EC DIRECTIVE 98/79/EC (体外診断薬指令)について
Contents
1. M 0000000000000 93 42 000000 0 0000000000000000000 45 00000000000000000 000000000 0000000000 11000000000000 00 0000 00000000000000000 EU 0 NO 0000000 098 79 ET E 00000000000000000 0000 0000 98 79 nnnnnnnnnnnnnnnnmn 000000000000000 o o o o nnnnnnmnnnnnnnn 98 79 EC 0 0000 Annex ll 000000000000000001 O 00 O0 000 0000 0000000 00000000000000 0000 00 0000000000000000000 000000000000 000000000000000 000 00000000000000000 0 5013485 0 000000 000600 US 00 ced ed ka ne nmnnnnnnnnnnnnnnmnn 0 00009 ses eed fa 0000 Accredited Person 000 0 Ecrit PROTI 0000 Recognised 0 0 0000000 p 0000001 00000000000000000002. 00000 000 05 An 000 0000 EUH 0000000000000000 List Bg B 0 000000 0000000000000000000 00000000000000000 0000 0 0 DNotified Body JO 0000 O OG List B00 0000000000 00000000000000 0000000000000 000000000 ListA List B 000 000000000 000000000 00000000 00000000000 0 00 00 0000 00 0 00 0 nist 0000000000000 ONotified Body List B0 0 0 00 0 0000000000 000000000000000000 00000000000000 00045 AJ 0000000000000 000000 0000000000000 Technical Documentaion 0000 000000 M 00000000000000 JO UOD U List AJ 000000000 00000000000000000 EC Design Exanination ECI 0 O 000 DAnnex tO 0000000000 0000000000000000000 0 00000000000000000 00000000000000000000 00000000000000000 0000000 2000000000000 000000000000000000 000000000000000000 00000000000000000000 0000000000000000000 0000000 0000000000000 0000000000000 AQ D 00000000 0000000000000000000 000000000000000000 000000 000 000 000000 000000000000 00000 00000000000 Notified Body 0 0 Annex IV 00000000000 0000000000 Yes LIST A Annex V and Annex VII 00000 Yes 0000 IV 00000000000 ya Yes LIST B Annex V and Annex VII Em ag n d anna va Yes 0000 V and VI 8 Yes 000 List B000 00000
3. 2009 20 AUTHOR Williams Global IVD Certification Manager SGS Sharon IL 000000 0000000 00 EC Directive 98 79 EC 000000000000000000000000000000 00000000000 0000000000000000000 00000000000000 0000000000000 000 000 00000000000 O0O00000000000000000000000000000 0000000000000000000000000000000 OOO000000000000 ED REOR 1 KITTEN ETT ss esse ess 2 I 0 O 00000 0060 DIRECTIVE 98 79 EG D 000000 d IV EC DIRECTIVE 98 79 EC a 8 ee nen 9 LOT 00 000 00000000000000000000000000000 00 Global harronisationg O O 00000000000 0000000000000000000000000000000000000000000000 000000000 0 0000000 EC Directive 98 79 1 7 00 0 00000000000 00 00 A00 0 0000 OO000000000000000000000000 6E Making 0 0 0000000020030 000000000 00000000 EC Directive 98 79 0 0 098 79 EC 000000000000 150134851 TO 00000000 00000000000000000000000000000000000000000000000000000000 0000000000000 s ooo ooo EI oO 00000000000 98 797 0000000000000000000000000000000000000000 0 Notified Body 0 0 0000000000 LOfficial oural of the European Conmunities L 331 vol 41 7 Decerrber 1998 COCO 0000000000000 2000 000 00000000000 000000000000000000000000000000000 00000000000000000000000000000000000 00000000000000000000000000000000000 0 00000000000000000000000000000 0000000000000000000000000000000000000 0 LI pH 0
4. 0 0000000000000 0000000000000 00000000000000 0 0000000000 0000000000000 0000 00000000 OO 0000000000000 0000000000000 0 Annex XI 0000000 0000000000000 0000000 00000 00000000 000 000000 0000000 DEU EEA 000000 000000 1000000000000 0000000000 LI 98 79 EC 119 000 00000 00000000000000000 00000000000000000 000 50 000000000000000 00 0 98 79 EC 80 00000 00000000 OOOIOOO O ao 9 98500600 5 MEDDEV 2 12 1 rev 6 on medical device vigilance system dated Dec 2009 IV EC DIRECTIVE 98 79 EC
5. 0 S Sa ke r 0000 000000 99 79 00000 000000000000000001 0000000000 EU USA CANADA JAPAN 0000 EUJ 000 00000000 000000 00000 98 79 EC 000000021 21CFR 000000 MDR 000 0000000 00000000000 00000000000 00000000000 00000000000 Health Canada 0000000000 00000000000 00000000000 000000000000 5100010 000 000000 00000 Dsum 000000 0000000000 QSRO 000000000000 Accredited Persons Program 000000000000 00000000000000 15013485 under CMDCASQ 0000 00 i 000000000000 Annex 10 List A List 21 CFR 862 864 866 00000000000 JMDNI 0000000 00000 0000000000000 000000 00000 V 0000000000 0000100000000 ODO LIT tl IV GMDN Global Medical Device Nomenclature system http ww gmdnagency org v O L 98 79 EC 00 00000 00000000000000000000000000000 0000000000 000000000000000000000000000000000000000 0 00 Notified Bodies OO 000 000000000 0000000 00000000000000000000 Notified Bodies 0 000000000 0000000000 00 000000000000000 Notified Body 0 00000000000 000000000000000000000000000000000000000 000000000 00000000000000000000000000000 00000000000 OHoooooadg 000000 scs1100 5651 400000000000000 sie lens 565 1000000000000000 00000000000000000000 Global IVD Certi
