All Malaysian establishments, ie manufacturer, authorised representative (AR), importer and distributor must apply for establishment licence. However, only manufacturer and AR need to apply for medical device registration.
The validity of the establishment licence is 3 years and an establishment can start to renew the licence 1 year prior to expiry date.
Based on the Circular No. 1 Year 2014, an establishment as the manufacturer of a medical device may carry out the activities of distributing manufactured medical device under a single licence.
Establishment that serves as the Authorised Representative may distribute and import medical device represented to them under a single licence.
AQC TECHNICAL ASSESSORS (M) SDN. BHD. is approved as a Conformity Assessment Body (CAB) by Medical Device Authority – Ministry of Health Malaysia. Our talented professional provide assessments and verification on Medical Devices General Medical Devices and In vitro Diagnostic medical devices with stringent quality and approvals based on relevant Malaysian regulatory requirements .
Application and Licence Fee
Fees for Establishment Licence (single licence)
Type of licence | Application Fee (RM) | Renewal Fee (RM) |
Manufacturer | 250 | 4000 |
Authorised Representative (AR) | 250 | 4000 |
Importer | 250 | 2000 |
Distributor | 250 | 2000 |
Fees for Establishment Licence (multiple licences)
Type of licence | Application Fee (RM) | Renewal Fee (RM) |
Manufacturer + distributor | 250 | 4000 |
Manufacturer + AR | 250 | 8000 |
AR + Distributor + Importer | 250 | 4000 |
Importer + Distributor | 250 | 2000 |
For further detailed enquiries, do contact us