. 6. " " ( ).,., published by the Commissioner of Korea Food & Drug Administration (hereafter "Commissioner") based on the standards

Transcription

1 1 1 ( ) ,. 2 ( ). 1. " ",,,, ( ), ( )., ( " " ) " ". 3. " " " " 2. Chapter 1 General Provisions Article 1 (Purpose) The purpose of these Regulations is to specify details on approval, license, notification, product notification, etc. of manufactured and imported Medical Devices as set forth in Paragraph 5 of Article 5 and Paragraph 3 of Article 18 of the Enforcement Regulations of the Medical Device Act. Article 2 (Definition) The definitions of the terms used herein are as mentioned below: 1. "Same Product Group"means a product group consisting of a series of products (series products) which have different colors, sizes, etc., or of which components are changed or to which components are added, provided that they have the same purposeof use, use method, manufacturing method, and raw materials (only for medical instruments and dental materials), among the Medical Devices whose country of production, manufacturer, and product item name are same, with the exception of the cases requiring submission of data mentioned in Item 2, Paragraph 2, Article 7 of the Enforcement Regulations of the Medical Device Act (hereafter "Enforcement Regulations") since the structure, principle, performance, purpose of use, use method, etc. of the product items are not essentially equivalent to those of the approved product items. 2. "Single-use Medical Devices" mean Medical Devices that are intended to be used one time or to be used for one patient at one procedure. 3. "Combined Medical Device" means two or more Medical Devices combined into one Medical Device, which perform combined or improved functions. 4. "Composite Medical Device" means Medical Devices formed in one packing unit by composing two or more Medical Devices into one set or system. 5. " " ( " " ) 5. "Recognized Standards" mean standards that are separately specified and

2 . 6. " " ( ).,., published by the Commissioner of Korea Food & Drug Administration (hereafter "Commissioner") based on the standards recognized in Korea and overseas. 6. "Recognized Standards-Complying Medical Devices"mean Medical Devices with the standard structures and performance specifications among class 2 Medical Devices with minor potential risk to the human body, which are separately specified and published by the Commissioner. Chapter 2 Product Manufacture License, Product Import License, Etc. Article 3 ( Product license, Etc.) In case that the products in respect of which a product license is desired to be applied for or a product notification is desired to be filed fall under the Same Product Group, such products can be covered in a single product license application or a single product notification. The product name of a Combined Medical Device shall be classified as a Medical Device performing the major function among the component Medical Devices of such Combined Medical Device, and if each of the component Medical Devices of a Combined Medical Device has different classes, such Combined Medical Device shall be classified into the class of the Medical Device having the highest risk among the component Medical Devices of such Combined Medical Device. However, if each of the component Medical Devices of the Combined Medical Device is separated from the Combined Medical Device, a product license shall be obtained, or a product notification shall be filed, for each Medical Device. For Composite Medical Devices, product license shall be obtained or product notification shall be made as follows: 1. The product name of a Composite Medical Device shall be classified as the Medical Device performing the main purpose of use or functions of the Composite Medical Device, and the middle-category name may be used; 2. If each of the component Medical Devices of a Composite Medical Device has a different class, such Composite Medical Device shall be classified into the classof the component Medical Device having the highest risk among such

3 3., ( ), , , , , 2.,. 4 ( ) 5 18 component Medical Devices; and 3. When, for a Composite Medical Device, a product license is obtained or a product notification is filed, classification number, commercial name (classification name and model name), and class of each of the component Medical Devices of such Composite Medical Device shall be mentioned. With respect to a Combined Medical Device or a Composite Medical Device for which a product license has already been obtained or a product notification has already been filed under the above Paragraphs 2 and 3, if a product license is intended to be obtained or a product notification to be made for each ofthe component Medical Devices of such Combined Medical Device or such Composite Medical Device, documents mentioned in Items 1 through 3, Paragraph 1, Article 5, and Items 1 through 3, Paragraph 1, Article 18 of the Enforcement Regulations may not be submitted for purposes of the product license, and, documents mentioned in Items 2 through 3, Paragraph 1, Article 5, and Items 2 through 3 of Paragraph 1 of Article 18 of the Enforcement Regulations may not be submitted for purposes of the product notification. For products for which a long time is required to determine the classification, such as newly developed Medical Devices, etc., product license can be obtained or product notification made using a middle-category name or a separately specified classification name, and classification code. In this case, the classification criteria under Article 2 of the Enforcement Regulations shall be applied for classification. The Commissioner shall select Recognized Standards-Complying Medical Devices and the relevant Recognized Standards through a review conducted by the Medical Device Committee, and publish the same on Internet homepage, etc., and in case of adding or changing, or excluding the same, the Commissioner shall make an amended public notice thereof. Article 4 (Application for Product License, Etc.) An application for product manufacture license/ product import license or a product manufacture notification/

