Malaysia #9143 (v.1)

Base data

Notified in
Version validity
11/10/2022 - 24/10/2023
Old version v.1
Reporting member
Malaysia
In force from
End date
In force
General description
Non-automatic licensing for the import and export of medical devices
National legal basis
Medical Device Act 2012 [Act 737]

Medical Device Regulation 2012
Administrative mechanism
Administered by Ministry of Health (MOH)

Section 15 of the Medical Device Act 2012 [Act 737] requires all establishment to obtain establishment license in order to import, export or place any medical device in the market

Section 5 of the Medical Device Act 2012 [Act 737] requires all medical device to be registered before it can be imported, exported or placed in the market
Responsible entities
Ministry of Health
HS version
HS 2017
Referenced WTO document symbol

Meta data

WTO justifications

XX:(b) - (b) necessary to protect human, animal or plant life or health;

GATT 1994 (GATT 1947 provisions)

Reported as: Article XX(b) of the GATT
Non-WTO commitments
Affected partners
Non-affected partners

Measures

Reported restrictions
NAL, NAL-X
Symbol
NAL
NAL-X

Tariff lines

252020
2520.20.1000
2520.20.9000
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
Medical device as...
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]