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MEDICAL DEVICE (EXEMPTION) ORDER 2016
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pdf
1 IVD MEDICAL DEVICE CLASSIFICATION SYSTEM
( pdf, 556 KB )
(20408 muat turun)
Popular
14 Apr 2018
pdf
16 Notification for Clinical Research or Performance evaluation
( pdf, 1.58 MB )
(13027 muat turun)
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14 Apr 2018
pdf
16 Notification for Clinical Research or Performance evaluation
( pdf, 1.58 MB )
(18008 muat turun)
Popular
29 Nov 2021
pdf
18 Notification Demonstration
( pdf, 913 KB )
(7314 muat turun)
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14 Apr 2018
pdf
190220 GDAC 3 Requirement CAB To Publish
( pdf, 1.34 MB )
(15214 muat turun)
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07 Sep 2020
pdf
190220 GDAC 3 Requirement CAB To Publish
( pdf, 1.34 MB )
(16706 muat turun)
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30 Nov 2021
pdf
2 EPSP OF IVD MEDICAL DEVICES
( pdf, 497 KB )
(19919 muat turun)
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14 Apr 2018
pdf
2 EPSP OF IVD MEDICAL DEVICES
( pdf, 499 KB )
(11175 muat turun)
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29 Nov 2021
pdf
20 Change Notification Scope
( pdf, 871 KB )
(5676 muat turun)
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14 Apr 2018
pdf
20191121 GD Notification Demonstration
( pdf, 380 KB )
(19078 muat turun)
Popular
07 Jan 2020
pdf
20191121 GD Notification Demonstration
( pdf, 383 KB )
(2920 muat turun)
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29 Nov 2021
pdf
202012 GD IVD Product Grouping MDAGD0054
( pdf, 1.16 MB )
(3105 muat turun)
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28 Mac 2022
pdf
202012 GD IVD Product Grouping MDAGD0054 (1)
( pdf, 1.81 MB )
(10806 muat turun)
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15 Apr 2021
pdf
202012 GD IVD Product Grouping MDAGD0054 (1)
( pdf, 1.82 MB )
(4172 muat turun)
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30 Nov 2021
pdf
24 Requirement for Export Permit
( pdf, 648 KB )
(7604 muat turun)
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14 Apr 2018
pdf
24 Requirement for Export Permit
( pdf, 651 KB )
(14763 muat turun)
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29 Nov 2021
pdf
25 Declaration of Conformity
( pdf, 478 KB )
(31069 muat turun)
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14 Apr 2018
pdf
25 Declaration of Conformity
( pdf, 480 KB )
(34154 muat turun)
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29 Nov 2021
pdf
26 Requirement on Labelling of MD
( pdf, 608 KB )
(6614 muat turun)
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14 Apr 2018
pdf
27 Licensing for establishment
( pdf, 746 KB )
(43861 muat turun)
Popular
14 Apr 2018
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