4 ( )., (CD, )., ( ) " " " " , ( " " ) 29 ( " " ). 5 ( ) product import notification as provided in Articles 5 and 18 of the Enforcement Regulations shall be prepared in accordance with the Regulations for Reviewing Technical Document, etc. of Medical Device (KFDA Notification). In this case, a dedicated program specified by the Commissioner shall be used or they shall be submitted in electronic media (CD, diskette, etc.). If manufacturing/importing is intended only for export, documents under Item 1, Paragraph 1, Article 5 and Item 3, Paragraph 1, Article 5 of the Enforcement Regulations may not be submitted. In this case, the indication "Only for Export"shall be written in the remarks field of the application for license or notification at the time when the application for product manufacture or import license (notification) is filed. If the product items for which a license has been obtained or a notification has been filed under the above Paragraph 2 is intended to be marketed, a product license shall be obtained or a product notification shall be filed as provided in Articles 5 and 18 of the Enforcement Regulations. Upon filing an application for product import license or a product import notification for used Medical Devices, the indication "Second hand Medical Device"shall be written in the remarks field of such application or notification. If a product license is intended to be applied for with respect to the Recognized Standards-Complying Medical Device as mentioned in Paragraph 6 of Article 3 herein, a test report proving that it is in conformity with the recognized standards shall be submitted in lieu of the documents mentioned in Item 1, Paragraph 1, Article 5 of the Enforcement Regulations; in this case, a test report shall be limited to the one only issued by a testing laboratory (hereinafter "Testing Laboratory") registered with the KFDA as provided in Article 29 of the Medical Device Act (hereafter the "Act"). Article 5 (Quality Management Compliance Certificates for Foreign Manufacturing Places) The quality management compliance certificate for foreign manufacturing places as provided in Item 2, Paragraph 1, Article 18 of the

5 1., 3 2. (BSI, TUV, UL, CSA, DNV ), " " 4. 1 ( ) (KTL, BSI, TUV, UL, CSA, DNV ) ISO ( ) ISO 9001, Enforcement Regulations shall be one of the followings: 6 < > Article 6 Deleted <December 2009 > 7 ( ) ( ) 1. Documents recognizing that the manufacturing place is equivalent to the Manufacturing and Quality Management Standards for Medical Devices under Attached Table 3 of the Enforcement Regulations or in conformity with the higher standards, provided that such documents are issued by the government of the country of production or an agency authorized by the government 2. Documents recognizing that the manufacturing place is equivalent to the Manufacturing and Quality Management Standards for Medical Devices under Attached Table 3 of the Enforcement Regulations or in conformity with the higher standards, provided that such documents are issued by organizations recognized by the Commissioner (BSI, TUV, UL, CSA, DNV, etc.) 3. "Quality Management Standards Compliance Certificate", which is issued by a quality control review agency registered in the KFDA through review under the Manufacturing and Quality Management Standards for Medical Devices as mentioned in Attached Table 3 of the Enforcement Regulations 4. ISO 9001 compliance certificates issued by organizations recognized by the Commissioner (BSI, TUV, UL, CSA, DNV, etc.) if the item is not specified by the government of the country of production as a Medical Device, or if it is a Class 1 Medical Device(except sterile Medical Devices) 5. Test report of a foreign manufacturing place, quality manual, and self-compliance declaration, from which it can be recognized that proper quality control equivalent to ISO 9001 or higher standards is being implemented, in the case of Class 1 Medical Devices (except sterile Medical Devices) for which the government of the country of production does not conduct a review of manufacturing and quality management standards. Article 7 (Examination of the Same Product)Those who intend to get confirmation that the product is the same product of the same manufacturer(in case that the country of production, the manufacturer, and the manufacturing

6 (, ) ( ) Change in model name place are same) under the proviso of Item 1, Paragraph 1, Article 18 of the Enforcement Regulations shall make application to the Commissioner, together with data proving that the product is same as the approved product (manufacturing/distribution certificate, user guide, etc.), and the Commissioner shall notify the result of examination within 10 days. Article 8 (Amended licenses, Etc.) Upon changes in one of the followings, an amended license shall be obtained or an amended notification shall be filed in respect ofsuch changes pursuant to Articles 14 and 21 of the Enforcement Regulations: Addition of Medical Device models that fall under the Same Product Group; Change in components, etc. of a Combined Medical Device or a Composite Medical Device; Change in raw materials; 5., 5. Change in appearance, structure, and size; 6. ( ) 6. Change in manufacturing method(process); Change in performance and purpose of use; Change in instructions for use or operational method; Change in cautions for use; 10. ( ) 10. Change in storage method and valid term(including period of use ); Change in standard specification and test method; Change in packing unit; Change in representative;. A. Change in the representative among the directors of the corporation; or. B. Change in the representative by way of transfer 14. ( ) 14. Change in company name(including the manufacturer of the exporting country in the case of imports); and

