ENFORCEMENT DECREE OF THE ACT ON NURTURING MEDICAL DEVICES INDUSTRY AND SUPPORTING INNOVATIVE MEDICAL DEVICES

Article 1(Purpose) #

The purpose of this Decree is to provide for matters delegated by the Act on Nurturing Medical Devices Industry and Supporting Innovative Medical Devices and matters necessary for the enforcement thereof.

Article 2(Amounts of Research and Development Cost of Innovative Medical Devices Company) #

(1) "Amount defined by Presidential Decree" in subparagraph 3a and b of Article 2 of the Act on Nurturing Medical Devices Industry and Supporting Innovative Medical Devices (hereinafter referred to as the "Act") means the following amounts of annual research and development expenses of medical devices:

1. A medical device company whose annual sales of medical devices are at least 50 billion won: An amount equivalent to 6/100 of the annual sales of medical devices;

2. A medical device company whose annual sales of medical devices are less than 50 billion won: An amount equivalent to 8/100 of the annual sales of medical devices or three billion won.

(2) Annual research and development expenses of medical devices and annual sales of medical devices under paragraph (1) mean the annual average of research and development expenses of medical devices and sales of medical devices in the business year for the three years immediately preceding the business year in which an application for the certification of an innovative medical device company is filed pursuant to Article 10(1) of the Act. In such cases, where the immediately preceding business year is less than three years, it means the annual average of research and development expenses of medical devices and sales of medical devices from the commencement date of the business to the end of business year immediately preceding the business year in which an application for the certification is filed.

(3) Standards for calculating research and development expenses of medical devices, the details thereof, and standards for calculating sales of medical devices under paragraph (1) shall be determined and publicly notified by the Minister of Health and Welfare.

Article 3(Establishment of Implementation Plan) #

(1) The head of the relevant central administrative agency shall submit an implementation plan for the following year to the Minister of Health and Welfare by June 30 of each year pursuant to Article 7(2) of the Act.

(2) The Minister of Health and Welfare shall integrate and review the implementation plan for the following year for each institution submitted pursuant to paragraph (1), and formulate an implementation plan for the following year after deliberation by Medical Devices Industry Promotion and Support Committee (hereinafter referred to as the "Committee") under Article 8(1) of the Act.

(3) The Minister of Health and Welfare shall notify the head of the relevant central administrative agency of an implementation plan for the following year formulated pursuant to paragraph (2) by December 31 of each year.

(4) The head of the relevant central administrative agency shall submit the achievements of the implementation plan for the preceding year by March 31 of each year pursuant to Article 7(2) of the Act.

(5) Where the Minister of Health and Welfare evaluates the achievements based on the implementation plan for the preceding year pursuant to Article 7(3) of the Act, he or she shall undergo deliberation by the Committee.

(6) The head of the relevant central administrative agency shall reflect the results of evaluation notified pursuant to Article 7(3) of the Act in formulating an implementation plan for the following year, except in extenuating circumstances.

Article 4(Functions and Composition of Committee) #

(1) "Others ... defined by Presidential Decree" in Article 8(1)4 of the Act means the following matters:

1. Matters regarding the evaluation of the achievements of the implementation plan for the preceding year;

2. Other matters that the chairperson of the Committee refers to deliberation on the medical devices industry promotion and support.

(2) "Relevant central administrative agency prescribed by Presidential Decree" in Article 8(3)1 of the Act means the following central administrative agencies: <Amended on Oct. 1, 2025; Dec. 30, 2025>

1. Ministry of Finance and Economy;

2. Ministry of Science and ICT;

3. Ministry of Trade, Industry and Resources;

4. Other central administrative agencies deemed necessary by the chairperson of the Committee to deliberate on the matters prescribed in Article 8(1) of the Act.

(3) The term of office of an appointed member (hereinafter referred to as "appointed member") prescribed in Article 8(3)2 of the Act shall be two years and he or she may be consecutively renewed only once.

(4) Where an appointed member falls under any of following subparagraphs, the chairperson of the Committee may dismiss such member:

1. Where he or she becomes incapable of performing his or her duties due to mental or physical disability;

2. Where he or she commits any wrongdoing related to his or her duties;

3. Where he or she is deemed unsuitable for a member due to delinquency of duties, injury to dignity, or any other reason;

4. Where he or she fails to refrain despite the fact that he or she falls under any ground prescribed in Article 8(4) or (5) of the Act;

5. Where he or she voluntarily declares that it is impracticable to perform his or her duties.

Article 5(Operation of Committee) #

(1) The chairperson of the Committee shall represent the committee and exercise general supervision over its affairs.

