Article 1(Purpose) #
The purpose of these Rules is to prescribe matters delegated regarding the subject matters of, and procedures for, new health technology assessment and the composition, operation, etc. of the Committee for new health technology assessment, all of which are referred to in Articles 53 through 55 of the Medical Service Act, and those necessary to implement such Act.
Article 2(Subject Matters of New Health Technology Assessment, and Other Related Matters) #
(1) The subject matters of new health technology assessment under Article 53 of the Medical Service Act (hereinafter referred to as the "Act") shall be as follows: <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
1. Health technologies, the safety and efficacy of which is yet to be assessed, and which the Minister of Health and Welfare deems necessary to be subject to assessment;
2. Health technologies whose purposes of use, subject-matter of use, methods for practice, etc. of any other health technology assessed as a new health technology are changed and which the Minister of Health and Welfare deems necessary to be subject to assessment.
(2) Regarding any such health technology (hereinafter referred to as "new health technology subject to suspended assessment") using any medical device for which permission to manufacture or import is granted (hereinafter referred to as "specific medical device"), based on attached data on clinical trials under Article 9 (2) 6 of the Enforcement Decree of the Medical Devices Act, and satisfying each of the following requirements, the Minister of Health and Welfare may, notwithstanding paragraph (1), suspend the new health technology assessment of such health technology until one year after the date it is first used to treat a patient: Provided, That this shall not apply where the specific medical device is deemed to have essentially the same structure, principle, performance, and method of use as any other specific medical device which is used for any existing new health technology subject to suspended assessment or where the new health technology assessment with respect to any health technology using the specific medical device has already been conducted: <Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
1. Documentary evidence shall exist evidencing clinical services provided to patients comparing a health technology falling under Article 3 (5) 1 with the health technology using the specific medical device: Provided, That this shall not apply where it is impossible to conduct any comparative research because the relevant health technology subject to suspended assessment is a health technology without any comparable alternative health technology or which is used for any rare disease;
2. The purpose of use (including herpes diseases or diseases for which medicine is efficacious) of the relevant medical device shall be specific.
Article 2-2 #
Deleted. <by Ordinance of the Ministry of Health and Welfare No. 474, Jan. 24, 2017>
Article 3(Procedures for New Health Technology Assessment) #
(1) Each person who intends to apply for either new health technology assesment or the suspension of new health technology assessment in accordance with Article 2, shall file an application of attached Form 1 or 2 with the Minister of Health and Welfare after verifying whether the relevant new health technology is eligible for health care benefits under Article 9-2 (1) of the Rule on the Standards for Health Care Benefits under the National Health Insurance Program: Provided, That where, in accordance with Article 64 of the Enforcement Decree of the Medical Devices Act, a person who intends to apply for new health technology assessment has requested the Minister of Food and Drug Safety or the Medical Device Information and Technology Assistance Center to provide materials concerning permission, etc., for manufacture to an institution entrusted with related business in accordance with Article 9, and also has applied for the verification as to whether the relevant new health technology is eligible for health care benefits, that person shall be deemed to have received the verification as to whether the relevant new health technology is eligible for health care benefits. <Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
(2) Even where no request is made under paragraph (1), if necessary, the Minister of Health and Welfare may conduct an assessment of new health technology ex officio. <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
(3) Upon receipt of an application for the suspension of new health technology assesment in accordance with paragraph (1), the Minister of Health and Welfare shall verify as to whether the requirements under Article 2 (2) are satisfied and then notify the findings to the applicant and the head of the Health Insurance Review and Assessment Service within 30 days from the date of application, except in extenuating circumstances. In such cases, if the health technology for which such application is filed satisfies all the requirements under Article 2 (2), the Minister of Health and Welfare shall publicly notify the purposes of use, subject-matter of use, methods of practice, etc. of the relevant health technology. <Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
(4) The Minister of Health and Welfare shall refer to the Assessment Committee for deliberation any health technology with respect to which he/she receives an application for new health technology assessment under paragraph (1) or which requires ex officio assessment under paragraph (2). <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
Article 3-2(Special Cases concerning Procedures for New Health Technology Assessment) #
(1) Where a person who intends to receive new health technology assessment under Article 2 (1) satisfies all of the following requirements, he/she may apply for new health technology assessment, while also applying for manufacturing permission, conditional manufacturing permission, or permission to change medical devices (hereafter in this Article, referred to as "manufacturing permission, etc."), or applying for import permission, conditional import permission, or permission to change such devices (hereafter in this Article, referred to as "import permission, etc.") under Article 6 (2), 7 (1), 12 (1) (including where it is applied mutatis mutandis in Article 15 (6)), or 15 (2) of the Medical Devices Act, notwithstanding Article 3 (1); and in such cases, the person shall also apply for the verification as to whether the relevant new health technology is eligible for health care benefits under the proviso to Article 9-2 (1) of the Rules on the Standards for Health Care Benefits under the National Health Insurance Program:
1. The assessment must be conducted for health technology using the medical device for which the person intends to obtain manufacturing permission, etc. or import permission, etc.;
2. The medical device for which the person intends to obtain manufacturing permission, etc. or import permission, etc., must be used for the same purpose as the health technology for which he/she intends to receive new health technology assessment.
