Example Sample1 Manufacturing process flow.

1 0 Sample1 Manufacturing process VisualInspection (Qualityconformanceinspection) Injectionmoldingprocess Visual Inspection)(Electric resistance measurement ) Weldingprocess Coating Cleaning / Packaging / 2 Visual Inspection)(Leakage current measure) Cleaning Sterilizedpackagingprocess VisualInspection Bioburdentesting Sterilization (EOG (BItesting)(Determinationofresidualethyl eneoxide) (Visual Inspection)StoragePackaging / LabelingFinal VisualInspection 5 Visual Inspection Decision on whether the products an be raw material from supplier and Mutual relations of QMSABC Mfg.

2 Site(Registration)Main assembling plantMNO, Co.(Registration)Design facilityDEF, Mfg. site(Registration) Sterilizer JKLD istribution Center(Registration) Distribution Center STU, Mfg. plantGHI Distribution Center Inspection Storage QMS(ABC, Co. QMS(DEF, Co.) Same QMSA greement InformationexchangeAgreementExampleMarke ting Authorization Holder JKL, Ltd. 2 Form2 Outline of MAH/RMS (1/2)Nameof mfg. siteAddress of mfg. siteRegistration numberDateof initial registrationRegistrationperiodAs of DD/MM/YYNumbers of employees (including part time employees)Total:Mfg.)

3 Department :QA/QCdepartment :Number of mfg. products (Number of products exported to Japan should be described in parenthesis.)Class IClass IIClass IIIC lass IVNumber of products Product utilizing medicine/cellular and tissue-based productSpecified biological productProduct utilizing nanomaterialsMicro machineProduct absorbed into human bodySpecial designated medical deviceOutline of Manufacturing siteExample3 Form2 Outline of RMS (2/2)Not applied article 4 and article 83 of QMS ordinance (MHLW Ministerial Ordinance in 2004)If export , please describe your export destination and trade name of the products except Japan.

4 Export destinationTrade name of the productChanges history of mfg. site(pleaseselect items, and specify details.) Changes of product / mfg. process (ifimportant) Changes of QMSorganization Changes of topmanagement or management representative Others ( ) NoChangeDetailsHistory of QMS inspections by regulatory authorities and registered certification body over the past 5 regulatoryauthorities/registered certification bodyInspection dateThe products subject to the inspectionInspection resultsType of Inspection(On-site or Desk-top)Name, address, and applicable mfg.

5 process of critical suppliersNameAddressApplicable mfg. process Example4 Form3 Products list for nameTrade nameApproval (certification) approval (Certification)Expirydate* registration123456* If sterilizer or distribution center are different, write these mfg. site s name. Example5 Sample3 Layout of RMSSite boundary ofRMS QBuildingRBuildingSBuildingT photograph or location map of a building affecting a subject of map of RMSE xample6 Sample4 Floor plan of RMS(1/2)apassagewaySterilizer1 Sterilizer2 ManufacturingSterilizationPackagingWareh ouseManufacturingReceivingShippingISO Class 7differentialpressure(>10Pa)

6 SterilizerExamplePeople flowMaterial EquipmentModel InjectionMolding EquipmentSK-123 WeldingEquipmentLy-222 AutoclaveST999 Representative list of inspection GageBlocks123F MicroscopeF111 ElectronicscaleSEW124 Representative list ofmfg. equipmentSample4 Floor plan of RMS(2/2)Example8 Sample5 organization chartPMDA TAROP resident and CEOABC company Organization ChartKIKOU JIROQ uality & Regulatory Affairs ReconstructionRegulatory Affairsdepartment QA department QC department Mfg department Mfg.

7 Site A Mfg. site BPurchasing department FinanceHuman ResourceGlobal operationManagement RepresentativeTop ManagementExample9 Sample6 List of documents identified with QMSQMSA rticleDocuments identified with the QMSC ontrol ofdocumentsRetentionperiodNameNumberSect ion 2 QMSA rticle5 General equirementsfor QMSA rticle 6 Documentation of other documentation specified by the laws, others and ordinances related to the PMD 7 Quality ManualArticle 8 Control of about control of documentsArticle 9 Control of about control of records **Example10 Sample7 SeihinHyojyunSyoRequirementsReference documents(name, number, etc)Location(sites) ,Genericname(commonname), (P2/D2 DMF1devicerequirementspec73345) ,drawingsandspecificationsorcompositiona ndcontentMechanicalSpecification7810(Spe c-controlledenvironmentarea)Testspecific ationT78910(Electricaltestspecification, IPG)

8 ProductSpecificationP78910(DMF1RV2produc tconfiguration) (MT123,SOP04,SOP05)** (P2/D2 DMF1devicerequirementspec)**Example11 Sample8 Implementation of validation status Mfg processValidation dateMfg. siteReasonsMfg equipmentIQOQPQI njectionmoldingN/AN/A1/3/2014 ABCRe-ValidationInjection molding machine A-01 Soldering1/1/20141/2/20141/3/2014 ABCR epairing Soldering ironD-01, D-02 Soldering iron D-01, D-02 Welding1/1/20141/2/20141/3/2014 ABCC hangeequipmentUltrasonic welding machine M-01 Sterilization1/1/20141/2/20141/3/2014 DEFP urchasenew sterilizer(EOG)SterilizerP-04 PackingN/A1/2/20141/3/2014 ABCC hangesetting value Temp:105 C 110 C Heat Sealer P-01**Exampl