(2) Where the chairperson of the Committee fails to perform his or her duties due to any extenuating circumstances, the member predesignated by the chairperson of the Committee shall act on his or her behalf.

(3) Where requested by at least 1/3 of all incumbent members or where deemed necessary by the chairperson of the Committee, the chairperson of the Committee shall convene and preside over the meetings of the Committee.

(4) A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of at least a majority of those present; provided, where the contents of an agenda item are minor or where there is no sufficient time to convene a meeting, the Committee may resolve on the agenda item in writing.

(5) Appointed members who attend the meetings of the Committee may be paid allowances, and reimbursed travel expenses and other necessary expenses within the budget.

(6) Except as provided in paragraphs (1) through (5), matters necessary for the operation of the Committee shall be determined by the chairperson of the Committee after resolution by the Committee thereon.

Article 6(Functions, Composition and Operation of Working-Level Committee) #

(1) A working-level committee shall be established under the Committee pursuant to Article 8(7) of the Act to deliberate on matters deemed necessary for prior examination among the matters set forth in the subparagraphs of Article 8(1) of the Act and requested by the chairperson of the Committee.

(2) The working-level committee shall be comprised of up to 15 persons, including one chairperson, with due consideration given to gender composition.

(3) The chairperson of the working-level committee shall be appointed by the chairperson of the Committee, from among public officials belonging to the Senior Executive Service of the Ministry of Health and Welfare in charge of policies on the health industry, and members of the working-level committee shall be commissioned by the chairperson of the Committee from among any of the following persons:

1. Persons recommended by the heads of the relevant central administrative agencies, from among public officials belonging to the Senior Executive Service of the relevant central administrative agencies to which ex officio members under Article 8(3)1 of the Act belong;

2. Persons who have much knowledge and experience in the medical devices industry, who are engaged in industrial circles, academic circles, etc.

(4) Where the chairperson of the working-level committee fails to perform his or her duties due to unavoidable circumstances, the member designated in advance by the chairperson of the working-level committee shall act on his or her behalf.

(5) The working-level committee shall have two secretaries, and each of whom shall be appointed respectively by the Minister of Health and Welfare and the Minister of Food and Drug Safety from among public officials belonging to the Ministry of Health and Welfare and the Ministry of Food and Drug Safety.

(6) In order to perform the duties of the working-level committee in an efficient manner, subcommittees by field may be established in the working-level committee.

(7) Except as provided in paragraphs (1) through (6), matters necessary for the composition and operation of the working-level committee and subcommittees by field and other matters shall be determined by the chairperson of the working-level committee, following a resolution by the working-level committee.

Article 7(Research Fellows) #

(1) The Committee may have up to 10 research fellows to professionally survey and research the matters specified in each subparagraph of Article 8(1) of the Act.

(2) The chairperson of the Committee shall commission research fellows under paragraph (1) from among persons who have much knowledge and experience in the medical devices industry.

(3) Research fellows under paragraph (1) may attend and speak at meetings of the Committee or the working-level committee.

Article 8(Scope and Method of Survey on Actual Situation) #

(1) The scope of a survey on actual situation under Article 9(1) of the Act shall be as follows:

1. Regulatory trends in the domestic and overseas medical device industry;

2. Market size and the current status of exports and imports of the domestic and overseas medical device industry;

3. Status of investment in the domestic and overseas medical device industry;

4. Technological competitiveness of domestic medical devices;

5. Status of use of domestic medical devices;

6. Current status of research and development of domestic medical devices;

7. Current status of the demand for and supply of human resources for the domestic medical device industry;

8. Other matters deemed necessary by the Minister of Health and Welfare to conduct a survey.

(2) The Minister of Health and Welfare may conduct a survey on actual situation under Article 9(1) of the Act by means, such as in writing, by telephone or e-mail.

(3) Where the Minister of Health and Welfare intends to conduct a survey on actual situation pursuant to Article 9(1) of the Act, he or she shall inform persons subject to the survey on actual situation of the date, purpose, details, etc. thereof in advance.

