Malasia #9144 (v.2)
Datos básicos
- Notificada en
-
G/MA/QR/N/MYS/3 24/10/2023
- Validez de la versión
-
24/10/2023 -
actual
Versión activa actual v.2
- Miembro informante
- Malasia
- En vigor desde
- Fecha de supresión
- En vigor
- Descripción general
-
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
- Fundamento jurídico nacional
-
Medical Device Act 2012 [Act 737]
Medical Device (Exemption) Order 2016
- Mecanismo administrativo
-
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.
- 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
| Signatura |
|---|
|
NAL
|
Líneas arancelarias
|
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]
|
|