(SCI, ).,,,. 3 ( ) ( ). 1. literature, etc.) for the Medical Device which has already been licensed (approved) or notified, whose technical characteri

Transcription

1 1 1 ( ) ( ). 1. " ". 2. " ",. 3. " ",. 4. " ". 5. " ",. 6. " ". Chapter 1 General Provisions Article 1 (Purpose) The purpose of these Regulations is to specify details necessary for review of technical documents, etc. for Medical Devices as provided in Paragraph 7 of Article 6 of the Medical Device Act and Paragraph 5 of Article 5 and Paragraph 4 of Article 7 of the Enforcement Regulations of the Medical Device Act. Article 2 (Definition) The definitions of the terms used herein are as follows: 1. "Components" mean parts necessary to construct the main body of the Medical Device. 2. "Test Specification" means test items, test standards and test methods, which are established for safety and performance validation of the product. 3. "New Structure" means essentially different form, raw material or principle of action from those of the Medical Devices which have already been licensed (approved) or notified. 4. "New Performance" means essentially different physiochemical functions from those of the Medical Devices which have already been licensed (approved) or notified. 5. "New Purpose of Use" means essentially different indications, efficacy and effectiveness, etc. from those of the Medical Devices which have already been licensed (approved) or notified. 6. "Newly Developed Medical Devices" mean Medical Devices to which both the New Structure and New Performance are applied. 7. " " 7. "Clinical Data" means Data regarding clinical trial records (SCI papers,

2 (SCI, ).,,,. 3 ( ) ( ). 1. literature, etc.) for the Medical Device which has already been licensed (approved) or notified, whose technical characteristics including raw material, structure, performance, and purpose of use are identical to those of the Medical Device requested for review, except that in the case of electrically-driven Medical Devices, raw materials, electrical network diagram, software, etc. may be different in part. Article 3 (Subject of Review, Etc.) The subject of review of data regarding technical documents shall be Medical Devices for which product manufacture or product import license (including amended license) is intended to be obtained. For Medical Devices falling under one of the followings from among the Medical Devices of the above Paragraph 1, Data regarding safety and efficacy shall be included in the review: Medical Devices falling under New Structure; Medical Devices falling under New Performance; Medical Devices falling under New Purpose of Use; Newly Developed Medical Devices; 5. 1 " " ( ) ( ) ( " " ) ( " ".) 7 2 ( " " ) ( ), ( ) 5. Medical Devices having a serious influence on the safety and efficacy of the product, whose "Major Technical Characteristics" mentioned in Attached Table 1 are wholly or partially different from the Medical Devices that have already been licensed (approved) or notified (also including change); and 6. Medical Devices for which the license conditions are changed from export to domestic sale, to the extent that such Medical Devices fall under Items 1 through 5 above. Article 4 (Scope of Review) When the KFDA Commissioner (hereafter the "Commissioner") received a Request for Review of technical documents, etc. for a Medical Device (hereafter a "Request for Review") as provided in Paragraph 2 of Article 7 of the Enforcement Regulations of the Medical Device

3 ,.,. 5 ( ), (KS) (IEC ISO )..,. 2 6 ( ) (CD ). 7 ( ) 6. Act (hereafter the "Enforcement Regulations"), a separate review shall be conducted with respect to each manufacturer (importer) of the product and each product item (model) thereof, in principle, and any product added after a Request for Review is received shall be excluded from review; provided, however, that the Same Product Group can be reviewed with one technical document. Article 5 (Generals) Terms, indication, symbol, etc., which are used in a Request for Review, in principle, shall be in compliance with the Korean Industrial Standards (KS) and international standards (IEC, ISO, etc.). A sample, which was submitted together with a Request for Review, shall not be returned, except that upon a demand by the test requestor for return of a sample, the sample shall be returned to the extent that such sample is still usable. Chapter 2 Review Data Article 6 (Application for Review of Technical Documents, Etc.) The party who desires to have technical documents, etc. reviewed for a Medical Device under Article 7 of the Enforcement Regulations shall submit, to the Commissioner, a copy of the Request for Review as per Attached Form No. 7 of the Enforcement Regulations, and attached materials, etc. specified in Paragraph 2 of Article 7 of the Enforcement Regulations, together with electronic recording media (e.g. CD, diskette, etc.) made using a dedicated program as specified by the Commissioner. Article 7 (Requirements for Attached Data) The requirements to be satisfied for attached data required to apply for a review of technical documents, etc. for Medical Devices under Article 6 are as follows: Data regarding review of technical documents. A. Data regarding purpose of use,,, Data regarding principle of action, indications, efficacy and effectiveness, purpose of use, etc. of the product

