??????? ??????????? ????? ?????????? ??? IN VITRO ???????????: ????????? ??????????? ? ???????? ?????

1
??????? ??????????? ????? ?????????? ??? IN VITRO
??????????? ????????? ??????????? ? ????????
?????
2
????? ??????? ??????????? ????????????

• ??? ??????????? ??????? ?????????? ??? ??????
  ????????, ??????? ???????? ?????????????
  ??????????? ? ???????????? ?????????? ?
  ??????????? ??????????, ????????? ?? ?????,
  ????????????, ??????????? ? ???????? ????????,
  ?????????????? ??????? ? ?.?.

3
????????? ????????????? "???????????? ??????????"
? ????????????, ?????????????? ? ????????????
???, ??????? ??? ?????? ???????? ??? ????????????
? ????????? ?? ?????. ?????????????????
??????????? ????????? ?? ?????????????? ??????,
????????? ? ???????????????, ????????????? ?
????????? ??? ???????????? ???????????? ????????
?? ?????????????? ?? ?????? ????????????
??????????. ??? ????????? ?? ?????
??????????????? ????????? ? ???????? ?
??????????? ??????? ???????????? ????? ? ?????
???????????? ?????????? ? ??????????
???????????. ??????????, ??? ????? ???????,
????????????? ? ???????????? ? ??????????????
???????????, ????????????? ????????????
???????????.
4
?? ?????? ???????????? ????? ???????????????
??????????????? ???????????? ??? ??
?????????????? ?????????????, ? ?????, ?????
?????, ??????????? ??????, ??????? ????????????
????????????? - ??????? ??. ????????? ??????
???????????? ??????? ? ???????????? ??????????
?????????? ?? ????????? ???????, ?????????? ?
??????? ?????? 93/465/EEC ?? ??????????
???????????? ?? Council Decision 93/465/EEC on
the CE conformity marking.
5
????????? ???????? ????????? ?????? ????????????,
??????? ??????? ?? ???? ??????? ? ???? ?????????
??????. ????? ??????? ??????? ??????? ?????, ?
???? ?????????? ?????? ????????????? ???????????
???????????, ??? ?????????? Notified Bodies,
???????????? ? ??????????? ????????????? ????????.
6
??????????????? ?????????? ???
III ????? ??????? ????
?????
II? ????? ??????? ????
??????
II? ????? ??????? ????
??????? ?????
I ????? ?????? ????
????? ?????
7
(No Transcript)
8
EU Directives

• The Medical Devices Directive (MDD) ???????????
  ??? ???? ??????????? ??????? ? ??????????? ?????
  ??????? in vitro ???????????, ??????????? ,
  ????????????? ? ????????????? ???????, ??????? ?
  ?????? ????????.
• The Active Implantable Medical Devices Directive
  (AIMDD) ??????????? ??? ???? ???????? ?????????
  (????????) ? ??????????????? ???????????,
  ??????????????? ??? ??????????? ? ????????
  ????????.
• The In Vitro Diagnostics Directive (IVDD)
  ??????????? ??? ???? ??????????? ?????????
  (????????) ? ????-??????, ???????????? ???
  ????????? ???????? ??? ??????????? ????????????
  ????????? (???????) ????????.

9
EU Directives

• The In Vitro Diagnostics Directive (IVDD)
  ??????????? ??? ???? ??????????? ?????????
  (????????) ? ????-??????, ???????????? ???
  ????????? ???????? ??? ??????????? ????????????
  ????????? (???????) ????????.

7.12.98 EN Official Journal of the European
Communities L 331/1 I (Acts whose
publication is obligatory) DIRECTIVE 98/79/EC OF
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27
October 1998 on in vitro diagnostic medical
devices
10

• Medical device means any instrument, apparatus,
  appliance, material or other article, whether
  used alone or in combination, including the
  software necessary for its proper application,
  intended by the manufacturer to be used for human
  beings for the purpose of- diagnosis,
  prevention, monitoring, treatment or alleviation
  of disease,- diagnosis, monitoring, treatment,
  alleviation or compensation for an injury or
  handicap,- investigation, replacement or
  modification of the anatomy or of a physiological
  process,- control of conception,and which does
  not achieve its principal intended action in or
  on the human body by pharmacological,
  immunological or metabolic means, but which may
  be assisted in its function by such means

11
DIRECTIVE 98/79/EC on in vitro diagnostic medical
devices

• ??????? ???????????? ?????????? (???) ???
  ??????????? in vitro - ??? ????? ???,???????
  ???????? ?????????, ??????????? ????????,
  ????????????, ??????????? ??????????, ???????,
  ????????????, ????????, ?????????????, ????????,
  ???????????? ???????? ??? ? ??????????, ?
  ??????? ????????????? ????????????? ???
  ????????????? in vitro ??? ???????????? ????????
  ????? ? ??????, ?????? ?? ????????? ????????,
  ????????????? ??? ??????????????? ???? ?????????
  ??????????- ?????????? ???????????????? ???
  ??????????????? ?????????, ???- ??????????
  ?????????? ????????, ???- ????????????
  ???????????? ? ????????????? ? ??????????????
  ????????????, ???- ? ????? ????????????????
  ???????????.

