END OF EXEMPTION UNDER MEDICAL DEVICE (EXEMPTION) ORDER 2015

This is to announce that the exemption as specified in Medical Device (Exemption) Order 2015 has reached its end on 30^th Jun 2016. Starting from 1^st July 2016 onwards, Section 5(1) of Act 737 shall be duly enforced. Therefore, as per proviso of Section 5(1) , any activities involving importation, exportation and placement of medical devices in the market can only be resumed once the application is approved and certificate of registration is issued by the Authority.

Any person who contravenes section 5(1) of Act 737 commits an offence and shall, on conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding three years or to both

Kindly be advised that any application made after 1^st July 2016 is required to submit all documents required by the Authority, including certificate and report issued by local registered Conformity Assessment Body prior to approval by the Authority.