7 15. ( ) 15. Change in location (including the manufacturer of the exporting country in the case of imports). < > Deleted <May 12, 2007> ,. 1.,, Upon changes in the licensed matters falling under Items 2 through 11 of Paragraph 1, documents under Item 1, Paragraph 1, Article 5 of the Enforcement Regulations shall be submitted; provided that upon one of the followings, those documents may not be submitted: 1. Change of structural component that does not influence physical strength, change of circuits or wiring, or change of form or position of switches, etc. in the control unit, to the extent that such change does not have an effect on safety and performance of the Medical Device; If change is directed by the Commissioner due to amendment of the standard specifications under Article 18 of the Act or other amendments; and Medical Devices for export only ( ) 4. In case of subcontracting the whole manufacturing process as mentioned in Item 6 of the above Paragraph 1, documents specified in Item 2, Paragraph 1, Article 5 of the Enforcement Regulations shall be submitted. In case of change in the matters specified in Sub-item B, Item 13, Paragraph 1, documents proving the transfer shall be submitted. In case of change of location of the manufacturer in the exporting country as mentioned in Item 15 of the above Paragraph 1, documents specified in Item 2, Paragraph 1, Article 18 of the Enforcement Regulations shall be submitted. Despite Paragraph 1, an amended license shall be deemed to have been obtained, or anamended notification shall be deemed to have been filed, by submitting documents mentioning the relevant changes (including electronic documents) as set forth in Paragraph 4 of Article 14 of the Enforcement Regulations, only to the extent that such changes are minor ones not influencing safety and performance of the Medical Device, as specified in Attached Table 4.

8 ( ) (CD, ) 1 ( " " ). 3 9 ( ) 29 1, 2 6. In case of a minor change as specified in Attached Table 4, the date and description of such change shall be mentioned by the manufacturer or importer in the Description of Change and Disposition, Etc. field on the back of the relevant product license or product notification whenever such change occurs. The manufacturer or importer, regarding changes specified in Attached Table 4, shall submit a product notification as per the Attached Table 4 Form (including an electronic document), together with electronic recording media(cd, diskette, etc.) to the Commissioner of KFDA or the head of the competent local food and drug administration (hereafter referred to as the "Commissioner of Regional KFDA") (i) upon every change or (ii) by the last day of the month of each year (the "Change Submission Date") in which falls the relevant anniversary of the date of the initial license or notification, with respect to changes that occurred during the one- year period ending in the month immediately preceding the month in which the Change Submission Date falls. Chapter 3 Medical Devices for Testing, Etc. Article 9 (Confirmation of Medical Devices for Testing, Etc.) Under Article 29 of the Act, the head of the Testing Laboratory shall issue a certificate for Item 1 and the Commissioner of Regional KFDA shall issue a certificate for Items 2 through 6 below: Medical Devices for testing to obtain import product license; 2.,, 2. Medical Devices for product item designation, class review, quality control standard validation, technical file review, etc.; Medical Devices for clinical trial under approval of the clinical trial plan ; Medical Devices for research for clear research purposes, such as product development Medical Devices for samples for the purpose of identifying the actual size of the product; and Medical Devices for self use for continuous use by a person of the product that has been used by such person during his or her stay abroad, if such person

9 2,, ( ) 1 1, ,. 1 ( ) ( ) desires to use such Medical Devices after returning to Korea. When a person intends to be issued a certificate in order to import Medical Devices for testing, etc., an application shall be made to (i) the head of the Testing Laboratory in the case of Item 1 of Paragraph 1, or (ii) the Commissioner of Regional KFDA in the case of Items 2 through 6 of Paragraph 1, in each case, by attaching the data proving the form, performance, use, etc. of the product (including a use plan) to a certificate for Medical Devices for testing, etc. as per Attached Form No. 2 provided that if technical documents, etc. for Medical Devices have already been reviewed by the Commissioner of Regional KFDA or the clinical trial plan for Medical Devices has been approved, just a use plan shall be submitted among the attachments. If the Commissioner of Regional KFDA or the head of the Testing Laboratory intends to issue a certificate for Medical Devices for testing, etc, they shall examine whether or not it comesunder one of the items mentioned in the above Paragraph 1, as well as appropriateness of the number of the certificates applied for (including a use plan ). Chapter 4 Testing Article 10 (Application for Testing) Those who are to apply for testing of Medical Devices to the Testing Laboratory as specified in Article 29 of the Act shall submit, to a Testing Laboratory, an application as per Attached Form No. 3, together with the following data and the Medical Device for testing: Data on technical documents, etc. of the product as provided in Item 1, Paragraph 1, Article 5 of the Enforcement Regulations; 2., ( ), ( ) 2. In the case of import, as data that can prove the Medical Device for testing, the Standard Customs Prediction Report under the Consolidated Public Notic e (Ministry of Knowledge Economy Notification) and a copy of import report certificate under the Notification of Handling of Import Customs Affairs (Korea Customs Service Notification); and 3. ( Test report (limited to only for test report recognized under Article 13

