Regulatory Service

Medical Device Registration in Malaysia, Singapore, Indonesia, Philippines, Thailand and Vietnam

With a dedicated team skilled in navigating the complex regulatory landscapes of Southeast Asia, MEDIVEN specialize in seamless product registration across diverse markets in the region. Our expertise spans a wide array of medical and diagnostic devices, with a strong track record of successful registrations from Class A to Class D products. At MEDIVEN, we prioritize efficient and reliable registration processes, backed by our EN ISO 13485-certified entities across Southeast Asia.

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Comprehensive Registration Services:

  • Medical Devices (Class A to D): From general medical devices like gloves and surgical staples to advanced equipment such as ultrasound systems, we ensure full compliance with regional regulatory standards.
  • In Vitro Diagnostic Kits (Class A to D): Over 100 IVDs successfully registered, including rapid test kits and molecular assays for infectious diseases such as COVID-19, HIV, Drugs of Abuse, Dengue, Influenza, Syphilis, HBV, and HCV.

With deep expertise and proven success in regulatory registration, our team is ready to guide you through every step of the process, ensuring timely approvals and market access across Southeast Asia.