September 4th, 2017

          Malaysia’s MDA published a new regulation on 25^th July, 2017. From the publication, there are two significant changes:

            1. Starting from January 1, 2018, the manufactures can only import the medical device which already have MDA certification.

            2. Applicants who already submitted their application to MDA would need to complete the documents requested by MDA before October 31, 2017, and acquire the MDA certification before December 31, 2017. If not, their acknowledgment letters will be invalidated.

      In the past, medical device registration is not mandatory in Malaysia, so manufacturers can directly import the medical device without getting medical device licenses. It was only in 2013 that MDA published the regulation of medical device registration and issued acknowledgment letters to the applicants submitting their registration application until June 30^th, 2016. Using the acknowledgement letters, manufacturers were able to maintain their commercial activities in the country.

The market will adapt eventually to the new regulations.

 

Reference:

FULL ENFORCEMENT OF REGISTRATION REQUIREMENTS of MEDICAL DEVICES UNDER SECTION 5 MEDICAL DEVICE ACT 2012 (ACT 737)