2004

2004. 10. 18 인도네시아의의료기기인허가제도 1. 관련조직및법령 2. 인허가제도

인도네시아의료기기인허가제도 < 차례 > 관련조직및법령 1 (1) DirJen POM (The Indonesian Director General of Food and Drugs) 1 (2) 관련법령 1 인허가제도 2 (1) Stipulation on Registration Implementation 2 (2) 의료기기카테고리와부속카테고리 (Medical Devices Categories and Sub-categories) 5 (3) 수입된의료기기의등록을위한등록신청서식 (Application Forms for Registration of imported Medical Devices) 9 참고자료 11 한국보건산업진흥원수출입정보은행

관련조직및법령 (1) DirJen POM (The Indonesian Director General of Food and Drugs) 국립보건국 (The National Ministry of Health) 산하기관인도네시아내의의료기기, 화장품, 가정용보조기구 (household supplies) 의등록을관장 (2) 관련법령의료기기, 화장품, 가정용보조기구의위험성으로부터소비자들을보호하기위해 DirJen POM은규제 No. 140/Menkes/Per/III/ 1991, "Obligation to Register Medical Devices, Cosmetics, and Household Health Supplies" 를공포함이규제에대한세부시행규칙 (implement) 으로규제 No. 1477/C/ SK/IV/91, "Directives for Registration of Medical Devices, Cosmetics and Household Health Supplies" 를공포함 한국보건산업진흥원수출입정보은행 1

인허가제도 (1) Stipulation on Registration Implementation 1) 등록신청자 (Registration Applicants) 인도네시아국내의료기기는허가된지역제조업자에의해등록되고, 수입의료기기는해외제조업자로부터위임을받은지역 (local) 의료기기유통업자에의해등록 ( 해외회사들이지명한지역의료기기유통업자 ) 2) 등록방법 (Mothod of Registration) 신청자가신청서를작성하고, DirJen POM에제출 - DirJen POM(Directorate for Drug and Medical Devices Control at J1. Percetakan Negara 23, Jakarta 10560, Indonesia) 서식이불완전하면신청자에게통지 3) 신청서 (Application Forms) 의료장비의등록을위한신청서작성 - 시약 / 체외진단기기의등록 ( 동일한방식, 라벨링, 포장을한경우또는크기나포장이품목의안정성에영향을미칠정도가아닌경우 ) - 의료용가위나집게, 기타이런종류에속하는의료기기들에대한등록 - 같은재질이나라벨링을갖지않고, 크기가다양한위생냅킨이나석고와같은일회용 (disposable) 품목의등록 신청서는 3통을작성하여, 2통은 Directorate for Drug and Medical Devices Control에제출되고, 마지막 1통은신청자가보관함 한국보건산업진흥원수출입정보은행 2

신청자는 formula, components, product specifications, production methods (for reagent or in vitro diagnostic products), finished product specifications, stability (for in vitro diagnostic medical devices and syringes), functions, methods, and labeling including labels, brochures 등에대한신뢰할만한정보를제공해야만함 메인신청서는반드시인도네시아어로작성해야하며, 지원자료와문서 ( 동봉물 ) 들은인도네시아어나영어로작성해야함 4) 등록평가 (Registration Evaluation) 등록번호를얻기전에, 신청서는규제 No. 140/Menkes/Per/III/1991 에의해서평가됨 5) 평가결과 (Evaluation Result) 신청서와동봉물이지시에따라정확히준비되면완전한것으로인정 신청서가부정확하게기입되었으면불완전한것으로인정 6) 등록에대한의사결정 (Decision Making on Registration) 완전한신청서를받고난후 3개월이내에보건국 (The Ministry of Health) 을대신하여 DirJen POM이신청서에대한판결 (decision) 을작성함 판결은아래와같음 - 신청서가승인되면등록번호가수여됨. 등록번호는승인된신청데이터가변경되지않는경우무제한유효함. 등록번호는국내의료기기의경우코드KD, 수입의료기기의경우코드KL을사용함 - Completion of Data : i) DirJen POM은신청서평가후추가자료가필요한경우신청자에게통지할것임 ii) 추가자료는통지후 3달이내에제출되어야함 iii) 추가자료는재평가되고자료가완전하면등록번호를부여할것임 iv) 자료제공을이행하지않으면신청서가거부됨 한국보건산업진흥원수출입정보은행 3

