Malaysian business licence·Federal
Establishment License (EL)
Issued by Ministry of HealthMedical Devices Act 2012 (Act 737); Medical Devices Regulations 2012
Overview
The Establishment License (EL) is required for businesses involved in placing medical devices on the Malaysian market. It ensures compliance with licensing requirements under the Medical Devices Act 2012 and its regulations. This license is essential for manufacturers, authorized representatives, importers, and distributors of medical devices.
Key details
Governing Act
Medical Devices Act 2012 (Act 737); Medical Devices Regulations 2012
Agency fees
RM 250 processing + RM 2000-4000 annual
Validity
3 years
Issuing authority
Ministry of Health
Fees shown are government / local-authority fees payable to the issuing agency. Emerhub charges a separate service fee for handling the application end-to-end.
Eligible applicants
Manufacturers, authorized representatives, importers, distributors
Application requirements
- Refer to: https://www.mda.gov.my/announcement/1093-syarat-syarat-lesen-terkini.html
- For inquiries, contact: Medical Device Authority (MDA), Ministry of Health Malaysia, Level 6, Prima 9, Prima Avenue II, Block 3547, Persiaran APEC, 63000 Cyberjaya, Selangor, MALAYSIA, +603 - 8230 0300, +603 - 8230 0200, mdb@mda.gov.my
Agency fee breakdown
Application Fee for New License: RM250
New License Fee:
- Manufacturer: RM4000
- Authorized Representative: RM4000
- Importer: RM2000
- Distributor: RM2000
Validity: 3 Years
Renewal Application Fee: RM200
Renewal License Fee:
- Manufacturer: RM2000
- Authorized Representative: RM2000
- Importer: RM1000
- Distributor: RM1000
Validity: 3 Years
These are amounts payable to Ministry of Health. Emerhub's service fee is quoted separately when you engage us.