9/19/02. The phone and fax numbers for the Ministry of Health
contacts have changed; the Atomic Energy Licensing Board's contact
info is also changed.
Disclaimer: The information contained on this website is derived from public sources and is current to the best of our knowledge. For detailed and definitive information about a country's laws and policies, the government of the country concerned should be consulted.
There are no Malaysian government requirements for general registration of medical devices. While the Malaysian government has indicated during the late 1990s that it will move toward some certification system based on specific product standards, no such regulations to this effect have yet been adopted, as of 9/15/02. Documentation of USFDA (Certificate for Foreign Government or "CFG"), CE mark or other international approval must accompany imported devices regarded as experimental in their country of origin. However, while there is otherwise no general governmental requirement for documentation of medical device approval by the country of origin, a USFDA Certificate for Foreign Government (or European CE mark) is often sought by Malaysian end-users or buyers of even non-experimental devices as assurance of safety / effectiveness.
Radiation-emitting devices: Import into Malaysia of any apparatus based on the use of X-rays, or otherwise irradiating devices, whether or not for medical, surgical dental or veterinary uses, does require a permit issued by Malaysia's Atomic Energy Licensing Board (see "contacts" below).
Practical restrictions on sales to government buyers: While not subject to general registration, higher-technology capital medical equipment purchased for use in public hospitals and institutions is subject to standards-based evaluation by the Health Ministry's Health Technology Assessment Unit prior to purchase. In addition, while pre-owned medical equipment is not barred to private purchasers, Malaysian government policy is not to buy used or refurbished medical equipment.
Imported medical equipment is duty-free. Importers of medical equipment, like all importers into Malaysia, are required to fill out the customs declaration form, as part of normal customs procedure.
of Health of Malaysia (main offices)
of Health - Procurement and Privatization Division
Energy Licensing Board
Information on licensing requirements for radiation-emitting devices can be obtained by following the "Licensing" link at the Board's website, http://www.aelb.gov.my/web2000/english/text/Indexe_licen.htm.
Additional information about the Malaysian healthcare sector can be found on http://www.export.gov and doing a search under Country and Market Research.
Appendix 1: For more information, read the following 2005 Commercial Service Reports.
Last updated on 7-1-08 by TH
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