Establishment License
Establishment License
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.
Overview
Certified application by AQCTA will then be submitted to the Medical Device Authority via online registration system called MEDCAST for approval.
Before the registration process of a medical device begin, manufacturer or importer shall have an “establishment license” for them to legally sell the medical device as part of requirements by Medical Device Authority.
Non-local manufacturer shall appoint an Authorised Representative which will be responsible in managing the registration process.
Other Services
- Confomity Assessment
- Establishment license
- GDPMD
- MDQMS
- Online training