Article 9(Certification Standards for Innovative Medical Devices Companies) #

The certification standards for innovative medical devices companies under the latter part of Article 10(2) of the Act shall be as follows:

1. Whether the companies have personnel or organizations dedicated to the research and development of medical devices;

2. Investment records of research and development of medical devices;

3. Objectives and mid- to long-term strategies for research and development of medical devices;

4. Records of overseas cooperative activities related to research and development of medical devices;

5. Results of obtaining domestic and overseas authorization and permission concerning the results of research and development of medical devices;

6. Level of contribution to the improvement of public health through research and development, and distribution of excellent medical devices;

7. Whether the distribution system and order of sales of medical devices are observed;

8. Other standards deemed necessary and publicly notified by the Minister of Health and Welfare as certification standards.

Article 10(Requirements for Exceptions to Deliberation on Succession to Status) #

"Requirements defined by Presidential Decree" in Article 11(2)2 of the Act means any of the following requirements:

1. Where an innovative medical devices company acquires or merges with another medical devices company and a corporation surviving or newly incorporated after such acquisition or merger intends to succeed to the status of the innovative medical devices company, the business of the innovative medical devices company shall be maintained in whole;

2. Where a company intends to succeed to the status of an innovative medical devices company due to any of the following changes in relation to the innovative medical devices company, the business of the innovative medical devices company shall be maintained in whole:

a. Name of a company;

b. Representative;

c. Registered Director;

d. Corporation registration number;

e. A person who actually controls an innovative medical devices company (referring to a person who holds at least 50/100 of the total number of issued stocks or total amount of investment or exercises a dominant influence over major decision making).

Article 11(Cancellation of Certification) #

(1) Where the Minister of Health and Welfare cancels the certification of an innovative medical devices company pursuant to Article 13(1) of the Act, he or she shall notify such fact to the person who has received such certification, the head of a relevant central administrative agency, and the head of the relevant local government without delay, and publish such fact in the website of the Ministry of Health and Welfare.

(2) Where the head of the relevant central administrative agency and the head of the relevant local government have suspended preferential treatment and have taken measures to return benefits pursuant to Article 13(3) and (4) of the Act, they shall notify the Minister of Health and Welfare of such fact without delay.

Article 12(Classification of Innovative Medical Devices Companies by Type) #

Classification of an innovative medical devices company by type under Article 15(1) of the Act are as follows:

1. Leading innovative medical devices company: A medical devices company with annual sales of medical devices at least 50 billion won, which has invested at least 6/100 of annual sales of medical devices in research and development expenses for medical devices among the medical devices companies falling under items of subparagraph 3 of Article 2 of the Act;

2. Leaping innovative medical devices company: Any of the following companies:

a. A medical devices company with annual sales of medical devices less than 50 billion won, which has invested at least 8/100 of annual sales of medical devices or 3 billion won in research and development expenses for medical devices among the medical devices companies falling under subparagraph 3a or b of Article 2 of the Act;

b. An innovative medical devices company under subparagraph 3c of Article 2 of the Act (excluding cases falling under subparagraph 1).

Article 13(Special Cases in Construction of Research Facilities) #

(1) "Facilities such as prototype production facilities and other facilities recognized for an auxiliary purpose as stipulated in Presidential Decree" in Article 18(1) of the Act means the following facilities:

1. Prototype production facilities; provided, prototype production facilities intending to commercialize and sell the outcomes of research and development shall be excluded;

2. Other research facilities or facilities for auxiliary purpose to enhance the utilization of the outcomes of research and development, which are determined and publicly notified by the Minister of Health and Welfare.

(2) "Areas prescribed by Presidential Decree such as green area" in Article 18(1) of the Act means the following areas:

1. Exclusive residential areas under Article 36(1)1 of the National Land Planning and Utilization Act and Article 30(1)1a of the Enforcement Decree of the same Act; Class I general residential areas under item b, i of the same subparagraph; green conservation areas under subparagraph 4a of the same paragraph; and green production areas under item b of the same item;

2. Conservation control areas under Article 36(1)2a of the National Land Planning and Utilization Act; production control areas under item b of the same subparagraph; agricultural and forest areas under subparagraph 3 of the same paragraph; and natural environment conservation areas under subparagraph 4 of the same paragraph.