10 ) 11 ( ).. 1,,, , ( ). herein). Article 11 (Testing) The head of the Testing Laboratory shall perform testing according to the test specification or the test item specified in the technical documents etc. of the product; provided that if the Medical Device comes under a Recognized Standards-Complying Medical Device, testing may be conducted in accordance with the published Recognized Standards. Despite the above Paragraph 1, the head of the Testing Laboratory may make a request for testing to Korean and overseas public testing laboratories, authorized research institutes, colleges, etc. for testing items which cannot be tested in the Testing Laboratory. If there is no specific equipment necessary for testing of the product, other facilities are available. When testing the Same Product Group, the head of the Testing Laboratory may omit any repeated tests related to safety of raw material or the same components. If the test result of the Medical Device tested under Items 1 through 4, Paragraph 1, Article 15 is nonconforming, the head of the Testing Laboratory shall notify the Commissioner of Regional KFDA of the applicant and matters about the product, reason for rejection, etc. The Commissioner of Regional KFDA shall take necessary actions so that a Medical Device notified as nonconforming under the above paragraph 4 shall not be distributed. For Medical Devices requiring installation etc. to perform testing, the head of the Testing Laboratory may conduct testing in the domestic and overseas places where those Medical Devices are installed. Article 12 (Acknowledgment of Test Report) If the applicant submits a test report issued by a Testing Laboratory coming under one of the followings, the head of the Testing Laboratory may examine and acknowledge such report, and if the test report is a copy, it shall be confirmed by the head of the Testing Laboratory or its reliability shall be secured such as by way of notarization, etc.:

11 1. 1. Testing Laboratories for Medical Devices registered in the KFDA; and 2. ( ) ( ) 11 12, ( ) ,. 14 ( ) If the testing laboratory is not registered in the KFDA, an institution issuing a test report under the Regulations for Reviewing Technical Document, etc. of Medical Device (KFDA Notification) or an institution which has entered into a mutual recognition agreement with the Testing Laboratory registered with the KFDA A test report issued by the head of the Testing Laboratory as provided in Paragraph 1 shall be recognized only with respect to the test record under the aforesaid test method recognized by the Commissioner. If the testing requirements are met with respect to some of the test items, only the test results relating to such test items can be recognized. In this case, testing shall be conducted for the other test items as provided in Article 11 herein. Article 13 (Issue of Test Report, Etc.) When testing is conducted as provided in Articles 11 and 12 herein, the head of the Testing Laboratory shall issue a test report as per Attached Form No. 4 of the Regulations on Designation of Testing Laboratory for Drugs Etc., Cosmetics, and Medical Devices (KFDA Notification) according to the result. If the result of total inspection specified in Item 2, Paragraph 1, Article 14 herein is conforming, the head of the Testing Laboratory shall issue a test certificate, and if it is not conforming, shall notify the reason to the applicant for testing and the Commissioner of Regional KFDA. Article 14 (Items for Total Inspection, Etc.) Items subject to total inspection in a Testing Laboratory pursuant to Article 29 of the Act and Item 6, Paragraph 1, Article 20 of the Enforcement Regulations are as follows: 1. In the case of Medical Devices that are recognized by the Commissioner to require specific control for the purpose of protecting citizens health and securing safety and efficacy; and In the case of import of used Medical Devices.

