WTO Quantitative Restrictions

Malaysia #9144 (v.3)

Base data

Notified in
Version validity
31/12/2025 - present
Current active version v.3
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:
• Personal use;
• Demonstration for marketing;
• Education;
• Clinical research;
• Performance evaluation of medical device;
• Export only;
• Import for re-export;
• Custom-made medical device
• Special access medical device
• Orphaned medical device;
• Obsolete medical device; or
• Discontinued 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 2024 states that Minister exempts medical device from Section 5 of the Medical Device Act 2012 [Act 737] if the medical device is:
• for the purposes of personal use;
• for the purposes of demonstration for marketing;
• for the purposes of education;
• for the purposes of clinical research;
• for the purposes of performance evaluation of medical device;
• for the purposes of export only;
• for the purposes of import for re-export;
• a custom-made medical device;
• a special access medical device;
• an orphaned medical device;
• an obsolete medical device; or
• a discontinued medical device.

However, an exemption application in writing to import these medical devices shall be submitted to the Authority.

The Medical Device (Exemption) Order 2024 can be accessed here:
https://portal.mda.gov.my/index.php/doclink/p-u-a-78-2024-perintah-peranti-perubatan-pengecualian-2024-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJwLXUtYS03OC0yMDI0LXBlcmludGFoLXBlcmFudGktcGVydWJhdGFuLXBlbmdlY3VhbGlhbi0yMDI0LXBkZiIsImlhdCI6MTcwOTc5NjE2MSwiZXhwIjoxNzA5ODgyNTYxfQ.f_9g6uHXSX2VcX9HHFcWOp_RL7mixU9Fhfosya_8Fq8

Responsible entities
Ministry of Health
HS version
HS 2022
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]