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FDA UDI規制の概要(流開センター 黒澤) - dsri.jp

FDA .. (1) IMDRF . GHTF( IMDRF . International Medical Device Regulatory Forum) 2011 4 .. (2) FDA . IMDRF FDA 2013 9 . 2014 9 . (3) . (EC) . 2012 9 UDI. 2013 4 EU (2013 172 EU) . UDI 2015 UDI . 2018 UDI . IMDRF FDA .. FDA . FDA . FDA .. FDA 2015 . 1.. 2013 11 2015 1 .. 20 .. FDA .. EFPIA . 2013 .. 2013 11 27 . 2015 1 1 .. 2015 7 1 . 2016 . 2017 11 27 NDC . 2018 11 27 NDC . 2019 11 27 . 2020 11 27 . 2023 11 27 ( ) . FDA . FDA ..UDI . (Unique Device Identification) UDI .. FDA . 2.. UDI UDI FDA UDI . 3 UDI . UDI . ( . ) GS1 HIBCC : Health Industry Business Communications Council ICCBBA( . International Council for Commonality in Blood Banking Automation).

4 ル番号を表示する場合もある。 ③udiを適用する方法 udiはリコール時の機器の特定や迅速正確な回収を実現させるために、医療機器本体及び機器・

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Transcription of FDA UDI規制の概要(流開センター 黒澤) - dsri.jp

1 FDA .. (1) IMDRF . GHTF( IMDRF . International Medical Device Regulatory Forum) 2011 4 .. (2) FDA . IMDRF FDA 2013 9 . 2014 9 . (3) . (EC) . 2012 9 UDI. 2013 4 EU (2013 172 EU) . UDI 2015 UDI . 2018 UDI . IMDRF FDA .. FDA . FDA . FDA .. FDA 2015 . 1.. 2013 11 2015 1 .. 20 .. FDA .. EFPIA . 2013 .. 2013 11 27 . 2015 1 1 .. 2015 7 1 . 2016 . 2017 11 27 NDC . 2018 11 27 NDC . 2019 11 27 . 2020 11 27 . 2023 11 27 ( ) . FDA . FDA ..UDI . (Unique Device Identification) UDI .. FDA . 2.. UDI UDI FDA UDI . 3 UDI . UDI . ( . ) GS1 HIBCC : Health Industry Business Communications Council ICCBBA( . International Council for Commonality in Blood Banking Automation).

2 ( 20 3 28 . 0328001 ) GS1 GS1. 100 . 0 . 1. 2.. GTIN GS 9 . ( ). 3 .. FDA . 2 (= ) . (= ) (= . ) (= ) .. (Device Identifier DI) .. ( ) . (Production Identifier PI) .. GS1-128 GS1-128 . ( . ) . 3.. UDI . UDI .. GS1-128 2 . FDA . FDA .. FDA UDI . GUDID .. Web FDA HL7 HL7 . Health Level Seven ISO-OSI 7 . GDSN(Global Data Synchronaization Network ) 3 .. 4. UDI . UDI 2014 5 2011. 9 GHTF UDI 2012 2 GHTF. IMDRF UDI 2012 7 FDA UDI . 2013 4 UDI. 2013 9 UDI 1 2014 9. UDI . 2015 9 . UDI 2016 9 . UDI . 2018 9 . UDI.. FDA 2018 .. 5. 2013 9 24 UDI . GS1, HIBCC,ICCBBA FDA ( 1 2 3). UDI . 2014 9 24 UDI. ( 1 ) UDI ( 4).. UDI ( 5). 2015 9 24 . ( 2 ) UDI UDI.

3 UDI .. UDI . 2016 9 24 UDI. ( 3 UDI . UDI . UDI . 2018 9 24 UDI. ( 5 ) UDI . UDI .. UDI . 2020 9 24 . ( 7 ) .. UDI .. FDA UDI . ( 1)GS1 112 . 130 . ( 2)HIBCC Health Industry Business Communication Council . 2400 600 3000 . ( 3)ICCBBA: International Council for Commonality in Blood Banking Automation . ( 4) UDI ( GUDID) . ( 5) UDI . (DVD, CD ) UDI . 6. UDI . FDA UDI . (1) . YYYY-MM-DD( 4 2 2 ) ISO . - ( ) 2018-12-31. (2)UDI . UDI ( DI: Device Identifier) ( PI: Production Identifier) . ( DI: Device Identifier) .. ( ) . ( PI: Production Identifier) .. (3) . I ( PI ) . ( DI) ( ) . (4) Direct Marking .. ( ) . = . (5) UDI . UDI . UDI .. (6) UDI.)

4 CD . DVD USB UDI .. 7. (7) UDI . UDI . A,B,C,D UDI . ( ). UDI . A. B. C. D. (8) ( ) UDI . ( ) . UDI ( ) UDI .. / . (9) UDI . ( ) UDI .. ( ). ( ) ( ).. 1 .. FDA UDI / . 8.. (10) UDI . (11) ( ) UDI . ( ) UDI .. UDI . (12) SUD UDI . 3 UDI .. GMDN .. DI & PI . 9.. FDA UDI . GHTF (IMDRF) . UDI . GS1 .. UDI . FDA .. FDA .. 10.


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