MCMC Type Approval (For Communications Equipment)

  • What is MCMC Type Approval (also known as SIRIM Type Approval)
    • Malaysian Communications and Multimedia Commission (MCMC) requires type approval for communications equipment sold for use in Malaysia, ensuring it meets technical standards. SIRIM QAS International Sdn Bhd is the sole agency appointed by MCMC to test and certify communications equipment.
    • Non-compliance with SIRIM Type Approval regulations can lead to heavy financial penalties, legal consequences, and business disruption. Ensuring that all communications equipment is properly certified before entering the Malaysian market is crucial to avoid these risks.
  • Who Needs It?
    • Importers and manufacturers of devices such as smartphones, modems, Wi-Fi devices, etc. are required to obtain a Certificate of Conformity (CoC) to market and sell these devices in Malaysia. Companies who do not comply with the MCMC regulations can be fined up to RM 100,000 per offense under the Communications and Multimedia Act 1998 (CMA).
  • Our Services:
    • Product assessment
    • Compliance documentation preparation
    • Submission to SIRIM
    • Liaison with SIRIM until approval
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ST Certificate of Approval (CoA) (For Electrical Equipment)

  • What is ST CoA?
    • Suruhanjaya Tenaga (ST) or Energy Commission regulates the safety of electrical equipment by ensuring that electrical equipment sold in the market is safe to use and does not harm consumers. To date, ST regulates 34 categories of electrical equipment. ST certifies electrical equipment’s compliance with Malaysian safety standards before they can be sold to Malaysian consumers.
  • Who Needs It?
    • Importers and manufacturers of electrical goods such as electrical home appliances, lighting fixtures, 3-pin plugs, audio and video equipment, air-conditioners, refrigerators, washing machines, domestic power tools, etc.
  • Our Services:
    • Product compliance testing
    • Document submission
    • Handling interactions with ST authorities
    • Monitoring and managing the process until approval
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NPRA Registration (For Pharmaceuticals, Medical Devices, and Cosmetics)

  • What is NPRA Registration?
    • National Pharmaceutical Regulatory Agency (NPRA) falls under the Ministry of Health Malaysia (MOH). NPRA is the key regulatory body for pharmaceutical products in Malaysia, ensuring that medicines and health supplements meet the required safety and efficacy standards, while being governed by the Ministry of Health.
  • Who Needs It?
    • Businesses importing or manufacturing pharmaceuticals, medical devices, cosmetics, etc. are required to be registered with NPRA. All products under these categories – pharmaceuticals, medical devices, cosmetics, etc. are required to be registered with NPRA before they are sold to Malaysian consumers. NPRA is responsible for evaluating and approving pharmaceutical products (including medicines, health supplements, and cosmetics) before they can be sold in Malaysia. Only products that meet NPRA’s safety, quality, and efficacy standards are granted market authorization.
  • Our Services:
    • Review of product ingredients and formulations
    • Application preparation and submission
    • Ongoing support for any additional documentation requested by NPRA
    • Post-approval compliance monitoring
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