v) 자료가불완전한경우신청자는새신청서를작성해야할수도있음 - 등록거부되는경우 i) 의료장비에대한표준이나규제의불이행 ii) 이미등록된제품과같은제품명사용 iii) 부정확한추가자료 (incorrect additional data) 7) 제품데이터변경 (Product Data Changes) 등록번호를얻은후의료기기의 formula, 재질, 라벨, 포장이나다른요인이변경되면, 신청자는변경신청서 (the Data Changes Application forms) 를통해변경된정보를등록해야함 변경신청서는규제 No. 140/Menkes/Per/III/1991에의해서 평가되고, 결과는서면으로통지됨 8) 포장크기의증가 (Increase in the Size of Packaging) 포장의크기가증가하면, 이미등록번호를얻은의료기기에대해포장크기증가보고서 (Packaging Size Increase Report form) 를작성해야함 9) 승인된등록취소 (Cancellation of Approved Registration) 아래와같은경우 Director General에의해등록취소가가능 신청자의요청이있는경우 평가나모니터링에근거하여, 불량제품인경우 - 제품이건강에안전하지않거나유해한경우 - 제품의품질이표준이하인경우 - 승인된라벨과다른경우 : 다른합법적회사의상품명을도용한경우를포함 Director General은등록취소에대한내용을등록소지인에게서면으로통지할것임 한국보건산업진흥원수출입정보은행 4

10) 재등록 (Re-registration) 규제 No. 140/Menkes/Per/III/1991의공포이전에획득한등록번호를가진의료기기는반드시신청서를작성하여재등록 재등록은단계 (in stages) 로이루어지고, 회람장 (Circular Letter) 을통해통지 (2) 의료기기카테고리와부속카테고리 (Medical Devices Categories and Sub-categories) 1) Clinical Chemistry and Toxicology Equipment a. Clinical chemistry tests b. Clinical laboratory equipment c. Clinical toxicology tests 2) Hematology and Pathology Equipment a. Biological coloring b. Culture media and tissue products c. Pathology equipment and accessories d. Reagent specimens e. Automatic & semi-automatic hematology equipment f. Manual hematology equipment g. Hematology packets h. Hematology reagents i. Products used for making blood preparation, and preparations originating from blood 한국보건산업진흥원수출입정보은행 5

3) Immunology and Microbiology Equipment a. Diagnostic equipment b. Microbiology equipment c. Serology reagents d. Immunology laboratory reagent and equipment e. Immunological tests f. Immunology tumor antigen tests 4) Anaesthesia Equipment a. Anaesthesia diagnostic equipment b. Anaesthesia monitoring equipment c. Anaesthesia therapeutic equipment d. Other anaesthesia equipment 5) Cardiology Equipment a. Cardiology diagnostic equipment b. Cardiology monitoring equipment c. Cardiology prosthetic equipment d. Cardiology surgical equipment e. Cardiology therapeutic equipment 6) Dental Equipment a. Dental diagnostic equipment b. Dental prosthetic equipment c. Dental surgical equipment d. Dental therapeutic equipment e. Other dental equipment 한국보건산업진흥원수출입정보은행 6

7) Ear, Nose and Throat (ENT) Equipment a. ENT diagnostic equipment b. ENT prosthetic equipment c. ENT surgical equipment d. ENT therapeutic equipment 8) Gastroenterology-Urology (GU) Equipment a. GU diagnostic equipment b. GU monitoring equipment c. GU prosthetic equipment d. GU surgical equipment e. GU therapeutic equipment 9) General & Private Hospital (G&PH) Equipment a. G&PH monitoring equipment b. G&PH therapeutic equipment c. Other G&PH equipment 10) Neurology Equipment a. Neurology diagnostic equipment b. Neurology surgical equipment c. Neurology therapeutic equipment 11) Obstetric and Gynaecology (OG) Equipment a. OG diagnostic equipment b. OG monitoring equipment c. OG prosthetic equipment d. OG surgical equipment e. OG therapeutic equipment 한국보건산업진흥원수출입정보은행 7