4 . B. Data regarding physiochemical properties 1) 2),,,,,,,,,, 3),,,,, 1) Physiochemical properties of the part of the Medical Device which is to contact the human body or to be put into the human body, or to contact blood, fluid or drug, etc. injected into the human body 2) In the case of Medical Devices using dental materials or polymer materials, etc., data regarding physiochemical properties and safety including the chemical structure of the raw materials, infrared absorption, UV absorption, atomic absorption, melting point, boiling point, durability, hardness, color, elute, surface properties, etc. and 3) In the case of a Medical Device whose end product contains animal-derived ingredients or animal-derived ingredients are used during production, data regarding animal name, country of origin, age, part of use, process, ingredient name, etc.. C. Data regarding electromechanical safety 1) ( ) (IEC, ISO ),,,,,, 2),,,,. D. Data regarding biological safety ( ) 1) In the case of electrically-driven Medical Devices, data regarding test items, test method, test conditions, reference values, test results, test facilities, test manager, etc. as provided in the Common Standards and Specifications for Electromechanical Safety of Medical Devices (KFDA Notification) and separately established standards and specifications for each item, or equivalent or higher international standards (IEC, ISO, etc.) 2) In the case of products equipped with software or software for independent use, data including model or name, version, algorithm or structure, major function and function display, operating environment, etc. of the software. In the case of a Medical Device or its component(s), which is to contact the human body or to be put into the body, or to contact blood, fluid or drug, etc. injected into the human body, data regarding test items, test method, test

5 (ISO, JIS, ASTM ),,,,,,.,.. E. Data regarding radiation safety, (IEC ),,,,,, conditions, reference values, test results, test facilities, test manager, etc. as provided in the Common Standards and Specifications for Electromechanical Safety of Medical Devices (KFDA Notification) and separately established standards and specifications for each item, or equivalent or higher international standards (IEC, ISO, etc.); provided that in the case of Medical Devices using raw materials with biological safety as notified by the Commissioner, it is not required to submit biological safety related data, as long as (i) the analysis certificate, etc. proving that the raw materials have been used, (ii) a raw material supply certificate, and (iii) manufacturing process-related data proving that simple mechanical processing has been done are attached. In the case of Medical Device using radiation or its Components requiring radiation safety of the Medical Device such as exposure to radiation, etc., data regarding test items, test method, test conditions, reference values, test results, test facilities, test manager, etc., as tests conducted under international standards (IEC, etc.) related with radiation safety. F. Data regarding electromagnetic interference (EMI) ( ) (IEC ) ( ). G. Data regarding performance,, ( ),, In the case of the Medical Device requiring safety against EMI or its Components, data regarding tests (including those additionally conducted for Medical Devices under international standards by separate items) as provided in the Common Standards and Specifications for Electromagnetic Safety of Medical Devices (KFDA Notification), or equivalent or higher international standards (IEC, etc.) Data regarding tests including preclinical performance test such as function intended by the product, performance, shelf life(available period), sterilization,

6 . 1) (KS, IEC, ISO, ASTM )., animal experiment, etc. H. One of the following data for Test Specification for confirmation of performance and safety of the product and the grounds for establishment, and actual measurement values 1) Domestic and foreign standards(ks, IEC, ISO, ASTM, etc.) necessary for validation of performance or safety, which is intended by the product; provided that if there is no specification, test specification and test method specified by the manufacturer, and the supporting data thereof 2) 3 2) Data regarding actual measurement values including the content mentioned in Attached Table 3 3) 3) Test Specification applied to the product for which the country of production and manufacturing site are the same, the raw material is the same as that of the product which has already been licensed (approved), and its performance is also identical, and the supporting data thereof Data regarding safety and efficacy review. A. Data regarding origin or grounds for discovery and development,,. B. Data regarding stability 1) ( ), 2) (,, ),,, Data which can demonstrate scientific appropriateness of the principle, use method, manufacturing method, etc. used to develop the product 1) Data regarding overview, storage method, setting of shelf life, etc., as test result of stability or durability (including matters of sequential changes in the sterilized material for a sterilized Medical Device) 2) Data regarding test conditions, measurement items, and preservation period on each test(long-term testing, accelerated test, stress test, etc.), as well as of test method, test result, etc.