12
DIRECTIVE 98/79/EC on in vitro diagnostic medical
devices

• ?????????? II
• ?????? A - ??????? ??? ??????????? ?????? ?????
  AB0, ????? (C, c, D, E, e) anti-Kell,- ???????,
  ??? ??????????? ???????? ???-???????? (??? 1 ?
  2), HTLV I ? II, ????????? B, C ? D.
• full quality assurance
• ???
• EC type-examination
• ????????? ?
• production quality assurance

13
DIRECTIVE 98/79/EC on in vitro diagnostic medical
devices

• ?????????? II
• ?????? ? - ??????? ??? ??????????? ?????? ?
  ?????,- ???????, ??? ????????? ????????,
  ?????????????, ??????????????, ??????????,
  ???-????????,-
• full quality assurance
• ???
• EC type-examination
• ????????? ?
• production quality assurance ???
• EC verification

14
ANNEX XCE MARKING OF CONFORMITY

• The CE conformity marking shall consist of the
  initials CE taking the following form
• If the marking is reduced or enlarged the
  proportions given in the above graduated drawing
  must be respected,
• the various components of the CE marking must
  have substantially the same vertical dimension,
  which may not be less than 5 mm. This minimum
  dimension may be waived for small-scale devices.

15
? ????????? ??? ??? in vitro ??????????? ???????
????? ??????????? ??????? Common Technical
Specifications (CTS), ???????????????
??????????????? ???????? ?????? ? ??????????
???????????????? ???????????, ???????? ???????
??????, ?????? ? ????????? ?????????.
16
(No Transcript)
17
???????? ?? ?????????? ?????? ??????????? ????????????????? ??????????, ??????????? ? ??? ??? in vitro ??????????? ???????? ?? ?????????? ?????? ??????????? ????????????????? ??????????, ??????????? ? ??? ??? in vitro ??????????? ???????? ?? ?????????? ?????? ??????????? ????????????????? ??????????, ??????????? ? ??? ??? in vitro ??????????? ???????? ?? ?????????? ?????? ??????????? ????????????????? ??????????, ??????????? ? ??? ??? in vitro ???????????
European Standards Bodies Standard reference Titles Publication OJ
  EN 12322 1999/ A12001 In vitro diagnostic medical devices Culture media for microbiology Performance criteria for culture media C 182 of 2002-07-31
  EN 13612 2002 Performance evaluation of in vitro diagnostic medical devices C 314 of 2002-12-17
  EN 13640 2002 Stability testing of in vitro diagnostic medical devices C 314 of 2002-12-17
  EN 13641 2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents C 314 of 2002-12-17
18
Code of Federal RegulationsTitle 21, Volume
8 CHAPTER I- FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
(CONTINUED) PART 809 - IN VITRO DIAGNOSTIC
PRODUCTS FOR HUMAN USE Subpart A--General
Provisions Sec. 809.3 Definitions. (a) In vitro
diagnostic products are those reagents,
instruments, and systems intended for use in the
diagnosis of disease or other conditions,
including a determination of the state of health,
in order to cure, mitigate, treat, or prevent
disease or its sequelae. Such products are
intended for use in the collection, preparation,
and examination of specimens taken from the human
body. These products are devices as defined in
section 201(h) of the Federal Food, Drug, and
Cosmetic Act (the act), and may also be
biological products subject to section 351 of the
Public Health Service Act.
19
Device Class and Regulatory Controls Class I.
General Controls With Exemptions Without
Exemptions Class II. General Controls and
Special Controls ? ????????????? ???
???????????? Class III. General Controls and
Premarket Approval
20

• ????? I. ????? ???????? ????????
• ??????????? ??????????? (Establishment
  Registration, ?? ????? FDA 2891), ??????? ???????
  ???????????????? ? ???????????? ? 21 CFR, ??????
  807.20, ????? ??? ????????????, ?????????????,
  ?????????????.??????????? ???????????, ??????,
  ?? ??????? ???????????????? ? FDA.
• ???????? ? ?????? ??????????? ??????? (Medical
  Device Listing, ?? ????? FDA 2892), ???????????
  ?? ?????. ???????????? ??????????? ??????? ?
  ???????????? ? GMP (21 CFR, ????? 820).
• ?????????? ??????????? ??????? ? ???????????? ?
  ???????????? ? 21 CFR, ????? 801 ??? 809.
• ?????? ?????????????? ??????????? (premarket
  notification 510 (k)).

