Malasia #9143 (v.1)

Datos básicos

Notificada en
Validez de la versión
11/10/2022 - 24/10/2023
Versión anterior v.1
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
Entidades responsables
Ministry of Health
Versión del SA
HS 2017
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
NAL
NAL-X

Líneas arancelarias

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]
3003
3003
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3004
3004
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
3005
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]
3821
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]
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8414
Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]