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03.2011 CE SGS 65 (CMEF)

01 CE 02 SGS 65 (CMEF) +86 (0) 10 6845 6699-841 +86 (0) 10 6845 7979 73 16100142 e-mail: cn.ssc@sgs.com hk.ssc@sgs.com 03 IVDD 04 05 06 08 11 12 18 22 IEC 62304 25 SGS 2011 SGS 27 SGS 28 2011 SGS SGS SGS SGS

SGS SGS

P01 CE SGS United Kingdom Limited 93/42/EEC 98/79/EC CE SGS CE SGS CE NBOGNotified Body Operations Group NBOG BPG 2010-3 NBOG / CE0120 SGS United Kingdom Ltd Notified Body 0120 CE + CE 3 5 (Recertification audit due before) CE 3 ISO 17021 SGS CE SGS SGS HK.CN.MDDHub@sgs.com

P02 SGS 65 (CMEF) 2011 4 16 SGS 65 (CMEF) 65 12 2011 4 16-4 19 SGS 6 L03 -L04 (CMEF) 1979 30 SGS

P03 IVDD SGS Freeman Feng 90/385/EEC 93/42/EEC 98/79/EC 2008 1 98/79/EC 98/79/EC 1998 2003 6 7 2007/47/EC 90/385/EEC 93/42/EEC 2010 3 21 2008 2 GHTF 2008 IVD 2010 6 29 98/79/EC 3 2010 9 15 (DG SANCO) SGS 2010 10 2011 2 23 4 B/C/D IVD GHTF/SG1/N046:2008 3 QMS IVD 2010 10 11 DG SANCO (Roadmap) IVD GHTF IVD (Clinical validity)dg SANCO 2011 3 IVD IVD (CE Marking) IVD IVD 98/79/EC CE IVD IVD IVD CE SGS 98/79/EC 5 0120 IVD 6 1.http://ec.europa.eu/enterprise/sect ors/medical-devices/documents/re vision/index_en.htm 2.http://ec.europa.eu/enterprise/polic ies/single-market-goods/regulatorypolicies-common-rules-for-product s/newlegislative-framework/index_ en.htm 3.http://ec.europa.eu/enterprise/new sroom/cf/itemlongdetail.cfm?item_i d=4404 4.http://ec.europa.eu/consumers/sec tors/medical-devices/files/recast_d ocs_2008/ivd_pc_outcome_en.pdf 5.http://ec.europa.eu/enterprise/new approach/nando/index.cfm?fuseact ion=notifiedbody.notifiedbody&ref e_cd=epos_43442 6.http://www.medicaldevices.sgs.com 183 87% GHTF IVD

P04 SGS Freeman Feng 2010 12 MEDDEV 2.7/3 MEDDEV 2.7/4 2008 12 MEDDEV2.7/2 2009 12 MEDDEV2.7/1 Rev 3 UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC) MEDEV2.7/3 (MEDDEV 2.7/3 SAE Report Table v1) (SAE) MEDDEV2.7/3 SAE SAE 90/385/EEC 7 93/42/EEC X GHTF SG5/N32010 90/385/EEC 7 93/42/EEC X MEDDEV2.7/4 Class III 1. MEDDEV 2.7/3 90/385/EEC 93/42/EEC (CLINICAL INVESTIGATIONS:SERIOUS ADVERSE EVENT REPORTING 2. MEDDEV 2.7/4 (GUIDELINES ON CLINICAL INVESTIGATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES) 4 http://ec.europa.eu/consumers/secto rs/medical-devices/documents/guideli nes/index_en.htm

P05 SGS Freeman Feng 2011 1 5 Guidance for the Interpretation of Significant Change of a Medical Device1 2011 4 1 2003 (Medical Devices Regulations (SOR/98-282)2 MDR) MDR II III IV MDR 26 MDR 34 6 III IV III IV MDR 1 3 9 1-9 10 III IV 1. Guidance for the Interpretation of Significant Change of a Medical Device,http://www.hc-sc.gc.ca/ dhp-mps/md-im/applic-demande/g uide-ld/signchng_modimportante-e ng.php 2. Medical Devices Regulations (SOR/98-282),http://laws.justice. gc.ca/eng/sor-98-282/index.html