(3) Public notice under Article 18(1) of the Act shall include the following matters:

1. The name, location and size of the relevant area;

2. A topographic map indicating the relevant area on a scale of at least 1:25,000.

Article 14(Designation of Innovative Medical Devices Group) #

(1) The Minister of Health and Welfare may survey demand for the designation of an innovative medical devices group under Article 20(1) of the Act (hereinafter referred to as "innovative medical devices group") among institutions and organizations in the medical device industry, persons engaged in industrial circles, academic circles, etc., and may notify the Commission of the results thereof.

(2) Details necessary for the survey under paragraph (1) shall be determined and publicly notified by the Minister of Health and Welfare.

(3) The Minister of Health and Welfare may designate an innovative medical devices group by the following fields following deliberation by the Committee pursuant to Article 20(1) of the Act:

1. A field to which advanced technology with high technological intensity and fast innovation is applied;

2. A field of which safety and effectiveness have been significantly improved or are expected to be improved;

3. A field in which development of critical technologies applied to medical devices is urgently needed;

4. A field in which there is no substitute for medical devices used for the diagnosis and treatment of a rare or incurable disease or in which there is difficulty in the domestic supply of and demand for such medical devices;

5. Other fields deemed necessary by the Minister of Health and Welfare to be designated.

(4) The Minister of Health and Welfare may designate an innovative medical devices group and conduct re-assessment thereof under Article 20(1) and (2) of the Act in consideration of the following matters:

1. Whether critical technologies applied to medical devices has already been widely used;

2. Other matters deemed necessary by the Minister of Health and Welfare to be considered.

Article 15(Designation of Innovative Medical Devices) #

(1) A person who intends to obtain the designation of innovative medical devices pursuant to Article 21(1) of the Act shall file an application for the designation of innovative medical devices (including an application in electronic form) with the Minister of Food and Drug Safety, along with the following data (including electronic documents):

1. Data on the details of development;

2. Data on the purpose of use;

3. Data on the operating principle;

4. Data on the methods of use;

5. Data on the performance;

6. Data on the current status of the use of domestic and overseas similar products;

7. Summary verifying that a product falls under an innovative medical device.

(2) Upon receipt of an application for designation of innovative medical devices pursuant to paragraph (1), the Minister of Food and Drug Safety shall send the data in the subparagraphs of paragraph (1) to the Minister of Health and Welfare without delay for consultation on the designation of the innovative medical devices under the latter part of Article 21(2) of the Act.

(3) Where deemed necessary for the designation of innovative medical devices under Article 21 (2) of the Act, the Minister of Food and Drug Safety may request the institutions, organizations, experts, etc. related to innovative medical devices to present opinions or data.

(4) Where the Minister of Food and Drug Safety has designated innovative medical devices pursuant to Article 21(2) of the Act, he or she shall issue a certificate of designation of innovative medical devices to an applicant.

(5) Except as provided in paragraphs (1) through (4), details necessary for the procedures for, methods of, and consultation on the designation of the innovative medical devices shall be determined and publicly notified by the Minister of Food and Drug Safety.

Article 16(Cancellation of Designation of Innovative Medical Devices) #

(1) Where the Minister of Food and Drug Safety intends to cancel the designation of innovative medical devices pursuant to the main clause, with the exception of the subparagraphs, of Article 21(5) of the Act, he or she shall forward data, etc. verifying that the relevant innovative medical device falls under any of Article 21(5) 2 through 4 of the Act to the Minister of Health and Welfare for consultation on the cancellation thereof.

(2) Where the Minister of Food and Drug Safety cancels the designation of innovative medical devices pursuant to Article 21(5) of the Act, he or she shall notify the Minister of Health and Welfare of the cancellation thereof and publish the details thereof in the website of the Ministry of Food and Drug Safety.

(3) A person whose designation of innovative medical devices has been canceled pursuant to Article 21(5) of the Act shall return a certificate of designation of innovative medical devices to the Minister of Food and Drug Safety without delay. In such cases, if the certificate of designation of innovative medical devices is lost, a statement explaining the reasons therefor shall be submitted.

(4) Except as provided in paragraphs (1) through (3), details necessary for the procedures for, methods of, and consultation on the cancellation of designation of the innovative medical devices shall be determined and publicly notified by the Minister of Food and Drug Safety.

