WTO Quantitative Restrictions

Malaysia #9143 (v.3)

Base data

Notified in
Version validity
31/12/2025 - present
Current active version v.3
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.

The Medical Device Act 2012 [Act 737] can be accessed here:
https://portal.mda.gov.my/index.php/documents/regulation/685-medical-device-act-2012-eng/file

Responsible entities
Ministry of Health
HS version
HS 2022
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...
3002
3002
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3003
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3004
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3005
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3006
3006
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3307
3307
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3407
3407
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3808
3808
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3821
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3822
3822
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3926
3926
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
4014
4014
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
4015
4015
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
4823
4823
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
6115
6115
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
6211
6211
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
6212
6212
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
6307
6307
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
8414
8414
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]