Jawatan Kosong MDB - Subsequent to the Cabinet decision, Medical Devices Bureau (MDB) was established in September 2005 to develop and implement medical devices regulatory program in Malaysia. A total of 22 posts (16 professional and 6 support staffs) were assigned to the Bureau. Currently 7 professional posts and 6 support staffs have been filled.
ACTIVITIES AND ACHIEVEMENTS
Promulgation of Medical Devices Legislations – A draft of Medical Device Bill has been completed and submitted to the Attorney General’s Department in July 2006. The draft Bill is scheduled to be tabled in Parliament in May 2008 and is expected to be passed by the Parliament by the end of 2008. The preparation of the relevant subsidiary legislations has also been initiated. The first draft of Medical Devices (Pre-market) Regulation has also been completed.
Development of Standards – The development of the medical device regulatory program is guided by the global harmonization trend which encourages convergence in standards and regulatory practices as a means to promote technological innovation and to gain access in the global market. Development of standards pertaining to medical devices is undertaken in collaboration with SIRIM. By the end of 2007, more than international standards pertaining to various aspects of medical devices have been adopted as Malaysian Standards. More standards which are relevant to medical devices will be developed in the future.
Development of Guidance Documents – A set of guidance documents dealing with various aspects of medical device regulatory control has been prepared to provide a set of references and elucidate various aspects of the regulation. It contains 24 sections which include details on classification, essential principles of safety and performance, risk management, labeling and packaging, conformity assessment, nomenclature, quality management system, clinical evidence, recall, incident investigation and adverse event reporting, effective operation and maintenance management as well as disposal.
Voluntary Registration Scheme – As an initial step of a mandatory regulatory environment, a voluntary registration scheme called the Voluntary Registration Scheme for Establishments Dealing with Medical Devices (MeDVER) was launched in early 2006. It was introduced to familiarize all the affected parties with the registration process and to prepare a smooth transition into the full enforcement of medical device regulation. MeDVER will continue until the draft Bill is approved by Parliament. Registration in MeDVER is done on-line and by the end of 2007, a total of 554 establishments have voluntarily registered with MeDVER. Of those who have registered, 80% are distributors and importers, 10% exporters and 5% manufacturers of medical devices whilst the remaining 5% were doing other types of business related to medical devices. More than 4,000 medical devices have also been listed in MeDVER. In 2008, a Voluntary Registration Scheme for Conformity Assessment Bodies (CAB) will be developed to register all CABs operating or plan to operate in Malaysia.
International Relations and Industry Assistance – The Government recognizes the contribution of the medical device industry to the economic growth and actively facilitates local manufacturers to position themselves in the global arena. One of the identified strategies is the adoption of a harmonized system for the placement of medical devices into the global market. In this respect, Malaysia plays the lead role in the ASEAN as well as Asian regions to spearhead the development of a harmonized system for the placement of medical devices into the ASEAN and Asian markets. This includes the development of the common submission dossier template for medical devices market approval and formalization of a post-market alert system for ASEAN and Asia. Medical Device Bureau is also involved in bilateral and multilateral negotiations with other countries, such as US and Australia to facilitate Malaysian medical device industry to gain and broaden their global market access.
Surveillance/monitoring – Surveillance and monitoring activities are carried out to identify medical devices that have problems on the market so that appropriate action can be taken to prevent any adverse incident that may cause public health and safety problem. This is done by screening and gathering saftey information from medical device authorities in other countries. The post-market survellance system will be improved by intoducing an on-line system to further enhance its effectiveness.
Qualified Malaysian citizens invited to fill the vacancies at Kementerian Kesihatan Malaysia as follows :