12 ( ). If the result of a final inspection specified in the Manual of Product Specification which is conducted with respect to an importer of used Medical Devices subject to notification is conforming, it shall be deemed that the inspection as provided in Paragraph 1 shall be deemed to have been conducted with respect to such person. Chapter 5 Testing Laboratory, Etc. Article 15 (Services of Testing Laboratory) perform the following services: A Testing Laboratory shall Testing under the Recognized Standards as published pursuant to Paragraph 6 of Article 3 herein; Total inspection under Article 14 herein; Testing required for a review of technical documents, etc. pursuant to Article 7 of the Enforcement Regulations; Medical Device testing requested by the Commissioner of KFDA or the Commissioner of Regional KFDA; and Other Medical Device tests requested by manufacturers/importers.. 16 ( ) ( 248 ), ( ). The Commissioner may designate the fields or items subject to testing with respect to which tests shall be conducted by each Testing Laboratory, so that tests of Medical Devices can be performed professionally and efficiently. Article 16 (Time Limit of Re-examination) Under the Regulations on Issue and Management of Instruction and the Established Rule Etc. (Presidential Instruction No. 248), the time limit within which to take measures such as abolition, amendment, etc. of this Notification through examination of legal or current conditions prevailing after the issuance of this notification shall be by August 24, < > ADDENDUM <March 5, 2005> Article 1 (Effective Date) This notification shall take effect from the date of notification.

13 2 ( ) ( ) 4 2, ( ) 4 3, ( ) " " " ", " ", " ", " " " " , ( ) Article 2 (Interim Measures for Testing Laboratory)An institution, which, as of the effective date hereof, is registered with the KFDA as a medical instrument testing laboratory under the previous Regulations on Approval of Medical Instruments, Etc., shall be deemed to have been registered as a Testing Laboratory for Medical Devices under Article 15 herein. Article 3 (Interim Measures for Application of standards for Manufacturing and Quality Management) Those who, as of the effective date hereof, obtained manufacturing business license and obtained a product manufacture license or filed a product manufacture notification for a medical instrument under the Pharmaceutical Affairs Law shall comply with the Manufacturing and Quality Management Standards for Medical Instruments under Attached Table 4-2 of the former Enforcement Regulations of the Pharmaceutical Affairs Act, and the same is applied when the manufacturer obtains a product manufacture license or files a product manufacture notification for a new product item before May 30, In this case, groups of product items requiring new facilities shall be as set forth in Attached Table 4. Article 4 (Interim Measures for Application of Standards for Import and Quality Management Standards) Those who, as of the effective date hereof, obtained a product import license or filed a product import notification for a medical instrument under the Pharmaceutical Affairs Law shall comply with the Quality Management Standards for Imported Products under Attached Table 4-3 of the former Enforcement Regulations of the Pharmaceutical Affairs Law, and the same is applied when the importer obtains a product import license or files a product import notification for a new item before May 30, In this case, items requiring new facilities shall be as mentioned in Attached Table 4. Article 5 (Interim Measures for Newly Designated Products) The "Glasses against radiation", "Scooter for medical use ", "Densitometer, bone, x-ray", "Leisure products including swimming spectacles among sight corrective spectacles" and "Material, denture, adhesive", which are newly classified by class and notified in the "Regulations on Product classifications of Medical Devices and Class by

14 . 6 ( ) ( , ).. products" can be manufactured and imported by December 31, 2005 according to the previous regulations, but, from January 1, 2006, can be manufactured or imported only by those who obtained a product manufacture license (product import license) or filed a product manufacture notification (or product import notification) with respect to such products as Medical Devices. Article 6 (Abolition of Other Notifications) The Regulations on Approval, Etc. of Medical Instruments (KFDA Notification No , October 13, 2003) shall be abolished at the same time as the enforcement of these Regulations. < > ADDENDUM <November 3, 2005> This notification shall take effect from the date of notification. < > ADDENDUM < > This provision shall take effect from October 1, < > ADDENDUM < > This notification shall take effect from the date of notification. However, Article 9 shall take effect 30 days after notification. < > ADDENDUM < > 1 ( )., ( ) Article 1 (Effective Date) This notification shall take effect from the date of notification. However, the amended provisions of Article 9 shall take effect from October 1, Article 2 (Interim Measures for Confirmation of Medical Devices for Testing Etc.) Issuance of a certificate in respect of the Medical Devices for testing, etc., for which an application for issuance was filed under Paragraph 2 of Article 9 herein before enforcement of this Notification, shall be as set forth in the previous provisions. < , > ADDENDUM <No , August 24, 2009> This notification shall take effect from the date of notification. < , > ADDENDUM <No , December 22, 2009> This notification shall take effect from the date of notification.

15 < , > ADDENDUM <No , July 27, 2010> 1 ( ). 2 ( ) ( ). Article 1 (Effective Date) This Notification shall take effect from the date of notification. Article 2 (Interim Measures) A product manufacture (import) notification for Medical Devices or an application for obtaining an amended product license for Medical Devices, to the extent that such notification or application was already filed as of the effective date hereof, shall be as specified in the previous provisions.