7 . C. Data regarding results of clinical trial., 1. 1) 1) Generals,. ) A) Purpose of the clinical trial ) B) Institution and its address Data regarding testing for human beings in order to demonstrate safety and efficacy of the Medical Devices used for clinical trial; except that for items of Class 1 or 2, clinical data may instead be submitted. Data regarding clinical trial record for the Medical Device, issued by the director of the clinical trial institution approved by the Commissioner which conducted the clinical trial in accordance with the clinical trial plan approved by the Commissioner provided that such data shall include the followings: ),, C) Name and position of manager, supervisor, investigators, and co-investigators ) D) Test requestor and its address ),,,, E) Product name of the Medical Device subject to clinical trial, and the manufacturing number, form, performance, specification, etc. thereof ) F) Subject Diseases and indications ) G) Period of the clinical trial ) H) Method of the clinical trial (1), (1) Inclusion/exclusion criteria for subjects, the target number of subjects (2) (2) Operational method or instructions for use, and the grounds for establishment (3) (3) If the Medical Device for comparative testing is used, the reason for selection (4) (4) Combination therapy (5),,, (5) Observational items, measurement items, laboratory items, measurement criteria, and test method (6), ( ) (6) Performance evaluation criteria, evaluation method, and interpretation method

8 (statistics) (7) (7) Safety evaluation criteria including side effects and test method ) (,,,, ) ) J) Summary of case report I) Record of the clinical trial (The expected number of clinical cases, the actual number of subjects, the number of completed cases, the number of dropouts, and the reason shall be mentioned, and in this case, side effects by subjects, etc. shall be included.) ) K) Other data necessary for confirmation of clinical trial record 2) 2) The number of cases for the clinical trial 2,., (3) (3) Evaluation of effective ratio ( ). ( ) Data demonstrating that the number of cases for the clinical trial is decided in a statistically proper manner in comprehensive consideration of the characteristics of the Medical Device, clinical trial method, etc., such data being produced at two or more clinical trial institutions per indication, in principle; provided, however, that if it is difficult to actually secure the number of cases for the clinical trial due to few cases of the disease symptoms occurring, data capable of proving this shall be additionally attached. (A) Data demonstrating that the effective ratio of the Medical Device against the disease symptom has clinically statistical significance based on medical principles; if it is deemed appropriate, it can be recognized. (B) If deemed necessary by the Commissioner for evaluation of effective ratio, a request for review may be made to the Medical Device Committee.. D. Data regarding current status of foreign uses, etc.,,, Data regarding sale or licenses (approvals) in foreign countries, side effects reported at use, grounds for product manufacture license, etc., and if not used in the country of production, the reason therefore

9 ., , 3., 3. E. Data regarding comparative examination with domestic and foreign similar products and characteristics of the Medical Device Data regarding comparative examination with similar Medical Devices on structure, principle, purpose of use, use method, etc., as well as of performance and characteristics unique to the Medical Device differentiated from other existing Medical Devices Documentary evidence described in Sub-item C, Item 1, Paragraph 1 through Sub-item A to C, Item 2, Paragraph 1 shall fall under one of the followings, and among these, for test data, model and a list of raw materials shall be same as those of the product applied for review of technical documents, and it shall be in compliance with Attached Table 3; provided, however, that for test data, for which 3 years expired from the issue date as of the submission date, data demonstrating that there is no change in the product after the issue date shall be additionally submitted: Test data issued by the testing laboratory registered in the KFDA; 2. (IEC) (IECEE CB-Scheme) (NCB) 3. (OECD (GLP) GLP GLP 4. (Science Citation Index) 5. (,,, )., 2. Test data issued by the National Certification Body(NCB) under the IECEE CB-Scheme, which is run by the International Electrotechnical Commission(IEC); 3. Good Laboratory Practice(GLP) test data issued by an authorized GLP laboratory under GLP of the Organization for the Economic Cooperation and Development(OECD); 4. Data appearing in journals, which are registered in the Science Citation Index; 5. Data, which is issued by the director of the special agency and is deemed appropriate through examination of the content (including overview of testing facilities, major equipment, research personnel of the agency, investigator s experience, etc.) as tested at domestic and foreign special agencies including

