FDAnews
www.fdanews.com/articles/11193-malaysias-mda-addresses-authorized-representatives

Malaysia’s MDA Addresses Authorized Representatives

February 3, 2017

Every medical device imported into Malaysia for sale must have a single authorized representative, according to a new circular from the country’s Medical Device Authority.

An authorized representative is a Malaysian resident or a firm incorporated there, provided the representative or firm carries on its business principally in Malaysia.

The representative’s role is to help foreign manufacturers comply with Malaysian medical device regulations.

Foreign manufacturers that sell more than one device in Malaysia may appoint more than one representative.

Read the circular here: www.fdanews.com/01-27-17-Registration.pdf.