ANNOUNCEMENT: IMPLEMENTATION OF MEDICAL DEVICE IMPORT PERMIT

MEDICAL DEVICE AUTHORITY

ANNOUNCEMENT: IMPLEMENTATION OF MEDICAL DEVICE IMPORT PERMIT

Dear Valued Clients,

The Medical Device Authority (MDA) serves as the designated Other Government Agency (OGA) responsible for issuing Import Permits (IP) for the importation of medical devices. The importation of medical devices is subject to import permit under the Customs (Prohibition of Import) Order 2023.

To support the implementation of this import permit, the MDA has taken the following measures:

✅Inclusion of medical device tariff codes in the Customs (Prohibition of Import) Order 2023;

✅Development of an ePermit System to facilitate import permit applications for medical devices and verification slip applications for non-medical devices that fall under medical device tariff codes; and

✅Preparation of guidelines and a user manual to assist importers in the application process for medical device import permit.

Procedure

Application for an import permit must be submitted through the online permit system (ePermit: http://newepermit.dagangnet.com). Applications may be submitted to the Authority at least 7 days prior to shipment of medical devices. Import permits will be processed within 3 working days from the application date.

For urgent shipments (e.g. overnight shipments by road from Singapore/Thailand or temperature-sensitive goods), the Authority may expedite processing to within 24 hours upon confirmation of payment.

The Medical Device Authority (MDA) is gearing up to bring you industry awareness sessions and hands-on training. The schedules of the session are as follows:

Session	Date/Time	Mode	Registration
Import Permit Briefing Session Series 1	27 February 2025/ 10.00 am - 12.00 pm	Physical	Form(Limited to 50 pax)-CLOSE
Import Permit Briefing Session Series 2	13 March 2025/ 10.00 am - 12.00 pm	Virtual	Form (Limited to 100 pax)-CLOSE
Import Permit Briefing Session Series 3	16 April 2025/ 10.00 am - 12.00 pm	Virtual	Form (Limited to 100 pax) – Link accessible on 7 April 2025
Hands-on Training ePermit System- Series 1	15 May 2025/ 10.00 am - 4.00 pm	Physical	To be update
Hands-on Training ePermit System- Series 2	9 Jun 2025/ 10.00 am - 4.00 pm	Physical	To be update
Hands-on Training ePermit System- Series 3	9 July 2025/ 10.00 am - 4.00 pm	Physical	To be update
Hands-on Training ePermit System- Series 4	7 August 2025/ 10.00 am - 4.00 pm	Physical	To be update

Processing Fees for Permit

The import permit fee is RM130 per application (applicable for all purposes except for sample investigation purposes)
The verification slip fee is RM50 per application

Reference:

(1) Guideline:

The Guidelines to Apply for a Medical Device Import Permit Under Customs (Prohibition on Imports) Order 2023 are currently in draft

(2) User Manual:

The user manual ePermit System MDA still in draft

(3) List of HS Codes

The identified HS Codes that may be included in the gazettement: PDF Document

Contact details

Mr. Luqman Hafifi :03-8230 0212
Ms. Nur Aisyah: 03-8230 0253
Contact number: 010-3323210 (Whatsapp only)
E-mail: importpermit@mda.gov.my

Updated: 26 March 2025