12) Optical Equipment a. Optical diagnostic equipment b. Optical prosthetic equipment c. Optical surgical equipment d. Optical therapeutic equipment 13) Orthopaedic Equipment a. Orthopaedic diagnostic equipment b. Orthopaedic prosthetic equipment c. Orthopaedic surgical equipment 14) Physical Health Equipment a. Physical health diagnostic equipment b. Physical health prosthetic equipment c. Physical health therapeutic equipment 15) Radiology Equipment a. Radiology diagnostic equipment b. Radiology therapeutic equipment c. Other radiology equipment 16) General Surgery and Plastic Surgery Equipment a. General & plastic surgery diagnostic equipment b. General & plastic surgery prosthetic equipment c. General & plastic surgery surgical equipment d. General & plastic therapeutic equipment 한국보건산업진흥원수출입정보은행 8

(3) 수입된의료기기의등록을위한등록신청서식 (Application Forms for Registration of imported Medical Devices) 1) 등록신청서기재사항 의료기기의유통라이센스를가진인도네시아회사이름 - 완전한주소와전화번호 기기등록을위해권한을위임해준공장이나해외회사의이름 - 완전한주소 의료기기의상표명 (Brand Name) 의료기기의카테고리와부속카테고리 기타정보 ( 모양, 색, net 중량, 수량 (volume), 포장, 크기, 종류 (types), 성분 (components), 기타 ) 신청서는아래와같은동봉물 (enclosures) 을포함할것임 (DirJen POM으로부터얻을수있음 ) - Enclosure AA: Formula and Components - Enclosure BB: Specification and Quality Assurance - Enclosure CC: Usage and Labeling - Enclosure DD: Catalog and Sample - Additional information 2) 수입의료기기에대한신청서기재사항 등록을수행할회사의이름 - 의료기기유통허가를가진인도네시아회사의이름, 유통허가증의사진복사를동봉 - 완전한주소와전화번호, 가능하면사서함도포함시킴 등록을위해위임한해외회사나공장의이름, 완전한주소와가능하면사서함, 아래의동봉물 - 인도네시아보건국에상품등록을요청한공장이나해외회사로부터의위임장의사진복사 - 공장조직의구조 (Factory organizational structure) 한국보건산업진흥원수출입정보은행 9

라벨링 (labels, brochures or manual) 과일치할의료기기의상표명, 해외에서의공식적인거래여부와거래되었던국가에대해설명, 원산지로부터아래에대한공식적인정보를동봉 - 원산지의법에의해의료기기생산의모든기준에대한이행여부 - 원산지에서의합법적인공급여부 - 해외로수출된의료기기의경우, 수출국가의통제시스템에의해승인되었지여부와그국가의이름, 그국가내의인도네시아대사관에의해이사실에대한증명 카테고리와부속카테고리 (Category and Sub-category) Sec 2. 의료기기의카테고리와부속카테고리참조 기기에대한설명 - 형태 (Shape) : 고체, 액체, 기구등 - 색 (Color) - 포장 (Packaging) : 포장된의료기기에대해설명 - 중량 / 크기 - 종류 (Type) - 성분 (Components) 신청서에는동봉물 AA, BB, CC, DD( 각각사본 1부 ) 가포함됨, 만약사본 1부로부족한경우추가로사용 신청서는회사의대표, director, 유통업자가지명한기술적대리인에의해서명되어야하고, 장소, 날짜, 완전한이름과회사의인장이포함되어야함 동봉물 CC : 1) 제품사용에관한정보를규정 2) 기기매뉴얼동봉 3) 제품코딩과의미 - 제품코딩의견본을제공하고그의미를설명 4) Labeling, including container labels, packaging, brochures, 기타서류들 동봉물 : the label and packaging, brochures and writings that accompany the product. 한국보건산업진흥원수출입정보은행 10

참고자료 1. 미상무성국제의료기기규정홈페이지 (http://ita.doc.gov/td/mdequip/indonesiaregs.html) 한국보건산업진흥원수출입정보은행 11