P06 SGS Vicky Tam 138 303 MDACS IVD 2004 11 26 IV 2005 11 14 III II 2006 10 13 2007 3 23 2007 7 17 D 2009 12 1 IVD (MDACS) (IVD) MDACS IIIIII IV 4 (IVD) A BC D 4 2004 MDACS IV III II

P07 MDACS (LRP) LRP LRP LRPLRP (LRP) GHTF ISO ISO 13485:2003 MDCAS MDCAS SGS (MDCO) SGS IVD MDCO MDACS MDCO SGS MDACS CEISO13485CMDCAS SGS http://www.medicaldevices.sgs.com cn.ssc@sgs.com

P08 SGS Freeman Feng Therapeutic Goods Act 1989 Therapeutic Goods (Medical Devices) Regulations 2002 TGA GHTF ISO 13485 (ARTG) TGA, Therapeutic Goods Administration GHTF 1989 GHTF 5 IVD 4 I IIa IIb III

P09 1) 2) 3) 4) 5) 6) ISO 14971 ISO 13485 ISO 10993 ISO 60601 ISO 11135 TGA I 1. 2. TGA ARTG 3. ARTG TGA 4. 5. I I IIa IIb III AIMD 1. 2. TGA 3. 4. TGA 5. ARTG 6. ARTG 7. I I IIa IIb III AIMD 1. TGA 2. 3. TGA 4. ARTG 5. ARTG 6. III AIMD

P10 TGA ARTG (SPONSOR) ARTG GMDN (MRA) CE SGS 10 1. 2. TGA 3. 4. TGA 5. ARTG 6. ARTG 7. TGA 1. Australian Therapeutic Goods Act 1989; 2. Australian Therapeutic Goods (Medical Devices) Regulations 2002 3. AUSTRALIAN REGULATORY GUIDELINES FOR MEDICAL DEVICESversion 1.0;

P11 SGS Jiangchen Li Flash CT 100 20 90% CT 1300 2000-3000 20 2200 20 8-10 200 200 80% CT 90% 90% 85% 90% 80% 90% MRCT GE

P12 90% 4 8500 GE 8500 1.5 2009 48,992 5000 4 5 2 2000 3000 4000 1 10 1 1 21

P13 ISO 17664:2004 SGS Freeman Feng ISO 17664:2004 CEN/TC 204 ISO/TC 198 2004 3 1 ISO 17664:2004 ISO17664:2004 6

P14 A B ISO17664:2004 3 3.33.11 ISO 17664 3.3 3.5 3.4 CSSD CSSD 3.1 A 3.2 3.6 3.7

P15 4 ISO 15223ISO 7000 ISO 17664 3.8 3.10 3.9 5 6 ISO 17664:2004 A A.1 1 3.11 ISO 17664:2004

P16 B B.2 2 1 A.1 A B C D G H 1) I J (Deposition) 3) 3) 3) N.A 2) 2) Tmax 1 2 3 + N.A.

P17 2 XXX XXX XXX XXX (ph7) yy C 1 2 XX XX 3 1 2 3XX yy C XX 120 C z kg y C x y C 44123 456 789 1. ISO17644:2004 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices 2. WS 310.1-2009 1 3. WS 310.2-2009 2 4. WS 310.3-2009 3 5. Proper Maintenance of Instruments 9th edition, 2009, www.a-k-i.org.

P18 SGS Cherry Chen ERA 10 RoHS RoHS REACH WEEE 2007/47/EC RoHS RoHS (2002/95/EC) (Restriction of Hazardous Substances) 2006 7 1 6 1000V 1500V WEEE 1A 10 8 9 RoHS 2008 12 3 WEEE (2002/96/EC) RoHS (2002/95/EC) RoHS 1 RoHS 2014 2016 2020 2 CE EC I MDD93/42/EEC 3RoHS WEEE 10 4 (HBCDD)2 - (DEHP) (BBP) (DBP)

