The Medical Device Act 2012 (Act 737) came into effect on 30th June 2013. As part of this, the implementation will enter a transition period of one year for establishment licensing and two years for medical device registration. During this time, the Medical Device Authority (MDA), Ministry of Health is working to ensure that there is clarity on requirements for industry players, as well as to get their feedback on a number of specific details and policies.

MDA is working with Frost & Sullivan Malaysia to undertake study and analysis around the following issues:

• Single or multiple Authorised Representative (AR) to represent medical device manufacturer operating outside Malaysia;
• Licensing of establishment (local manufacturer, AR, importer and distributor) who carries out multiple roles; and
• Registration of medical device that have been approved by regulatory authorities recognised by MDA

As Frost & Sullivan Malaysia is conducting discussions with relevant companies and organisations in the Malaysian medical devices sector, some of the respondent may be contacted for their views and opinions on the issues outlined.
If you have any queries regarding the study or wish to participate by providing your input/feedback, please write to [email protected] with your contact details (name, organisation, telephone, fax and email address).