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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:-

 figure3

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

 

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

2.

User Manual Video for Renewal of Establishment Licence Application

 

https://www.youtube.com/watch?v=WM8ZU0-xPbs

 

 

 

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