It has come to the attention of the Medical Device Control Division,Ministry of Health Malaysia (MDCD) that there are certain people/companies claiming to offer consultancy and “guaranteed” certificationfor Regulatory Requirement Good Distribution Practice Medical Device(GDPMD), Medical Device Registration, certification to GDPMDS (othercountry’s Good Distribution Practice which is unrelated to MalaysianGDPMD) or ISO 9001 certification as per similar to Malaysian GDPMD,which are claimed to be “in compliance with” the Malaysian Medical Device Act 2012 (Act 737).

Please note that no subsidiary legislation has been gazetted yet byMDCD, and no conformity assessment body has been approved.MDCD wishes to alert the public and medical device industry in Malaysiathat MDCD does not recognize, endorse or approve in any way suchmisleading claims, which (among other things) constitute an offence under the Trade Descriptions Act 2011. It is also a serious offence for any person who makes, orally or in writing signs or furnishes any declaration, return, certificate or other document or information which is
untrue, inaccurate or misleading under Act 737. MDCD would also like to warn the medical device industry that we do not condone such actions.

Any persons who come to know of these misleading and deceptive claims can lodge a complaint to MDCD or to the Ministry of Domestic
Trade, Co-operatives and Consumerism http://www.kpdnkk.gov.my forfalse claims and declarations.Thank you.

Source: MDCD