6. 00 000000 Annex IIl section 6 0000000000000 Va Yes GENERAL IVDS Annex n a No 0000000000000 000000 000000000000000000 9 00 0000000 0000000 00000000000000000 00000000000000000 0000000000000000 00000 90000000 LIEUL d 1 U U U 00000000000000000 00000000000000000 0 O00000000000 000000000000000000 00000000000000000000 oS LI LI LI LI LI OOOO 8 1 8700000000 0000000000000 O00000 F0000000 00000000000000 0000000000000 00000000000000 0 g LI LI oo dag LI L3 L3 C L3 L3 L3 L3 L3 C3 GALEGO C3 C3 C3 C3 L3 LI LI LI LI LILI OClOHOOlOOOlOlOClOOlOO OOCOOO OH T m r3 1 oO LI DU DU OG LI C3 F3 p4 BJ p p b H pe L3 L3 m3 000 0000 Notified Body 0 O 00000000 0000000000 0000000000000 0000 00000 00000 0000000000000
7. 0000 2008 000000 0000000000000000000 3000 4 000 0000000000000000 3 Official ournal of the European Communities 136 4 6 1985 1 4 Recast of the Medical Devices Directives Summary of the responses of the Public Consultation Brussels 5 December 2008 ENTR F 3 D 2008 39582 T LT UL C EC DIRECTIVE 98 79 ECT DO 0000 00000000000 000000000000000000 98 79 dr MEME 00000000000000 00000 100000000000000000 000000000 0000000000 000000000000000000 0000000000000000000 1000000000000000000 0000000000 000000000000000000 98 IEC OU 00000000000 000000000000000000 0000000 000000000 000000000000000000 0000000000000000 000000000000000000 000000000000000 0000000 00000000000000000 000000000000000000 0000000000000000 000000 0000 DDirective Amex 000000000000000 00000000000000000 00000000000000000 0000000000000000000 0000000000000000 0000 000000000000 000000000000000000 000000000 150134851 1000 00000000 0000000000 000000000000000606 0000000000000000 0000000000000000000 anm 000000 0 00000000 0000 00000 00000000 t Notified Body I0000000000000000000 0000000000000098 79 ECC D 000000000000000000 00000000000000000 00000000 0000000000000000000 Directive 100000000
8. 000000 000000000000000000000000000000 000000000 000000000000000000000000000 000000000000000000000000000000000 0590 0000000 098 79 000 0000000000000000000 Corrpetent Authority 0 000 0 00 00 000000000 0000000 0000000000000000000000000000000000000 0000000000000 OU OCEJ 0000000000000 098 797 EC 000000040 00000000000000 00000000000 0 0 00 270 0000000 O O OU U 0000000084 0000000000000000000000000 OOOOIOIOI mnmruuuurucdzudrur3 Ooo LI 0 0 0 0 0 0 0 0 0 2 List of National EU Competent Authorities http ec europa eu enterprise sectors medical devices files list of contact points within the national en pdf EC DIRECTIVE 98 79 EC 98 77 000000000000000000000000000000000000000000000000000 00000000000000000000000000000000000000000000 1957 000000000000000 E00 00 1985 0000000000000000000000000000003 1990 0000000000 AIMD 90 385 0 0 1993 000000 MDD 93 42 1993 00000000 00006000 1994 0 O 0000000000000 00040000 300 00000 00000000 0000000000 000000000000 00000000 1998 98 79 1999 000 190 0000000000000000000000000000 0084200000000 2003 0 0000000000000000000000000000000 15013485 0 0 00 000000000000000 2007 2007 47 EC LI MD O
9. 0000000000000000000000000000000000000000000000000 565 SA 2010 00000000 0 ALL RIGHTS RESERVED SGS SA 201 WWW SGS COM MEDICALDEVICES WHEN YOU NEED TO BE SURE SGS
10. fication Manager SGS 00000000000000 00000 000 Sharon Wiliams 00000000000 ScS000000000000010101 00000000 00 0080 000000 80000000000000000 0000000000000000000 0000000000 0000000000 00000040000 Notified Body A EN CAES redet RE OO 00000000000000000000 000107 00000000000000 e e 000000000000 00000 000 00000000000000 000000000 650 000000000 00008890 000000000000 0600000100n00056s0 1 00000000 100000000000000000 1 0 0 00 0 06013485 D 98 79 EC 005650 005 Bri D DD 000000 90 0000000000001 0000000000000 000000 009000000000000000 10000000000000 0000000000000000000 SY REM Notmed Body 1000 0000 000000000000000000 0000 020100 0000 Oust 00 0000000000000000 0000000000000 WWW Sgs corr medicaldevices 00 ekson 0 0000000000000 0 000000000000000 65 5 ODD 000 0000 00 00 00000000000 000 00000000 000000 000000 00000000000000000000000000000000000000000000000000000000000 0000000000 000000000000000000000000000000000000 000000000 0000000000 0000000000000000000000000000000000000000000000000000000000000000000 0000000000000 000000000 0000000000000 0000 000000000000000 0000000000000 00000000 00000000000000000000000000000000000005 6 0 000000 000000000000000000000000000000000000000000000000000000000000000000 000000000000000000000 0000
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