Malasia #9143 (v.3)
Datos básicos
- Notificada en
-
G/MA/QR/N/MYS/4 17/07/2026
- Validez de la versión
-
31/12/2025 -
actual
Versión activa actual v.3
- Miembro informante
- Malasia
- En vigor desde
- Fecha de supresión
- En vigor
- Descripción general
-
Non-automatic licensing for the import and export of medical devices
- Fundamento jurídico nacional
-
Medical Device Act 2012 [Act 737]
Medical Device Regulation 2012 - Mecanismo administrativo
-
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
- Entidades responsables
-
Ministry of Health
- Versión del SA
-
HS 2022
- Signatura de la OMC a que se hace referencia
Metadatos
- Justificaciones en el marco de la OMC
-
XX:(b) - (b) necessary to protect human, animal or plant life or health;
GATT 1994 (GATT 1947 provisions)
Notificada como: Article XX(b) of the GATT - Compromisos Internacionales (distintos de los asumidos en el marco de la OMC)
-
- Interlocutores afectados
- Interlocutores no afectados
Medidas
- Restricciones notificadas
- NAL, NAL-X
| Signatura |
|---|
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NAL
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NAL-X
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Líneas arancelarias
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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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3002
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3002
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3003
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3003
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3004
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3004
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3005
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3005
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3006
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3006
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3307
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3307
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3407
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3407
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3808
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3808
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3821
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3821
|
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
|
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3822
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3822
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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3926
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3926
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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4014
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4014
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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4015
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4015
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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4823
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4823
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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6115
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6115
|
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
|
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6211
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6211
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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6212
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6212
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Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
|
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6307
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6307
|
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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8414
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8414
|
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
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