Malaisie #9144 (v.1)
Données de base
- Notifiée dans
-
G/MA/QR/N/MYS/2 11/10/2023
- 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 of medical device for the purpose of:
• Demonstration for marketing
• Education
• Clinical research of performance evaluation of medical device
• Custom-made medical device
• Special access medical device
- Base légale nationale
-
Medical Device Act 2012 [Act 737]
Medical Device (Exemption) Order 2016
- Mécanisme administratif
-
Administered by Ministry of Health (MOH)
Medical Device (Exemption) Order 2016 states that Minister exempts medical device from Section 5 of the Medical Device Act 2012 [Act 737] if the medical device is:
• for the purpose of personal use;
• for the purpose of demonstration for marketing;
• for the purpose of education;
• for the purpose of clinical research of performance evaluation of medical device;
• a custom-made medical device; or
• a special access medical device.
However, a notification in writing to import these medical devices shall be submitted to the Authority.
- 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
| Cote |
|---|
|
NAL
|
Lignes tarifaires
|
00
|
N/A
|
"Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
|
|
|
252020
|
2520.20.1000
2520.20.9000 |
"Medical device as defined in Section 2 of the Medical Device Act 2012 [Act 737]
"Medical device... |
|
|
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]
|
|