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How to Apply for Establishment Licence

Introduction

  • Section 15(1) of Medical Device Act 2012 (Act 737) requires an establishment to apply for a licence under the Act before it can import, export or place in the market any registered medical device. For that purpose, an application for an establishment licence shall be made according to the requirements and in the manner determined by the Authority in Act 737 and its subsidiary legislations.
  • Starting from 1 July 2013 when Act 737 comes into effect, all establishments dealing with medical devices shall apply for establishment licence under the Act. As provided for by Section 80 of Act 737, any person who has been importing, exporting or placing a medical device in the market prior to the effective date of the Act and intends to continue to carry out his activities shall, apply for an establishment licence under this Act within 12 months from the effective date.

Application

Application for establishment licence can be made via MeDC@St 2.0 

What is an Establishment?

An establishment can either be a manufacturer, an Authorized Representative, AR (of a Foreign Manufacturer), an importer or a distributor of medical device. The complete definition of term “establishment” is given in Section 2 of Act 737. OEM or tendering agent is not defined as establishment.

Figure 1 shows flow-chart of the steps to be taken by an applicant before making an application for an establishment licence under Act 737.

 figure1

Figure 1: Steps to be taken before making an application for an establishment licence

 

How Long Is The Licence Validity And When We Can Start To Renew?

The validity of the establishment licence is 3 years and an establishment can start to renew the licence 1 year prior to expiry date.

 

Are We Allowed To Run Multiple Activities Under A Single Licence?

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.

Process Flow for Submitting Establishment Licence Application:-

figure2

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

List of User Manual

No

Title

Download

1.

User Manual of Establishment Licence Application

 

https://docs.google.com/document/d/13yBI46CAtSzICy9QllzBM_xafuuBBZBz1eFwUTt77dY/edit

2.

User Manual Video of Establishment Licence Application

 

https://www.youtube.com/watch?v=eQ6HtfI3Yu8

https://www.youtube.com/watch?v=_s8RiyzitOQ

 

 

 

Print

  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