Malaisie #9143 (v.1)

Données de base

Notifiée dans
Validité de la version
11/10/2022 - 24/10/2023
Ancienne version v.1
Membre présentant le rapport
Malaisie
En vigueur depuis
Date de fin
En vigueur
Description générale
Non-automatic licensing for the import and export of medical devices
Base légale nationale
Medical Device Act 2012 [Act 737]

Medical Device Regulation 2012
Mécanisme administratif
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
Entités responsables
Ministry of Health
Version du SH
HS 2017
Cote du document de l'OMC mentionné

Métadonnées

Justifications au regard de l'OMC

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

GATT 1994 (GATT 1947 provisions)

Signalé comme: Article XX(b) of the GATT
Engagements internationaux (hors OMC)
Partenaires concernés
Partenaires non concernés

Mesures

Restrictions signalées
NAL, NAL-X
Cote
NAL
NAL-X

Lignes tarifaires

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