10 colleges or research institutes, etc.; provided that unless there is internally or externally authorized test specification, data regarding safety and performance test on design and development of the product, which was performed under the manufacturer s quality management system; and 6. ( ) 8 ( ) ( ) Data (such as clinical trial results, etc.) submitted and evaluated as of the time of the license (approval) being obtained in the country where the Medical Device was developed, which data shall demonstrate that such data was received or approved by the government of such country or the registration authorities to which license (approval) affairs are delegated by such government. Article 8 (Exemption of Review Data) For Orphan Medical Devices, the attached data mentioned in Item 2 of Paragraph 1 of Article 7 herein shall not be required to be submitted. Chapter 3 Preparation of a Request for Review Article 9 (Preparation of a Request for Review) A Request for Review under the Attached Table 7 of the Enforcement Regulations shall be prepared as follows: 1. ( ). 1. In the Applicant field, the manufacturer (importer) and its representative shall be described 2. ( ) ( ),,.,. 3. ( )., In the Manufacturing (Importing) Company field, trade name (business name), business license number, and location shall be described, provided, however, that the space may be left blank if there is no business license number. 3. In the Manufacturer (in case of subcontracting of all import or manufacturing processes) field, both the manufacturer and the requestor for manufacture shall be described provided, however, that if the manufacturer is the same as the requestor for manufacture, only one of them may be described. 4. In the Type of Request for Review field, safety and efficacy review and technical documents review must be identified. Also, in the case of a review of

11 ,. amendment, safety and efficacy submission and technical documents submission must be identified and 5. In the Items Requested for Review field, each item shall be described and attached in compliance with the provisions of Articles 10 through 20 hereof. If some of the attached data set forth in Article 7 above is unnecessary in view of the characteristics of the product, the reason therefore shall be mentioned in detail. For foreign data, in principle, a Korean abstract containing a summary of major contents, and the original, shall be attached, and the whole translation of such data shall be required to be attached only to the extent necessary. 10 ( ). Article 10 (Product Name) For product name, classification name and model name shall be described as follows: 1.., For product name, if matters specified in the Regulations on Classifications of Medical Devices and Classes by product classifications as designated by the Commissioner are satisfied, the classification name, classification code, and class shall be described provided, however, that if the item name does not satisfy the Regulations on Items of Medical Devices and Class by Product, the Request for Review shall be filled in based on the result of examination as provided in Paragraph 5 of Article 3 of Regulations for Approval, etc. of Medical Device; For model name, the model name of the product subject to review shall be mentioned; and For a Combined Medical Device or a Complex Medical Device, the Request for Review shall be filled out for each of the component Medical Devices thereof in compliance with the provisions of the above Articles 1 and 2, based on the main purpose of use and superior grades of each of such component Medical Devices thereof.

12 11 ( ). 1. ( ),.,. 2.. Article 11 (Appearance, Structure and Dimensions) The form, structure, and dimensions shall be described as follows: 1. Appearance, structure, weight, dimensions, etc. shall be mentioned including the summary of the product (if the product is of liquid or powder type, the external feature shall be mentioned), and a clear- color picture shall be attached, which can identify the whole product and its Components; provided that the summary of the product shall include, among others, the principle applied for the development of the product. 2. For electromechanically-driven Medical Devices, the followings shall be mentioned:. A. Appearance, structure, weight, dimensions, and function of each part;. B. Principle of operation;. C. Electric rating;. D. Form and degree of protection against electric shock. E. Apparatus for Safety. F. Block diagram; and. (, ) (Isolation Diagram).,, G. Circuit diagram (power supply, mounting, etc.) or isolation diagram of the insulation, which can demonstrate electromechanical safety H. Structure or algorithm, and major function of the equipped software, with the exception of equipped software, which is not used for diagnosis, measurement, and analysis 3. For Combined Medical Devices and Composite Medical Devices, a list of Medical Devices shall be prepared, they shall be mentioned as provided in the above Item 1 or ( ) Article 12 (Raw Material or Ingredient and Quantity) The raw material or