(2) A person who intends to apply for new health technology assessment under the former part of paragraph (1), shall submit an application for new health technology assessment in attached Form 1, to the Minister of Health and Welfare via the Minister of Food and Drug Safety.
(3) Upon receipt of an application for new health technology assessment in attached Form 1 under paragraph (2), the Minister of Health and Welfare shall examine whether the application meets each of the requirements specified in paragraph (1) and handle it according to the following classifications within seven days:
1. Where the application meets each of the requirements specified in paragraph (1): The application shall be referred to the Assessment Committee for deliberation;
2. Where the application fails to meet each of the requirements specified in paragraph (1): The application shall be returned to the applicant via the Minister of Food and Drug Safety.
(4) Where deemed necessary to assess the health technology referred to the Assessment Committee for deliberation under paragraph (3) 1, the Minister of Health and Welfare may request the Minister of Food and Drug Safety to submit relevant data or his/her opinion.
Article 3-3(Control of Side Effects of New Health Technology Subject to Suspended Assessment) #
(1) Where a manufacturer, importer, repairer, seller, and lessor of any specific medical device, or an establisher of a medical institution, recognizes that there has occurred, or is likely to occur death or any side effect to human body as a result of practicing any new health technology subject to suspended assessment, until the time when an assessment of the new health technology is completed after referral thereof to new health technology assessment is suspended in accordance with Article 2 (2), he/she/it shall immediately report the fact to the Minister of Health and Welfare, and maintain the related records, as publicly notified by the Minister of Health and Welfare. In such cases, the Minister of Health and Welfare may request the Minister of Food and Drug Safety for cooperation, such as presentation of materials which are reported to the latter in accordance with Article 31 of the Medical Devices Act with respect to the specific medical devices for which the relevant new health technology subject to suspended assessment, is used.
(2) Where reported in accordance with paragraph (1), the Minister of Health and Welfare may request the Assessment Committee to examine the level of risk of the safety of the new health technology subject to suspended assessment.
(3) If requested in accordance with paragraph (2), the Assessment Committee shall examine the level of risk of the safety of the new health technology subject to suspended assessment; and if the level of risk is deemed high, shall interrupt the suspension of new health technology assessment and notify the head of the Health Insurance Review and Assessment Service of the findings of examination.
(4) Where it is verified that no report has been made although grounds exist to report any side effect under paragraph (1), the Minister of Health and Welfare may interrupt the suspension of new health technology assessment under Article 2 (2).
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015]
Article 3-4(Assessment Procedures for New Health Technology Subject to Suspended Assessment) #
(1) Where new health technology assessment is suspended in accordance with Article 2 (2), a manufacturer or importer of any specific medical device shall apply for health technology assessment in accordance with Article 53 of the Act within one year from the date the new health technology subject to suspended assessment is used for the first time to treat patients.
