PRESS STATEMENT ON THE IMPLEMENTATION OF THE MEDICAL DEVICES ACT

In reference to the front page news article in The Sun dated 29th October 2014 titled “Stop It”, and letter to the editor in The News Straits Times dated 12th November 2014 titled “Health Ministry playing dice with our lives”, the Medical Device Authority would like to make the following clarifications:

i. The Medical Devices Act (2012) is intended to regulate medical device and its industry. The Act requires all establishments, which include manufacturers, authorised representatives, distributors and exporters to be licensed before they are allowed to do business in the medical device industry in the country.

ii. Furthermore, all medical devices are required to be registered with the Medical Device Authority (MDA) before they can be placed in the Malaysian market.

iii. The Act also provides provisions on the transition period to assist the industry. This is to ensure continuous accessibility of medical device for public use during the initial stage of implementation of the Act.

iiii. For the registration of medical devices, a grace period of 24 months from the 1st July 2013 is given to establishments who have previously imported, exported or placed medical devices in the market to continue to do so.

v. As in the case of licensing of establishments, a grace period of 12 months is given to these establishments from the 1st July 2013. These establishments may continue to import, export or place medical devices in the market pending determination of their application for an establishment license.

Saving lives has always been the top priority and important professional responsibility of all healthcare personnel and also the Ministry. Hence, the safety and medical care of all patients must always be in accordance with the highest ethical standards.

DATUK DR. NOOR HISHAM BIN ABDULLAH
Chairman of Medical Device Authority
Director General of Health Malaysia
Ministry of Health Malaysia
12th November 2014

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