13 . ingredient and quantity shall be mentioned as follows: Mentions for medical instruments or dental materials, etc... 일련 번호 명칭 원재료또는 성분및분량 규격 비고 ( 인체접촉여부 및접촉부위 ) A. Raw material, etc. shall be mentioned as shown in the following table: Serial No. Name Raw Material or Ingredient and Quantity Standard Remarks (Contact to the human body and the contact part)..... (KS, JIS, ASTM, IEC, ISO ),... B. In the Name field, name shall be mentioned for each of the Components and materials composing the Medical Device. C. In the Raw Material or Ingredient and Quantity field, generic name and chemical name of raw material, additives, or coloring agent, etc., which are used to compose the end product, Component or material, shall be mentioned. D. In the Standard field, as long as there is standard for the raw material, the standard (KS, JIS, ASTM, IEC, ISO, etc.) shall be mentioned, and if there is no standard, quantity and mixing ratio of ingredients, etc. shall also mentioned. E. If a drug is added, its name, ingredients, specification, and quantity shall be mentioned in compliance with the above Sub-item B or D, and the purpose of use of the drug shall be mentioned in the Remarks field Mentions for electrically or mechanically-driven devices, etc... 일련 번호 부분 품명 부분품관리번호 또는원재료명 규격수량비고 A. The raw material shall be mentioned as shown in the following table: Serial No. Compo nent Component Control No. or Raw Material Standard Quantity Remarks

14 .. B. In the Component field, generic name of the Component shall be mentioned (KS, JIS, ASTM, IEC, ISO ),. C. In the Component Control No. or Raw Material field, model or manufacturer control no., etc. for the Component shall be mentioned, and if the raw material is mentioned, Sub-item C of Item 1 shall be followed. D. In the Standard field, if there is standard for the Component, the standard (KS, JIS, ASTM, IEC, ISO, etc.) shall be mentioned; otherwise, characteristics including performance of the Component shall be mentioned... E. In the Quantity field, quantity of each Component shall be mentioned.., 1..,, ( ).,. F. For a Medical Device which is to contact the human body or to be inserted into the human body, or to contact blood, fluid or drug, etc. injected into the body, or to which a drug is added, the Request for Review shall be filled out in accordance with the provision of each sub-item of the above Item 1. G. If software is embedded in the Medical Device or is independently used, model or name, version, operating environment, etc. shall be mentioned as provided in Sub-item A. 3. For a Combined Medical Device or a Complex Medical Device, the Request for Review shall be completed as provided in the above Item 1 or 2 by individual Medical Devices. Article 13 (Manufacturing Method) The phrase The manufacturing method of the manufacturer is followed shall be described provided, however, that upon one of the followings, the relevant matter shall be additionally described : In the case of manufacturing method of sterilized Medical Devices, sterilizing method, sterilizing conditions, packing method, etc. and 2.,,,,, 2. In the case of a Medical Device whose end product contains animal-derived ingredients or uses animal-derived ingredients during production, data regarding animal name, country of origin, age, part of use, process, ingredient name, etc.

15 14 ( ). Article 14 (Performance and Purpose of Use) Performance and purpose of use shall be mentioned as follows: 1. ( ). 1. In the case of performance, functional characteristics and specification (performance) of the product shall be mentioned; 2.,. 3., ( ),,,.,. 16 ( ),. 17 ( ). 2. The purpose of use shall be mentioned based on documentary evidence of the disease symptoms, efficacy and effectiveness, or purpose of use which is intended by the manufacturer and 3. In the case of a Combined Medical Device, the Request for Review shall describe the performance and purpose of use as set forth in the above Items 1 and 2 for both each of the component Medical Devices thereof and such Combined Medical Device. In the case of a Composite Medical Device, the Request for Review shall describe, for each of the component Medical Devices thereof, the performance and purpose of use as set forth in the above Items 1 and 2. Article 15 (Operation Method or Instruction for Use) For operation method or use method, the Request for Review shall describe preparations before use, operation method, use method, keeping and control method after use. Specifically, if sterilization prior to use is required, the sterilizing conditions and method shall be exactly mentioned, and if software is embedded in the Medical Device or is independently used, the Request for Review shall accurately describe the method of using such function, together with a screen picture showing each function of the program. Article 16 (Packing Unit) For the packing unit of the Medical Device, the Request for Review shall describe theminimum unit easy to handle, and shall mention Internal Packing Unit in the case of manufacturing and Manufacturer s Packing Unit in the case of imports. Article 17 (Precautions for Use) The followings shall be mentioned with regard to

