How to Apply for Renewal of Establishment Licence
Introduction
The requirement for renewal of establishment licence is mentioned under the Section 24 of the Medical Device Act 2012 (Act 737). A licensee may apply for renewal of its establishment licence to the Authority not later than one year before the expiry date of the establishment licence.
However, Licensee(s) are required to perform re-certification audit and GDPMD/ISO 13485 certificate must be valid on the expiry date of current licence.
Application
Application for renewal of establishment licence can be made via MeDC@St 2.0
Process Flow for Submitting Renewal of Establishment Licence:- MeDC@St 2.0
Application and Renewal fee
Fees for renewal of licence
|
Type of licence |
Application Fee (RM) |
Renewal Fee (RM) |
|
Manufacturer |
200 |
2,000.00 |
|
Authorised Representative (AR) |
200 |
2,000.00 |
|
Importer |
200 |
1,000.00 |
|
Distributor |
200 |
1,000.00 |
Fees for renewal of multiple licences
|
Type of licence |
Application Fee (RM) |
Renewal Fee (RM) |
|
Manufacturer + distributor |
200 |
2,000.00 |
|
Manufacturer + AR |
200 |
4,000.00 |
|
AR + Distributor + Importer |
200 |
2,000.00 |
|
Importer + Distributor |
200 |
1,000.00 |
List of User Manual
|
No |
Title |
Download |
|
1. |
User Manual for Renewal of Establishment Licence Application |
|
|
2. |
User Manual Video for Renewal of Establishment Licence Application |
|
