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Medical Device Regulatory
Requirements for
Malaysia

Updated: 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.

Contacts:

Ministry of Health of Malaysia (main offices)
Block D
Jalan Cenderasari
50590 Kuala Lumpur
Tel: 60-3-2698-5077
Fax: 60-3-2693-1208

Ministry of Health - Procurement and Privatization Division
8th Floor, Perkim Building
Jalan Ipoh, 51200 Kuala Lumpur, Malaysia
Tel: 60-3-4045-7001
Fax: 60-3-4045-7237

Atomic Energy Licensing Board
The Atomic Energy Licensing Board has recently been relocated to a new area. They do not have a telephone contact at present. Any inquiries should be forwarded to the Ministry of Science Technology & Environment (Tel: 60-3-8885-8000).

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.

Malaysia's New Biotech Policy

Malaysia Cancer Diagnostic and Therapy Equipment


Last updated on 7-1-08 by TH

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