Malaysia #9144 (v.1)
Base data
- Notified in
-
G/MA/QR/N/MYS/2 11/10/2023
- Version validity
-
11/10/2022 -
24/10/2023
Old version v.1
- Reporting member
- Malaysia
- In force from
- End date
- In force
- General description
-
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
- National legal basis
-
Medical Device Act 2012 [Act 737]
Medical Device (Exemption) Order 2016
- Administrative mechanism
-
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.
- Responsible entities
-
Ministry of Health
- HS version
-
HS 2017
- Referenced WTO document symbol
Meta data
- WTO justifications
-
XX:(b) - (b) necessary to protect human, animal or plant life or health;
GATT 1994 (GATT 1947 provisions)
Reported as: Article XX(b) of the GATT - Non-WTO commitments
-
- Affected partners
- Non-affected partners
Measures
- Reported restrictions
- NAL
| Symbol |
|---|
|
NAL
|
Tariff lines
|
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]
|
|