21
????? II. ????? ???????? ? ??????????? ????????
??????????? ???????? ????? ???????? ???????????
?????????? ? ??????????, ???????????? ?????????
???????????????? ??????????? ? ??????????????
??????????
22
????? III. ????? ???????? ? ?????????????
?????????/?????????????? (Premarket Approval)
CBER ?????????? ??????????? ???????, ???????????
? ?????, ?????????, ???????, ???????????? ?
?????????? ??????????????? ?????, ???????????
????? ? ????????? ??????????. CBER ??????????
?????? ??? ??????????? ???, HTLV ? ??????????????
?????????.CBER ?????????? ???? ???????? ???
??????????? ???????????? ????? ????????? ?
??????????? CBER ? CDRH ? ????????? ???????????
???????.
23
The Global Harmonisation Task Force (GHTF) on
medical devices (??????? ?????? ??????????
???????????? ????????? ???????????
?????????) GHTF ??????, ??????????
?????????????? ???????????? ???????, ????????????
????????? ??????????? ?????????, ?
?????????????? ??????????????? ????????
?????????????? ?? ??????????? ??????, ??????,
?????????, ???????????? ?????, ? ??????.
24
?????????????? ?????? ????????? ?????????????
????????? ??????????? ????????????? ?????????? -
???? ?? ??????? ???????? ? ???????? ?????????? ??
????????? ???????? ????????????. ??????? ?????
?????? ? ???? ??????????? ????? ???????? ??????
? ??????????? ?????????????.
25
????????????? ??????? ??????????? ??????????? ?
???????????? ??????????. ?????? ??????????? ???
??????????, ??? ?????? ?????????? ??????
????????????. ? ??????????? ??????????? ??????
???? ????????? ?????????? ??????????? ??????????
? ???????????? ?????????. ???? - "?????? ????? ?
???????? ?????, ??????????? ???????????????? ?
??????? ?????????, ?????? ?????????? ????? ?
?????????????? ????????, ???????? ? ???????????
??????????????".
26
???????????? ????????? ????? ?????????
?????????????? ?????????? ? ???????? ?????????
(?????? ??????, ?????, ??????, ???????? ? ?.?.)
???????????? ????????? ???????????? ??????????
?????????????? ???????????? ?????????????,
??????????? ??????????? - ????????????
????????????? ???? ????????? ?????????? ?
????????????. ????????? ??????????? ???????????
? ???????????? ?????????? ?????? ???? ???????????
(???????????????) ? ????????????????
?????????????? ???????????.
27
?????? 12. ???????? ?????????????? ??????????????
?????????????? ? ???????????? ?
?????????? ????????????? ??????????
?????????? ????????????? ????? ??? ??????????
?????????? ???????? ????????? ????????????????
??? ?????????? ?????????????? ????????? ???
?????? ?????????? ????????????? ?????????, ??
??????????? ???????, ???? ????? ??????????
???????? ??????????? ?????????? ??????????????
?????????? ????????????? ?????????? ?????????????
? ?????????????? ???????????? ??????????
?????????, ??????????? ? (???) ???????????????
???????????? ??? ?? ???? ?????????? ????
?????????? ????????? ? ???????????? ?
?????????????? ??????????? ????????? ??????
???????? ?????????????? ????????? ??? ??????????
??? ?????????
28

• ?????? ????????????? ????????? ???????
  ??????????? ???????????? ? ???????? ????????
  ????????????? ??????? ?????????? ???????????
  ????????? ?? ???????? ???????????????? (???????)
  ?? ??????? ????????? ?????? ??? ?????????
  ???????????? ??????.
• ?????? ????????????? ????????? ??????????
  ???????????????? ???????? (GMP) ??????????? ????
  .
• ??? ??????? ?????????????? ??????? ??????
  ???????????? ????????????? ??????? ??(GMP EC)

29
?? ?????? ???? ???????? ? ????? 2004 ????
??????????? ????????? ?? ?????????????? ?? 458
??? ??????? ???????????? ???????? ???????
???????????? ? ???????? ???????? ?????????????
???????
30
(No Transcript)
31
????? ? ??????????? ???????? ?????????? ??????
? ???????. ????? ?????????? ???????????
??????????? ? ???????????? ?????????? ???
??????????? ??????? ??????????.
32

• ?????????-?????????????????? ??????? ??
  3.3.2.1288-03
• "?????????? ???????? ???????????? ???????????
  ??????????????????? ??????????"
• ???? ???????? 25 ???? 2003 ?.

