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Electrical Equipment (ST/SIRIM) and Medical Device (MDA) Approval

Overview

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.

What we do?

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

Our Job Scopes

Consultation
Advice on preparation of documents in checklist provided.
Submission
Compile and submit documents to Suruhanjaya Tenaga / Medical Device Authority / SIRIM.
Approval
Assist client in any reasonable manner in order to get approval of the registered product/license.

Getting Started

For detailed information on how we assist you, please contact us now to obtain a free consultation session.
ABOUT USBio Prestige
Bio Prestige Advisory is a leading advisory firm founded 10 years ago, specializing in regulatory submission for food supplements, skincare, and pharmaceutical products, KKLIU (Kementerian Kesihatan Lembaga Iklan Ubat), Hologram of Health Supplements and related industries in South East Asia in a responsible and cost-effective manner.
ABOUT US Bio Prestige
Bio Prestige Advisory is a leading advisory firm founded 10 years ago, specializing in regulatory submission for food supplements, skincare, and pharmaceutical products, KKLIU (Kementerian Kesihatan Lembaga Iklan Ubat), Hologram of Health Supplements and related industries in South East Asia in a responsible and cost-effective manner.
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Copyright by Bio Prestige. All rights reserved.

Copyright by Bio Prestige (001917919-A). All rights reserved.