16 1. 2. precautions for use: 1. Indication of warning and age, gender, and physical condition for use in consideration of characteristics of the Medical Device; 2. Precautions for use by specialist s prescription, fatal side effects caused by careless use, and cautions against accident; Relevant cautions if necessary for prevention of negligent accident. 18 ( ). 1. ( ). 2. ( ) ( ) ,. 2. ( ) (IEC SO ),. 3., Article 18 (Storage Method or Shelf Life) The Request for Review shall describe storage method or shelf life, as follows: 1. For Medical Devices requiring control of specific storage or sterilization, etc. to maintain the quality of the product, the Request for Review shall describe storage method (storage conditions, etc.), so that safety can be secured. 2. If a shelf life(valid term) is specified, the Request for Review shall be completed based on the data verified under Sub-item B, Item 2, Paragraph 1, Article 7, or other recognized documentary evidence. Article 19 (Test Specification) Test Specification shall be mentioned as follows: 1. Based on the attachment specified in Article 7 herein, necessary test items shall be selected among the test items for Medical Devices as mentioned in Attached Table 2 according to the characteristics of the product, and relevant test standard and test method shall be mentioned; 2. If the Medical Device Standard Specification (KFDA Notification) or equivalent or higher international standards (IEC SO, etc.) are applied as Test Specification, the Request for Review shall describe the title, number and year of issue of the standards. The same is required when such specification or standards are applied partially. 3. The test standard shall clearly mention the permissible range of reference values, based on which acceptance/rejection of the test result is determined, and if

17 . 4.,, ( ) , ( ) the test result is influenced by surrounding conditions such as temperature, humidity, etc., the conditions shall be specified 4. The test method shall be mentioned in a specific and summarized manner so that the test result can be exactly calculated according to the sequence; 5. In the case of a Combined Medical Device or a Composite Medical Device, the Test Specification to be applied for the evaluation of the Combined Medical Device as a whole or the Composite Medical Device as a whole shall be established separately from the Test Specification to be applied for the evaluation of each of the component Medical Devices thereof. Article 20 (Labeling) Matters that are required to be mentioned in the container, packing, and attached document of each Medical Device shall be as provided in Articles 19 through 23 of the Act and Articles 26 through 28 of the Enforcement Regulations, and regarding matters of technical information including characteristics of the Medical Device as specified in Item 10, Paragraph 1, Article 27 of the Enforcement Regulations, only the details specified in Article 19 herein shall be mentioned; provided, however, that in the case of a Combined Medical Device or a Complex Medical Device, such matters shall be mentioned for each of the component Medical Devices thereof. Article 21 (Review in Respect of the Amendment of Technical Documents, etc.) The party who desires to have a review conducted in respect of the amendment of technical documents, etc. for the Medical Device, etc. as provided in Article 7 of the Enforcement Regulations shall submit a Request for Review as per Attached Form No. 7 of the Enforcement Regulations in compliance with the provisions of Articles 9 through 20 with respect to the amended items. In requesting a review in respect of the amendment under the above Paragraph 1, the following attached documents shall be submitted :

18 Each one (1) copy of history of documentation and a comparison table for changes One (1) copy of documentary evidence regarding changes, which forms part of the data specified in Article 7 herein; One (1) copy of notice of review result of technical documents, etc. for the Medical Device in the Attached Form No. 8 of the Enforcement Regulations,which has already been issued; and 4. 1 ( ) 4. One (1) copy of the product license (only for products forwhich such product license has been obtained) 일련기술문서품목허가주요변경내용번호문서번호일자문서번호일자 1 최초 2. 번호항목변경전변경후변경사유 Among documents mentioned in the above Item 2 of Paragraph 2, history of documentation and change comparison sheet shall be mentioned as shown in the following: 1. History of documentation Serial Technical Documents Product License Major No. Document No. Date Document No. Date Amendment 1 Initial 2. Change Comparison Sheet No. Item Before change After change Reason for change 4 Chapter 4 Supplementary Provisions 22 ( ) Article 22 (Data Supplementation) If, during a review of technical documents

