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How To Apply For Change Of Ownership Application

Introduction

A request to change of ownership for medical device registration shall be made after the medical device is registered with the Authority and there shall be no pending applications in the system.

Otherwise, the applications would be required to be completed or withdrawn. The application for change of ownership for medical device registration shall be made by the new AR, and only duly completed application forms shall be submitted to the Authority.

Change ownership of medical device registration is required for reasons such as:

  1. a) Manufacturer outside Malaysia who has set up a company in Malaysia and intends to obtain the ownership of medical device registration from AR.
  2. b) Replacing of existing AR to new AR by the manufacturer to place the medical device in the market
  3. c) Merging and acquisition activities
  4. d) Existing AR closed its business

Application :

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

The Fee

The new AR will be required to pay the service/processing fee RM 500 per medical device registration ID

List of User Manual/Guidance Document

No

Title

Download

 

1.

User Manual for Change Of Ownership Application

 

https://docs.google.com/document/d/1z7k632hEGvNxjaxVGU-nTtTKCiIZR3sBGIaMjUmPYrg/edit

2.

User Manual Video for Change Of Ownership Application

 

https://www.youtube.com/watch?v=VONZPKaDu5Q

3.

Guidance Document for Change Of Ownership Application

 

https://mdb.gov.my/mdb/index2.php?option=com_docman&task=doc_view&gid=816&Itemid=59

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