???????? ???????? ????????????? ????????? ??
???????? ???????????? ????.
??????????? ??? ???????.
???? ??????? ?? ????, ???????? ? ?? ????????
?????.
33
(No Transcript)
34
GUIDE TO GOOD MANUFACTURING PRACTICE FOR
MEDICINAL PRODUCTS

• ????????????? ???????? (Medicinal product)
• ????? ???????? ??? ?????????? ???????,
  ??????????????? ??? ??????? ??? ????????????
  ??????????? ? ????? ??? ????????
• ????? ???????? ??? ?????????? ???????, ???????
  ????? ????????? ????? ??? ???????? ?
  ???????????????? ??????, ? ????? ???
  ??????????????, ????????????? ??? ?????????
  ??????????????? ??????? ????? ??? ????????, ????
  ??????????????? ??? ????????????? ????????.

35

• ??????????? ??????????????????? ????????? (????)
  ????? ???????????????? ??????????? ??
  ????????????? ???????.
• ???????????? ?????? ???? ? ??.
• ?????? ? ???????????? ? ???????????
  ????????????????? ???? ??????? ??????
  ????????????? ???????.

36

• ??????????? ??????????????????? ????????? (????)
• ????????? ??? ???????, ???????????? ?
  ??????????? ???????????? ? ?????? ???????????
  ????????, ??????????????, ? ????????, ?? ?????
  ????????????? ? ?????????????????? ???????.

37

• ?????????? ??????? ?? 3.3.2.015-94
• "???????????? ? ???????? ???????????
  ???????????????????
• ?????????? ??? ??????????? ?? ????????"
• (???. ?????????????? ???????????????????? ?? ??
  12 ??????? 1994 ?.)
• Good ??nufacture Practice

4.13. ??????????? ??????????????????? ?????????
(????). ????????????? ????????, ???????????????
??? ??????????????????, ????????????? ?
??????????? ???????????? ? ??????????????
???????? ? ????????????? ?????????. ??????
??????????? ???????? ???????, ??????????,
????????????, ?????????, ???????????????,
?????????, ??????????????? ?????????, ?????????,
??????????? ?????.
?
38

• ???????? in vitro ??????????? ????????????
  ???????? ? ?? ??????????????? ?? ???????? ???
  ????????????? ????????.

• ?????? ???????? ??? ??????? ?? ?? ??????
  ???????????? ??????, ? ?????? ?? ??????
  ??????????? ?????.

39
??????????? ????? ?? 22 ???? 1998 ?. ? 86-???
????????????? ?????????(? ??????????? ?? 2
?????? 2000 ?., 30 ??????? 2001 ?., 10 ??????
2003 ?.)
????????????? ???????? - ????????, ???????????
??? ????????????, ???????????, ??????? ???????,
?????????????? ????????????, ?????????? ?? ?????,
?????? ?????, ? ????? ???????, ?????? ????????
??? ?????????, ????????, ???????????????,
?????????, ???????? ??????? ??? ? ???????????
????????????? ??????????
40
??????????? ????? ?? 22 ???? 1998 ?. ? 86-???
????????????? ?????????(? ??????????? ?? 2
?????? 2000 ?., 30 ??????? 2001 ?., 10 ??????
2003 ?.)
? ????????????? ????????? ????????? ?????
???????? ?????????????, ????????? ???
?????????????? ?????????????, ??????????
????????????????? ??????????? ? ???????????????
??? ???????????? ? ???????????? ?????????????
???????.
??????????????????? ????????????? ???????? -
????????????? ????????, ??????????????? ???
???????????????? ???????????? ? ????????????????
???????.
41

• ?????????? ???????? ??? 42-510-98
• "??????? ??????????? ???????????? ? ????????
  ???????? ????????????? ??????? (GMP)
• (???. ?????????? ?? 25 ??????? 1998 ?.)
• (?????? ? ???????? ?????????? ???????? ?????????
  ?? ? ???????????? ??
• ?? 3 ??????? 1999 ?. N 432/512)
• (? ??????????? ?? 29 ??????? 2001 ?.)

