General Company Information: 회사정보 Company Name: Contact Pers.: Address: Telephone: FAX: Email: Website: Subsidiary of/owned by: Branch/Facilities: Please complete the following table with the number of employees for each facility and department. In case you have several shifts, please indicate the number of shifts and the number of the employees on each shift. (In case there are more than 2 facilities, please make a copy of this table and list all the applicable facilities.) 아래의테이블에싸이트별부서의인원수를표기하여주시기바랍니다. 교대근무가있다면교대수와각교대별인원수를표기해주세요. 시설이두군데이상있다면이페이지를복사하여각싸이트별로기술하여주시기바랍니다. Facility: Number of Shifts: Number of the employees per shift: Design 설계 Materials/Purchasing 자재 / 구매 Manufacturing 생산 Packaging 포장 Sterilization 멸균 Customer Service/Sales 고객서비스 Shipping 수송 Service 서비스 Quality Assurance 품질 Regulatory Affairs 규격 Administration 행정 Total 총인원 For more than one facility: Address Contact Person Telephone Number of employees Please attach organizational charts and a description of responsibilities. File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 1 of 9
Subcontracting: Are important parts of the design/manufacturing subcontracted to external companies and in which way are subcontractors included in the QS (e.g. by auditing of subcontractors, are included into the QS- System to be certified, by incoming inspection, are certified to ISO 9001 or AIMDD/MDD/IVDD)? 설계 / 생산의주요부분들이외주되고있습니까? 그렇다면, 외주업체들을어떤방법으로품질시스템에포함시켰나요? ( 예 ; 인증된품질시스템을외주업체감사시고려하시나요? 수입검사시 ISO 9001 혹은 AIMDD/MDD/IVDD를고려하시나요?) Design SW - Design Sub-assemblies Packaging Sterilization Servicing Accessories Other Name of subcontracted companies How included? Are there any products manufactured by other companies which are placed on the market under your own name (OEM)? 다른업체에의해 OEM으로제조되고있는제품이있습니까? If yes, which? Do certificates for these products exist? (please attach copies) OEM 으로제조되고있는제품들의승인서가있습니까? 있다면복사본을첨부해주시기바랍니다. Please complete the applicable attachment(s), at least one must be completed: 귀사에해당되는첨부를작성하여주시기바랍니다. 적어도한가지는작성되어야합니다. Attachment 1: QM-System EN ISO 13485 / ISO 9001 (1 page) Attachment 2: AIMDD (90/385/EEC) (1 page) Attachment 3: MDD (93/42/EEC) (2 pages) Attachment 4: IVDD (98/79/EEC) (1 page) Attachment 5: Derivatives of Human Blood or Human Plasma (2000/70/EEC) (1 page) Animal Origin (2003/32/EEC) Drug-Device Combination Submitted by: Title: Date: / / File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 2 of 9
Attachment 1: Quality Management System 품질관리시스템 Should the whole company be audited? 회사전체를심사하여야합니까? If not, which departments should be audited? 그렇지않다면, 해당부서들을명기하십시오 Current Quality System Status: 품질시스템현황 t certified Documented only to US QSR s Presently certified by to Quality System Documentation/Structure: 품질시스템문서 / 구성 One quality manual/set of procedures covers all facilities 회사전체를관리하는하나의품질매뉴얼 / 절차서 One quality manual/separate procedures for each facility 공통품질매뉴얼 / 각시설별별도의품질절차서 Separate quality manual/procedures for each facility 각시설별별도의품질매뉴얼 / 절차서 Other - describe or attach diagrams Quality System Audits Requested (use additional forms as needed): to Facility: Quality standards: EN ISO 13485 w/o* Design ISO 13485 / CMDCAS recognized registrar ISO 9001:2008 w/o Design Pre-Audit: Target Date / / Certification Audit: Target Date: / / Facility: Quality standards: EN ISO 13485 w/o* Design ISO 13485 / CMDCAS recognized registrar ISO 9001:2008 w/o Design Pre-Audit: Target Date / / Certification Audit: Target Date: / / Facility: Quality standards: EN ISO 13485 w/o* Design ISO 13485 / CMDCAS recognized registrar ISO 9001:2008 w/o Design Which activities regarding the products should be covered by the scope of the certificate? 승인서에표기되어야할제품관련인증범위를표기하여주시기바랍니다. *w/o: without File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 3 of 9
