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Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT

Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates respectively this week.


LICENSING FOR ESTABLISHMENT

Medical Device Authority (MDA) is seeking input on its plans to revise its guidance on obtaining a license to import, export or place products on the market.


The draft includes additional definitions and new requirements relating to postmarket responsibilities.


This guidance document applies to establishments as defined under Section 2 of the Medical Device Act 2012 (Act 737).


This guidance document covers establishment licensing procedures; licensing for multiple roles; obligations of the establishment; amendment application of establishment license; and renewal of establishment license.


Click on this LINK to know more about the types of licenses, the application process, etc.


UPDATES TO CHANGES TO MANUFACTURING FACILITIES


The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has updated its position on changes to foreign manufacturing facilities and plants making sterile products.


Click on this LINK to know more about the Type III changes to the location of facilities outside of the countr and a simplified description of Type IV changes.


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