P19 2014 RoHS RoHS FDA REACH REACH REACH REACH REACH REACH REACH (Registration) REACH 7 1t/a 3 (SVHC) REACH 57 SVHC-Substances of Very High Concern 67/548/EEC REACH III SVHC REACH 7 (2) 0.1 W W 1 REACH REACH SVHC 46 SVHC http://echa.europa.eu/chem_data/aut horisation_process/candidate_list_tab le_en.asp ECHA SVHC 2010 12 1 SVHC 2011 6 1 2010 12 1 SVHC 6 ECHA SVHC 2011 6 1 2011 6 15 SVHC SVHC SVHC SVHC SVHC 0.1% 1 SVHC REACH

P20 XVII RoHS WEEE WEEE Waste Electrical and Electronic Equipment Directive(2002/96/EC) RoHS WEEE 75 65 4 EuP EuP 2005/32/E EuP EuP CE EuP IEC IEC 60601-1-9 IEC 60601-1:2005 IEC 60601-1 IEC 60601-1:2005 EN 60601-1:2006 1.3 IEC 60601-1:2005 IEC 60601-1:2005 IEC 60601-1-9 REACH SVHC 2014 RoHS 2008 12 3 WEEE COM2008 8109 3 12848/09

P21 1 2 BOM PVC 3 SGS RoHS CE 510(K) CCC FDA CQC 4 WEEE EuP IEC 60601-1-9 5 PFMEA RoHS RoHS 6 REACH SVHC 7 8 XRFICP IECQ QC080000 IECQ QC080000 1-10%

P22 IEC 62304 SGS IEC 62304 ISO 14971 2007 IEC 62304 93/42/EEC(MDD) M5(2007/47/EC) MDD FDA ANSI/AAMI/IEC 62304:2006 EN/ISO IEC 62304 IEC 62304 A B C a) b) c) A

P23 B A A B ISO/IEC 90003:2004 3.14 ISO/IEC 90003:2004 3. 28 5.3.5 A B C IEC 62304:2006 5.1 5.2 IEC 62304:2006 5.3 IEC 62304:2006 C (5.4) (5.5.1) (5.5.25.5.3) (5.5.2, 5.5.3)5.5.4 (5.5.5) (5.5.5) 5.6 IEC 62304:2006 5.7 IEC 62304:2006 (5.8.4) 1

P24 1 A SOUP SOUP SOUP SOUP A SOUP SOUP C SOUP IEC 62304 MDD IEC 62304 IEC 62304 IEC 62304

P25 SGS Yaner Yan OEM 2008 SMT 10 GMP SFDA

P26 1 2 3 4 5 SO2 ISO14644 SGS 1 2 3 4 5 cn.ssc@sgs.com

P27 SGS 1. ISO 13485 2. ISO 13485 2 1 3. ISO 9001 ISO 13485 4. (Directive 93/42/EEC) 5. (Directive 93/42/EEC) MDD 6. (Directive 98/79/EC) IVD 7. (Directive 98/79/EC) IVDD 8. PPE(Directive 89/686/EEC) 9. FDA (21CFR820510(K)QSIT) 10. (CMDCAS) 11. (JPAL) 12. (TGA) 13. HK (MDACS) 14. (ISO 14971) 15. (Clean Room, ISO 14644) 16. (ISO 10993) 17. (Process Validation) 18. (ISO 11135 ISO 11137) 19. (IEC 62304) 20. (MEDDEV 2.7.1ISO 14155) 21. (Clean Room) 22. MD IVD (NB-MED/2.5.1) 23. (IEC 60601SafetyEMC Testing) 24. (Supplier Control/Own Branding) 25. 3 2 2 2 2 2 3 2 1 1 1 1 2 1 1 3 1 2 2 1 2 1

P28 5 6 7 8 9 10 11 12 15-17 19-21 14-16 23-25 24-26 9-11 4-6 27-29 28-30 ISO 13485 3 2500 25-27 16-18 13-15 18-20 1-3 14-16 7-9 15-17 14-16 10-12 15-17 22 14 ISO 14971 1 1200 21 FDA 27-28 GMP (QSR) 510 (K) 2 1800 25-27 21-22 1 2 3 010-68457980 021-61402621 0755-83197517 SGS www.medicaldevices.sgs.comcn.ssc@sgs.com

03/11/SSC_GLXHB_NO.1 2011