Article 17(Designation of Information Management Institutions Related to Research and Development) #

(1) In accordance with Article 26(2) of the Act, the Minister of Health and Welfare and the Minister of Food and Drug Safety may designate institutions dedicated to the management of information on research and development of innovative medical devices that satisfy all of the following requirements. In such cases, the relevant institution may be designated for each field of information on research and development of innovative medical devices:

1. It shall be a public institution under Article 4 of the Act on the Management of Public Institutions or non-profit corporation;

2. It shall have personnel and equipment deemed necessary for the professional management of information on research and development of innovative medical devices and publicly notified by the Minister of Health and Welfare or the Minister of Food and Drug Safety.

(2) Where the Minister of Health and Welfare or the Minister of Food and Drug Safety designates institutions pursuant to Article 26(2) of the Act, he or she shall publish the following matters in the website of the Ministry of Health and Welfare or the Ministry of Food and Drug Safety:

1. The name and address of the relevant institution and name of the representative thereof;

2. The field of information on research and development of innovative medical devices managed by the relevant institution;

Article 18(Rewards for Medical Devices Companies) #

(1) Kinds of rewards under Article 27(1) of the Act shall be as follows:

1. The grand prize for innovative medical devices companies;

2. The excellence prize for innovative medical devices companies in each category;

3. The special prize for innovative medical devices companies.

(2) The Minister of Health and Welfare may subsidize a person who receives a reward under Article 27(1) of the Act for research and development expenses of medical devices, training expenses, etc.

(3) The Minister of Health and Welfare shall annually determine and publicly announce the standards for granting rewards, methods and procedures for selecting winners, and other relevant matters.

Article 19(Designation of Professional Development Organizations) #

(1) Standards for designating a professional development organization under Article 31(2) of the Act (hereinafter referred to as "professional development organization") shall be as follows:

1. It shall be any of the following institutions:

a. A school under Article 2 of the Higher Education Act;

b. A public institution under Article 4 of the Act on the Management of Public Institutions that performs affairs related to medical devices industry;

c. A corporation under Article 32 of the Civil Act or the Act on the Establishment and Operation of Public Interest Corporations that perform affairs related to medical devices industry;

2. It shall have facilities and personnel deemed necessary to nurture professionals and publicly notified by the Minister of Health and Welfare or the Minister of Food and Drug Safety.

(2) A person who intends to obtain the designation of a professional development organization shall file an application for the designation of a professional development organization (including an application in electronic form) with the Minister of Health and Welfare or the Minister of Food and Drug Safety along with the following documents (including electronic documents):

1. The status of facilities and personnel necessary for nurturing professionals;

2. A business plan for nurturing professionals;

3. Operating regulations on the nurturing courses for professionals;

4. Other documents deemed necessary by the Minister of Health and Welfare or the Minister of Food and Drug Safety for designating a professional development organization.

(3) Upon receipt of an application under paragraph (2), the Minister of Health and Welfare or the Minister of Food and Drug Safety shall verify the corporation registration certificate of the applicant (limited to where the applicant is a corporation) through administrative data matching under Article 36(1) of the Electronic Government Act.

(4) Where the Minister of Health and Welfare or the Minister of Food and Drug Safety designates a professional development organization, he or she shall issue a certificate of the designation of a professional development organization.

(5) Where the Minister of Health and Welfare or the Minister of Food and Drug Safety designates, or cancels the designation of, a professional development organization pursuant to Article 31(2) or (3) of the Act, he or she shall publish such fact in the website of the Ministry of Health and Welfare or the Ministry of Food and Drug Safety.

Article 20(Designation and Operation of Comprehensive Support Centers for Medical Devices Industry) #

(1) The Minister of Health and Welfare shall designate the Korea Health Industry Development Institute under the Korea Health Industry Development Institute Act as a comprehensive support center for the medical devices industry pursuant to Article 33(1) of the Act.

(2) To provide support under Article 33(1) of the Act, a comprehensive support center for the medical devices industry shall be equipped with necessary facilities and equipment, such as an online affair handling system, and shall have at least one department dedicated to the comprehensive support center for the medical devices industry and at least six personnel dedicated thereto (referring to persons who have at least three years’ experience in the field related to medical devices).