19 7. or other data under Article 7 of the Enforcement Regulations, data fall under one of the followings, the Commissioner or the director of the technical document review agency designated by the Commissioner may, by specifically stating the necessary measures, demand the applicant for review to supplement such data : If the details described in the Request for Review do not comply with the above Chapter 3; 2., , ,.. 2. If the kind or scope of attached data or requirements with respect to attached data do not comply with the provisions of Articles 6 and 7 herein; or 3. If it is deemed that additional data, etc. are necessary to ensure the appropriateness of the review, in addition to Item 1 or 2 above. Data supplementation mentioned in the above Paragraph 1, in principle, shall be limited to one (1) time, and the supplementary period shall be 30 days. If the data required to be supplemented during such period is not submitted, the review applicant may be requested again to supplement the data with 10 days; provided, however, that if the applicant makes a request for extension of time by specifying the period for supplementation, the period to be given to the review applicant may be decided in consideration of such request. If safety and efficacy are not recognized as falling under one of the followings during, or as a result of, review, the Commissioner or the director of the technical document review agency designated by the Commissioner may reject the supplementation of data by specifying the grounds for such rejection to the applicant for review: If data are not submitted in the request period specified in the above Paragraph 2; If the Request for Review remains unsuitable for the above Chapter 3, despite supplementation made under the above Paragraph 1; or

20 3., ( ).. 24 ( ) ( 248 ), ( ). 3. If the kind or scope of attached data or requirements with respect to attached data do not comply with the provisions of Articles 6 and 7 herein; and Article 23 (Advice, Etc.) The Commissioner may get advice from the Medical Device Committee and the Medical Device Safety and Efficacy Review Council, if necessary for review of technical documents, etc. for Medical Devices, etc. The Commissioner of KFDA can issue a technical guide for relevant evaluation to ensure the appropriateness of the review of newly developed Medical Devices. Article 24 (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 for taking measures of abolition, amendment, etc. of this Notification through examination of legal or current conditions after issuing this notification shall be by June 3, < > ADDENDUM <March 2, 2005> ( ) ( ) ( ). ( ). (Effective Date) This notification shall take effect from the date of notification. (Nullification of Other Notifications) At the same time with enforcement of the Regulations, the Regulations on Review of the Criteria for Medical Instruments and Testing Method(KFDA Notification No ) and the Regulations on Review of Medical Instruments Safety and Efficacy(KFDA Notification No ) shall be nullified. < > ADDENDUM <October 24, 2005> ( ). (Effective Date) This notification shall take effect from the date of notification. (Interim Measures) Technical documents, which, as of the effective date hereof, were requested for review under the existing Regulations on Review of Technical Documents, Etc. of Medical Devices, shall be reviewed under the existing notification and regulations. < > ADDENDUM <May 17, 2006>

21 ( ). (Effective Date) This notification shall take effect from the date of notification. < > ADDENDUM <January 10, 2007> ( ) (2) , " ". (Effective Date) This Notification shall take effect from the date of notification; provided that sub-item C-(2), Item 1, Article 7 herein shall take effect from October 1, 2007, and matters of electromagnetic susceptibility in sub-item F shall be enforced under the "Common Standards and Specifications on Electromagnetic Safety of Medical Devices", which is to be separately enacted and notified. < > ADDENDUM <July 20, 2007> ( ). 3 2 " " ( )... (Effective Date) This notification shall take effect from the date of notification, with the exception that "Clinical Data" mentioned in Paragraph 2 of Article 3 herein shall take effect from January 1, < > ADDENDUM <January 31, 2008> (Effective Date) This notification shall take effect from the date of notification. < > ADDENDUM <October 30, 2009> This notification shall take effect from the date of notification. < > ADDENDUM <December 30, 2009> This notification shall take effect from the date of notification. < > ADDENDUM <June 11, 2010> 1 ( ). 2 ( ) ( ),. Article 1(Effective Date) This notification shall take effect from the date of notification. Article 2 (Applicable Examples) An application for product manufacture (import) license, an application for amended license, or a Request for Review of technical documents, etc. for Medical Devices, etc., which has already been received as of the effective date hereof, shall be subject to this Notification.