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MD.PH-1

 December 24, 2018

MD.PH-2

          

MD.PH-3.1

New Regulation (for implementation in 2019):

AO 2018-0002

“Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”

The comparison between the current guidelines and the new guideline are summarized as follows: 

PH RegUpdate

 

   MD.PH-4

 

MD.PH-5

MD Reg Introduction - PH 4MD Reg Introduction - PH 5

 

MD.PH-6

 

MD.PH-7

 

MD.PH-8.2

 

MD.PH-9.2

               PFDA’s official website or you may contact us for a free consultation.

 
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