Attachment 2: AIMDD Please complete this page for each product category (devices with same description/intended use/indications). Please provide product literature, instructions for use, brochures etc., if available. 다른제품군의경우제품군별로각각기술하여주시기바랍니다. ( 제품설명 / 사용목적 ) (Use only one form per a) Product Category: Product category) b) Intended use: c) UMDNS (GMDN optional)* Product Category name: d) UMDNS (GMDN optional)* Product Category number: *Please underline menclature System. UMDNS: Universal Medical Device menclature System/GMDN: Global Medical Device menclature (see http://www.gmdn.org). Product Examination Requested: 제품시험의뢰 t applicable Requirements depend on assessment route selected. Discuss with your TÜV Product Service representative. Product description: AIMDD Annex 3 (Type Examination) AIMDD Annex 2.4 (Design Dossier Examination) For each product that requires a type- or design examination, please submit a complete Design Dossier or Device Documentation (for the content see TÜV Product Service information sheet Technical Files/Design Dossiers ). Conformity Assessment Route Requested: 적합성평가의뢰 AIMDD Annex 2.4 combined with Annex 2.3 (Complete Quality Assurance System) AIMDD Annex 3 combined with Annex 5 (Assurance of Production Quality) AIMDD Annex 3 combined with Annex 4 (EC Verification) In case of Conformity Assessments according to AIMDD Annex 3+5 or 3+4, does the Annex 3 certificate already exist? AIMDD Annex 3+5 혹은 3+4에따른적합성평가의경우, Annex 3 인증을보유하고있습니까? (If yes, please attach Annex 3 certificates) Facilities involved in Product: 제품에관련된시설들 Design: Sterilization: Manufacturing: Service of external components (if applicable): File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 4 of 9
Authorized EC Representative (only if necessary for EC-Directives): 유럽대리인 (EC Directive 가해당되는경우만필요합니다.) Company Name: Contact Pers.: Address: Telephone: FAX: Email: Website: File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 5 of 9
Attachment 3: MDD Please complete this page for each product category (devices with same description/intended use/indications). Please provide product literature, instructions for use, brochures etc., if available. 다른제품군의경우제품군별로각각기술하여주시기바랍니다. ( 제품설명 / 사용목적 ) Use only one form per a) Product Category: Product category) b) Intended use: c) UMDNS (GMDN optional)* Product Category name: d) UMDNS (GMDN optional)* Product Category number: *Please underline menclature System. UMDNS: Universal Medical Device menclature System/GMDN: Global Medical Device menclature (see http://www.gmdn.org). Classification: MDD I* sterile MDD I** measuring function MDD IIa MDD IIb MDD III Classification Rule per MDD Annex IX: Product Assessment Requested: 제품평가의뢰 t applicable Requirements depend on assessment route selected. Discuss with your TÜV Product Service representative. Product description: MDD 1 Annex III (Type Examination) MDD 2 Annex II.4 (Design Dossier Examination) 1 2 For Class IIb or Class III Products For Class III Products For each product that requires a type- or design examination, please submit a complete Design Dossier or Device Documentation (for the content see TÜV Product Service information sheet Technical Files/Design Dossiers ). Conformity Assessment Route Requested: 적합성평가의뢰 t applicable MDD 3 Annex II (Full Quality Assurance System) MDD 3 Annex IV (EC Verification) MDD 3 Annex V (Production Quality Assurance) MDD 3 Annex VI (Product Quality Assurance) 3 For Class I* sterile devices only Annex V is applicable. Class I 멸균제품은 MDD 부록 V 만가능합니다 For Class I** measuring devices Annex IV, V or VI is applicable. Class I 측정기기는부록 IV, V 혹은 VI 이가능합니다 File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 6 of 9
