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List of User Manual and Guidance Document

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1.

User Manual:

i.Establishment Licence Application

ii.Renewal of Establishment Licence Application

iii. Amendment Major/Minor Application

iv. Withdrawal Application

 

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

2.

User Manual for Change Of Ownership Application

 

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

3.

User Manual Video of Establishment Licence Application

 

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

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

4.

User Manual Video for Renewal of Establishment Licence Application

 

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

5.

User Manual Video of  Amendment Major/Minor Application

 

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

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

6.

User Manual Video of Withdrawal Application

 

https://www.youtube.com/watch?v=ZgmdwGukzW4

7.

User Manual Video of Change Of Ownership Application

 

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

8.

Guidance Document of Licensing for Establishment

 

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

9.

Guidance Document for Good Distribution Practice for Medical Devices (GDPMD)

 

https://www.mdb.gov.my/mdb/index2.php?option=com_docman&task=doc_view&gid=817&Itemid=59

10.

Guidance Document for Change Of Ownership Application

 

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