? ?????????????? ???????? ??????? ?????? ??? ?? ?
??? ?????????? ????. ????????? ????????
???????????????? ?? ??? ?????? ?????????????
???????, ???????????? ?????????? ??????????
"????????? ???????? ????????????? ???????.
???????? ?????????" N 91500.05.001-00.
42

• ?????????? ???????? ??? 91500.05.001.00
• "????????? ???????? ????????????? ???????.
  ???????? ?????????"
• (????????? ???????? ????????? ?? ?? 1 ?????? 2001
  ?. N 388)

??????????????????? ????????????? ???????? -
????????????? ????????, ??????????????? ???
???????????????? ???????????? ? ????????????????
???????.
?????????? 1 ????????????? ?????. ??????? ?
??????????? ???????? ?????? ???????????
??????????????????? ?????????????
??????? ??????????????? ???????????????????
????????????? ???????? - ????????????? ????????,
??????????????? ??? ??????????? ????????????
???????????.
???????????????????
43

• ?????????? ???????? ??? 91500.05.001.00
• "????????? ???????? ????????????? ???????.
  ???????? ?????????"
• (????????? ???????? ????????? ?? ?? 1 ?????? 2001
  ?. N 388)

??????????????????? ????????????? ???????? -
????????????? ????????, ??????????????? ???
???????????????? ???????????? ? ????????????????
???????.
?????????? 2 ???????? ???????? ?????????????
?????? ? ????????????? ?????? ?? ?????????????
???????? ?????????? ??????????? - ??????????????
????????????? XIV. ???????????????????
????????????? ???????? (?????????, ??????????,
??????????, ????????????, ???????,
??????????????? (????????), ????????????????,
??????????????? ?????????) ???????????????
????????? ????-??????? ???????????????? ? ??
?????? ???????????? ?????? ???????
?????????????????? ??????????? ?????
44
??????????????? ???????? ????????????? ??????????
?? ???? ???????? ????? ?????????? ??? ? ???????
??????? ?????????? ???????? ?? ???????
???????. ????????? ?? ? ?????????? ?????
?????????????? ?? ?????????? ?????????.
45
ArrayTube System
46
(No Transcript)
47
????????????? ????????????? ??????????????
???????????????? ??????? ????????????????? 90
???????? ? ???????
48
(No Transcript)
49
????????? ??? in vitro ??????????? ??????????
????????? ?? ????????????? ??????? ?
????????????? ? ???????????? ? ?????????????
????????? ??? ??????????? ???????. ??? ?????
????? ????? ???????? ??????? ???????????.
50
? ????? ?????????? ?????????? ????????? ?
??????????? ???????????? ?? ????????.
????? ?????????????? ??? ? ?????????????????
???????? ??????? ?? ???????? ??????????? gt ???? gt
??????????? gt ???? gt ???????????. ??? ????
????????? ????????? ???????????? ? ???
???????????, ? ????????? ???????? ?????????
????? ????????????? ? ?????? ?/???
????????????. (???? ?? ?????? ?????????
?????????? ? ???? ??????????, ????????????? ???
????????.)
51
?????????? ? ??????? ?????????? ??? ? ?????????
????? ????????? ? ????? ??????????????, ?
?????????? ?????? ??? ????? ??????????? ??
???????? ??????????? gt ???? gt ??????????? gt ????
gt ??????????? ?? ???? ???. ????? ??????????????
???????????? ?????????? ???????????? ??? ??
???????? ????????????. ??? ????????????? ???
????? ????????? ??????? ??????????? gt ???? gt
??????????? gt ???? gt ??????????? ???????????.
52

• ????????????? ?????? ??????? ??????????? ?? ?
  ???? ????.
• ????? ??. ?.?. ?????????? ??????? ???????
  ????????????-?????????? ?????? ???????????????
  ?????? (notified body) ?? ???????? ????????
  ??????? in vitro ??????????? ????????????
  ????????, ??? ?????? ? ????? ?????????????????
  ???????? ????? ????????????? ????????? in vitro
  ??????????? ?? ????? ???????? ?????.

53

• ??????????? ???????????? ? ???????????? ?
  ?????????????? ???????????
• ???????? ?????????????????? ???????????? ???????
  ??????????? (?????? ????????????) ??
• ???????????? ??????????? ?????? ?????????
  ??????????? ??????? ? ??????????? ??
• ??????????? ?????????????? ?? ?????? ???? ???????
  ??? ????????? ????????????

54
???????????

• ????????? ??????????????? ????????? ?????????????
  ?????????? ?? ????????? ????????????? ???????
• ???????? ????? ??????????? ?? ?? ???????????????
  ????????? ????????????? ??????????
• ???????? ????????? ???????? ????? ???????????
  ??????????? ? ???????????? ?????????? ? ?????
  ??????????? ????????? ?????? ???? ???????????
  ??????? ????????????? ??????????? ????????? ??
  ??????? ??? ?????????????? ???????? ????????????.