Facilities involved in Product: 제품과관련된시설 Design: Sterilization: Manufacturing: Service: For Class IIb or Class III MDD Products: 등급 IIb / III 의료기기 In case of Conformity Assessments according to MDD Annex III+V or III+IV or III+VI, does the Annex III certificate already exist? MDD 부록 III+V 혹은 III+IV 혹은 III+VI에따른적합성평가의경우, 부록 III 인증을보유하고있습니까? (If yes, please attach Annex III certificates) Authorized EC Representative (only if necessary for EC-Directives): 유럽대리인 (EC Directive 가해당되는경우만필요합니다.) Company Name: Contact Pers.: Address: Telephone: FAX: Email: Website: File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 7 of 9
Attachment 4: IVDD Please complete this page for each product category (devices with same description/intended use/indications). Please provide product literature, instructions for use, brochures, etc., if available. 다른제품군의경우제품군별로각각기술하여주시기바랍니다. ( 제품설명 / 사용목적 ) (Use only one form per a) Product Category: Product category) b) Intended use: c) EMDS* Product Category name: d) EMDS* Product Category number: *EMDNS: European Diagnostics Market Statistics menclature (see http://www.edma-ivd.be) Classification: IVDD, List A IVDD, List B IVDD, Self-testing Product Assessment Requested: 제품평가의뢰 t applicable Requirements depend on assessment route selected. Discuss with your TÜV Product Service representative. Product description: IVDD 1 Annex V (Type Examination) IVDD 2 Annex IV.4 (Design Examination) IVDD 3 Annex III.6 (Design Examination) 1 2 3 For Annex II List A or List B Products to be combined with IVDD Annex VII For Annex II List A Products to be combined with IVDD Annex IV For Self-testing devices except blood glucose measurement systems For each product that requires a type- or design examination, please submit a complete Design Dossier or Device Documentation (for the content see TÜV Product Service information sheet Technical Files/Design Dossiers ). Conformity Assessment Route Requested: 적합성평가의뢰 IVDD Annex IV (Production Quality Assurance) IVDD Annex VII (Full Quality Assurance System) Facilities involved in Product: t applicable Design: Sterilization: Manufacturing: Service: Authorized EC Representative (only if necessary for EC-Directives): Company Name: Contact Pers.: Address: Telephone: FAX: Email: Website: File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 8 of 9
Attachment 5: Derivatives of Human Blood or Human Plasma, Animal Origin, Drug-Device Combination Product: Derivatives of Human Blood or Human Plasma: 사람의혈액혹은혈장파생물 Is a substance which can be considered to be a derivative of human blood or human plasma an integral part of the device? 사람의혈액혹은사람혈장에서파생되었다고려될수있는물질이제품원료물질로사용됩니까? If yes, is the derivative of human blood or human plasma covered by an official registration for the European market? 만일그렇다면사람혈액혹은사람혈장의파생물이공식적으로유럽시장에등록되었습니까? Was the product or a predecessor consulted at the European Agency for the Evaluation of Medicinal Products (EMEA) before? 본제품혹은이전제품의의약품평가를위해유럽의관청 (EMEA) 에서자문을받았습니까? Animal Origin: 동물유래 Is your product manufactured utilizing animal tissue or derivatives rendered non-viable? 귀사의제품이동물유래혹은사멸한파생물을이용하여제조됩니까? If yes, which species/tissue(s)/derivative(s) and who is responsible for processing (derivation) of the animal tissue? 만일그렇다면, 어느종류 / 물질 / 파생물이며그리고누가동물유래물질에대한 ( 파생물 ) 공정의책임이있습니까? Drug-Device Combination: 약품-의료기기조합 Is a substance which can be considered to be a medicinal product an integral part of the device? 의약품으로간주될수있는물질이제품의일부부품입니까? If yes, is the medicinal substance covered by an official registration for the European market? 만일그렇다면의약품물질이유럽시장에공식적으로등록되었습니까? (If yes, please attach registration) Was the product or a predecessor consulted according MDD Annex II section 4.3 before at one of the European Competent Authorities? 본제품혹은이전제품이유럽관할당국중하나에서 MDD Annex II section 4.3 에의한자문이이루어졌습니까? Is the substance genetically engineered? 물질이유전자조작물입니까? File: Med_F_03.06e.doc Revision: 9 Effective: 2009-09-01 Page 9 of 9