(2) Where a manufacturer or importer of any specific medical device fails to apply for new health technology assessment in accordance with paragraph (1), the Minister of Health and Welfare may conduct new health technology assessment ex officio in accordance with Article 3 (2).
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015]
Article 4(Notification of Findings of Assessment, and Other Related Matters) #
(1) The Minister of Health and Welfare shall notify the applicant as to whether the relevant health technology is subject to assessment within 90 days after receipt of an application under Article 3 (1), 3-2 (2), or 3-4 (1). <Amended by Ordinance of the Ministry of Health and Welfare No. 425, Jul. 29, 2016>
(2) Where the relevant health technology is subject to assessment, the Minister of Health and Welfare shall notify both the applicant (via the Minister of Food and Drug Safety if the assessment findings relate to an application filed pursuant to Article 3-2 (2)) and the head of the Health Insurance and Assessment Service of the assessment findings of the safety and efficacy of that health technology, within 280 days (140 days if the health technology relates to in-vitro diagnostic tests or genetic tests) after receipt of an application; and shall publicly notify the assessment findings of the safety and efficacy, purposes of use, subject-matter of use, methods for practice, etc. of such health technology. <Amended by Ordinance of the Ministry of Health and Welfare No. 424, May 31, 2016; Ordinance of the Ministry of Health and Welfare No. 425, Jul. 29, 2016>
(3) Despite the fixed period for notification of the assessment findings of in-vitro diagnostic tests or genetic tests specified in paragraph (2), such period may be extended by up to 140 days, only once, if additional examination is required or any other unavoidable circumstances exist. In such cases, the Minister of Health and Welfare shall notify, in advance, the applicant (via the Minister of Food and Drug Safety if the application is filed pursuant to Article 3-2 (2)) of the ground, period, etc. for the extension. <Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 424, May 31, 2016; Ordinance of the Ministry of Health and Welfare No. 425, Jul. 29, 2016>
[This Article Wholly Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015]
Article 5(Request for Materials, and Other Related Matters) #
If necessary for deliberation, the Assessment Committee or a sub-committee may request any related specialized academic association or organization, etc. for necessary materials or request any related experts, etc. to appear before such committee to hear their opinions. <Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
Article 6(Committee for New Health Technology Assessment) #
(1) The Assessment Committee shall deliberate on the following matters: <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
1. Whether any health technology is subject to new health technology assessment under Article 2;
2. Matters concerning assessment methods for new health technologies;
3. Examination findings of sub-committees regarding the safety and efficacy of new medical technologies;
4. Matters concerning the modification of the procedures and standards for assesment;
5. Matters concerning the utilization of findings of assessment;
6. Examination findings of a sub-committee regarding the selection, operation, etc. of restrictive health technologies;
7. Other matters referred for deliberation to the Minister of Health and Welfare or the Chairperson of the Assessment Committee.
(2) The Vice Chairperson of the Assessment Committee shall be elected by and from among its members, and act on behalf of the Chairperson where the Chairperson is unable to perform his/her duties due to any extenuating circumstance.
(3) The Assessment Committee shall have one secretary to perform its affairs, who shall be appointed by the Minister of Health and Welfare from among public officials under his/her jurisdiction. <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
(4) Meetings of the Assessment Committee shall be convened by the Chairperson either where requested by at least of 1/3 of the members thereof or where deemed necessary by the Minister of Health and Welfare or the Chairperson of the Assessment Committee. <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010>
(5) A majority of the members of the Assessment Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of at least a majority of those present.
(6) In addition to matters provided for in paragraphs (1) through (5), other necessary matters concerning the deliberation and operation of the Assessment Committee, shall be determined by the Chairperson of the Assessment Committee via the deliberation of the Assessment Committee.
