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Malaysia Medical Device Act 2012 ( Act 737)

Section 2 - INTERPRETATION
"establishment" means -  
a)  a person who is either a manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include a retailer ;  and
b) an authorized representative appointed by manufacturer having a principal place of business outside Malaysia, and such person and authorized representative being :
    ( A ) a person domiciled or resident in Malaysia ; or
    ( B ) a firm or company constituted under the laws of Malaysia, and carrying on business or practice principally in Malaysia   

"manufacturer" mean –
( a ) a person who is responsible for :
( i ) the design, production, fabrication, assembly, processing, packaging and labelling of a medical device whether or not it is the person, or a subcontractor acting on the person’s behalf, who carries out these operations ;
AND
( ii ) assigning  to the finish medical device under his own name, its intended purpose and ensuring the finish product meets the regulatory requirement ; or

( b ) any other person who :
( i ) assembles, packages, processes, fully refurbishes, reprocesses or labels one or more ready - made medical devices ; and
( ii ) assigning to the ready - made  medical device under his own name, its intended purpose and ensuring the finished product meets the regulatory requirement.

Requirement on Quality Management System
Type of Establisement Quality Management System
Manufacturer ISO13485 – Medical Devices – Quality Management System – Requirement for Regulatory Purposes
Authorised Representative Good Distribution Practice for Medical Devices (GDPMD)
Importer Good Distribution Practice for Medical Devices (GDPMD)
Distributor Good Distribution Practice for Medical Devices (GDPMD)





Hrz principal Dec2016