QR Malaisie #9143 - OMC Restrictions quantitatives

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Malaisie #9143 (v.3)

Données de base

Notifiée dans: G/MA/QR/N/MYS/4 17/07/2026
Validité de la version: 31/12/2025 - actuelle
Version active v.3
Membre présentant le rapport: Malaisie
En vigueur depuis: 11/10/2022
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.

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
Entités responsables: Ministry of Health
Version du SH: HS 2022
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]