Article 7(Specialized Assessment Committees by Area) #
(1) The areas of specialized committees under Article 54 (6) of the Act, shall be as follows:
1. Specialized medical committee on internal medicine;
2. Specialized medical committee on surgery;
3. Specialized medical committee in areas other than internal medicine and surgery;
4. Specialized medical committee on dentistry;
5. Specialized Medical committee on oriental medicine.
(2) A specialized committee under any subparagraph of paragraph (1) shall be comprised of at least 20 members. <Amended by Ordinance of the Ministry of Health and Welfare No. 236, Apr. 24, 2014>
(3) From among those recommended by related organization or academic society, or the Assessment Committee, the Minister of Health and Welfare shall appoint or commission the persons who have affluent professional knowledge and clinical experience in the relevant area as the members of specialized committees. <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
(4) The term of office of the members of specialized committees shall be three years, and may be consecutively renewed.
(5) In addition to matters provided for in paragraphs (1) through (4), other matters necessary for operating specialized committees, shall be determined by the Chairperson of the Assessment Committee via the deliberation of the Assessment Committee.
Article 8(Disqualification of, and Refrainment by, Committee Members) #
(1) A member of the Assessment Commission or a sub-committee (hereafter referred to as the "member" in this Article) who falls under any of the following cases shall be disqualified from deliberation and resolution on the Assessment Committee and from the examination of the sub-committee: <Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
1. Where the member or the member's current or former spouse is either a party (where the party is a corporation or organization, including the executive officers thereof) to the relevant agenda item or a person holding any right or duty jointly with the party to such agenda item;
2. Where the member has a family relationship with any party to the relevant agenda item;
3. Where the member has ever conducted any advisory affair, research, service or appraisal with respect to the relevant agenda item; and has received any remuneration, such as money or goods, in return therefor;
4. Where the member or any corporation to which the member belongs is the current or former agent of any party to the relevant agenda item;
5. Where it is unlikely to expect fair and objective deliberation and resolution due to the member's private or economic interest, etc. with any person concerned with the relevant agenda item.
(2) Where the member falls under any ground for exclusion referred to in paragraph (1), he/she shall voluntarily abstain from the deliberation and resolution on the relevant agenda item. <Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
(3) The member who intends to apply for abstention due to any ground for exclusion under paragraph (1) and (2) shall file an application (confirmation) of attached Form 3 with the Chairperson of the Assessment Committee. <Amended by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015>
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 236, Apr. 24, 2014]
Article 8-2(Prohibition from Disclosure, etc. of Related Content) #
(1) No member of the Assessment Committee or member of any sub-committee shall disclose to any third person, any content which comes to his/her knowledge with respect to deliberation, etc, of any agenda item.
(2) Each member of the Assessment Committee and each member of sub-committees shall present a written pledge in attached Form 4, to the Chairperson of the Assessment Committee before the first meeting he/she attends.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015]
Article 8-3(Dismissal of Members) #
Where a member of the Assessment Committee or a member of a sub-committee falls under any of the following subparagraphs, the Minister of Health and Welfare may dismiss such member:
1. Where the member fails to refrain when he/she is aware he/she falls under any ground for disqualification referred to in the subparagraphs of Article 8 (1);
2. Where the member discloses any related content, in violation of Article 8-2 (1);
3. Where the Assessment Committee determines that the member significantly compromises the fair performance of assessment.
[This Article Newly Inserted by Ordinance of the Ministry of Health and Welfare No. 353, Sep. 21, 2015]
Article 9(Entrustment of Affairs) #
The Minister of Health and Welfare may entrust the following institutions with the affairs related to assessment, such as collection and research of materials, in accordance with Article 55 of the Act. <Amended by Ordinance of the Ministry for Health, and Welfare and Family Affairs No. 1, Mar. 3, 2008; Ordinance of the Ministry of Health and Welfare No. 1, Mar. 19, 2010; Ordinance of the Ministry of Health and Welfare No. 157, Aug. 31, 2012; Ordinance of the Ministry of Health and Welfare No. 236, Apr. 24, 2014>
1. The National Evidence-based Healthcare Collaborating Agency under Article 19 of the Health and Medical Service Technology Promotion Act;
2. A non-profit corporation incorporated by the Government or operational expenses of which are fully or partially subsidized by the Government;
3. A non-profit corporation with professional personnel and capabilities for new health technology assessment.