wishes to obtain the conformance certification on production and quality management criteria, at least one or more units of past quality management reference is required.
(However, if it is difficult to submit the information in 2-H and 2-J, such can be checked during a field inspection.)
- When making an application for the conformance evaluation for making an addition to the grades or product categories, submit the documents for additional evaluation. For changing the address of the manufacturer, submit the document for a change assessment.
- If the importer is submitting the requests for all of its foreign manufacturers, submit a summarization table of the foreign manufacturers (if applicable) (Form No. 1) (Rear)
- The addresses of the foreign manufacturers shall be consistent in the item permits and the certificate for the manufacturer.
- A copy of the product permit for the representative item (of the highest grade, highest importation volume, or the items with importation or sales references), the front pages of all product permits available (the explanations for the difference between the manufacturer and the clients who commissioned the production for a foreign maker, -required)
- The total number of the employees shall be provided separately for the different departments engaged in.
- The list of facilities and equipment shall include the production facilities, machinery, and test facilities/instruments.
- The address and scope of services of the key suppliers apply to the supplier of the key raw materials.
- The conformance certificates from other accreditation bodies include the quality certificates as per ISO 13485 and others that are related to the quality of medical devices.
- The quality manual shall be documented as per the requirements ISO 13485 (the criteria for the domestic medical devices production quality management), including quality policies and include the subordinate quality documents (procedures) structure or table of contents.
- The product standard of the applicable category shall cover, for the representative items of each category, the name of the item, model name, classification number, grade, shape, raw material-related information, key work processes, how to use, precautions for use, label indications, cleanliness management criteria (if applicable), sterilization (if applicable)- the test criteria of the company (the safety and performance test included in the latest quality test standard)
- If the import product permit indicates the separate manufacturer and the client who commissioned the manufacturing of the products, the documents that clearly delineate the scope of services for the production (such as a written contract), both the documents of the client and the manufacturer.
- For a complement evaluation, an official letter concerning the submission of the complementation document shall be submitted along with the complementation documents.
- When the application/complementation documents are submitted, all documents must be signed by the quality officer or equivalent. And valid documents must be submitted.
The medical device GMP evaluation reference documents
| 01 |
The criteria for manufacturing and quality management of medical devices (2019.3.25) Download |
| 02 |
The detailed guidelines for the GMP evaluation of foreign manufacturer of imported medical devices (MFDS, Jul. 2019) Download |
| 03 |
The enforcement rules for medical devices (2019.06.12) Download |
| 04 |
The Rules of the Classes and Grades of the Items in Each Class of Medical Devices Download |
| 05 |
The medical devices categorization table Download |
| 06 |
The GMP handbook for medical devices Download |
| 07 |
(Manufacturer) A sample quality manual Download |
| 08 |
(Manufacturer) A sample of quality procedure Download |
| 09 |
The evaluation guidelines for training among the medical devices GMP/GIP standard Download |
| 10 |
The management of the medical devices permits due to the use of the 'street name address.' Download |
| 11 |
GMP evaluation request form Download |
| 12 |
GMP refund request Download |
The re-issuance/replacement issuance of the GMP/GIP conformance certificates for medical devices
| 01 |
The Rules of the Classes and Grades of the Items in Each Class of Medical Devices (2019.06.20) Download |
Visit the website of the responsible department
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