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How to Apply for Amendment of Establishment License

Introduction

Amendment of establishment license is divided into two categories which are amendment major and amendment minor. If an establishment intends to amend the details of establishment licence, establishment shall submit the request application via online application Medcast 2.0.

1) Amendment Major

- There are 3 types of amendment major:

1) Change of Establishment Name

2) Change of Establishment Address

2) Change of Person Responsible Name & IC/Passport

 

Process Flow for Submitting Amendment Major Application

figure4

2) Amendment Minor

- There are 5 types of amendment minor:

1) Change of Establishment telephone, fax and company website

2) Change of Contact Person Details

3) Change of Person Responsible Details except Name & IC/Passport

4) Change of QMS Details

5) Additional of Letter of Authorization (LOA)

Process Flow for Submitting Amendment Minor Application:-

figure5

List of User Manual/Guidance Document

No

Title

Download

1.

User Manual of Amendment Major / Minor Application

 

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

2.

User Manual Video

I. Amendment Major

ii. Amendment Minor

 

https://www.youtube.com/watch?v=0KmYsnN9iWM

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

3.

Guidance Document of Licencing For Establishment

 

https://mdb.gov.my/mdb/index2.php?option=com_docman&task=doc_view&gid=813&Itemid=59

 

 

 

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  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