(3) "Other business affairs ... prescribed by Presidential Decree" in Article 33(1)5 of the Act means support affairs necessary for the designation and reassessment of an innovative medical devices group under Article 20(1) and (2) of the Act.

(4) The head of a comprehensive support center for the medical devices industry shall submit a business plan, a budget bill, and the settlement of accounts to the Minister of Health and Welfare and report the business performance by the date specified in each of the following pursuant to Article 33(2) of the Act:

1. A business plan and a budget bill: December 31 of the immediately preceding business year;

2. The settlement of accounts and business performance: January 31 of the following business year.

Article 21(Support for Export) #

The Government and local governments may provide support to individuals or organizations which promote medical devices or explore the overseas market for medical devices produced by medical devices companies under subparagraph 2a of Article 2 of the Act pursuant to Article 34 of the Act:

1. Participation in international specialized academic societies and overseas exhibitions related to health and medical services;

2. Acquisition of authorization and permission from the country to export;

3. Provision of specialized information for entry into overseas markets;

4. Establishment of a sales and distribution system necessary for export;

5. Other matters deemed necessary by the Government and local governments for overseas promotion and exploration of overseas markets.

Article 22(Criteria for Imposing Penalty Surcharge) #

The criteria for imposing penalty surcharges under Article 38(1) of the Act shall be as specified in Appendix 1.

Article 23(Delegation or Entrustment of Authority or Business Affairs) #

(1) The Minister of Health and Welfare may entrust the following affairs to the Korea Health Industry Development Institute under the Korea Health Industry Development Institute Act pursuant to Article 41(2) of the Act:

1. A survey on actual situation under Article 9(1) of the Act;

2. Support for clinical trials of medical devices under Article 28(1) of the Act;

3. Support for the promotion of use of innovative medical devices, etc. under Article 30 of the Act;

4. Support for the export under Article 34 of the Act;

5. Support for the international cooperation under Article 35(1) of the Act.

(2) The Minister of Food and Drug Safety may delegate the following authority to the heads of the regional offices of food and drug safety pursuant to Article 41(3) of the Act:

1. The following authority under Article 36 of the Act:

a. Investigation of the manufacturing, import, use, etc. of innovative medical devices under Article 36(1) of the Act;

b. Request for provision of documents or opinion under the former part of Article 36(2) of the Act;

c. Orders for actions on safety use of innovative medical devices under Article 36(3) of the Act;

2. Revoking manufacturing permission, import permission, manufacturing certification, or import certification (hereinafter referred to as "manufacturing permission, etc."), and issuing orders to suspend manufacturing, import, or sales of innovative medical devices under Article 37(1) of the Act;

3. Imposing and collecting penalty surcharges under Article 38 of the Act;

4. Holding hearings under Article 40(2) of the Act.

(3) The Minister of Food and Drug Safety shall entrust the following affairs to the National Institute of Medical Device Safety Information under Article 42 of the Medical Devices Act pursuant to Article 41(4) of the Act:

1. Support for clinical trials of innovation medical devices under Article 28 (2) of the Act;

2. Promotion of projects to secure the safety and effectiveness of innovative medical devices under Article 29(1) of the Act.

Article 24(Processing of Personally Identifiable Information) #

The Minister of Food and Drug Safety (including the heads of the regional offices of food and drug safety to whom the authority of the Minister of Food and Drug Safety is delegated pursuant to Article 23(2)) may handle materials including resident registration numbers and alien registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of the Personal Information Protection Act, if inevitable to conduct the following administrative affairs:

1. Affairs concerning the designation of innovative medical devices and cancellation of such designation, etc. under Article 21 of the Act;

2. Affairs concerning phase-specific reviews, preferential reviews, etc. of innovative medical devices under Article 22 of the Act;

3. Affairs concerning the cancellation of manufacturing permission, etc. and orders to suspend manufacturing, import and sale of innovative medical devices under Article 37 of the Act;

4. Affairs concerning the imposition and collection of a penalty surcharge under Article 38 of the Act;

5. Affairs concerning hearings under Article 40(2) of the Act.

Article 25(Criteria for Imposing Administrative Fines) #

The criteria for imposing administrative fines under Article 47(1) of the Act shall be as specified in Appendix 2.