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The Suruhanjaya Tenaga (ST) ensures the safety of the public by regulating low voltage electrical equipment that require no special skills and are sold directly to consumers. This is achieved by ensuring that all electrical equipment sold in the market is safe for use and does not pose any harm to the consumers. A Certificate of Approval (CoA) is required for the import, manufacture, display, sale or advertisement of regulated electrical equipment and release letter for non-regulated equipment.
Medical devices refer to a broad range of instruments, apparatus, software, and other articles that are intended by the manufacturer to be used alone or in combination for human beings. In Malaysia, a foreign manufacturer must appoint a local authorized representative, which is a locally registered business entity, to register its medical devices with the Medical Device Authority (MDA) prior to their importation. This ensures that only high-quality medical devices that meet the MDA’s safety standards are imported and made available to the Malaysian people.
Electrical Equipment
1. Certificate of Registration (COR) to Manufacture/ Import application
2. Certificate Of Approval (COA) application
3. Release letter application
4. Sirim label Application
Medical Device
1. GDPMD certification application
2. Establishment license application
3. Medical Device Product Approval