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