Key Highlights for Investors

• FDA Registration Secured: Aztech Global Ltd., via its wholly-owned Malaysian subsidiary IOT Manufacturing Sdn. Bhd. (IOTM), has obtained the Certificate of Registration under the U.S. Food and Drug Administration’s 21 CFR Part 807. This registration is an essential prerequisite for manufacturing, importing, and marketing medical devices in the United States.
• ISO 13485 Certified Facility: The Malaysia facility is also ISO 13485 certified, ensuring a robust quality management system for medical device production. This dual certification positions Aztech as a highly credible and compliant manufacturing partner for global medical device owners.
• Strategic Manufacturing Footprint: IOTM spans 300,000 square feet on 9.11 acres in Pasir Gudang, Johor, Malaysia. Since 2023, it has supported the manufacturing and vertically integrated packaging needs of global IoT product owners, leveraging state-of-the-art production capabilities and expertise from Aztech’s three R&D centres.
• Proven Track Record: Aztech’s established experience in manufacturing IoT products for the U.S. market further strengthens its value proposition as a partner for rapid industrialisation, production, and commercial supply of medical devices.
• Regulatory and Quality Advantages:
  • Accelerated time-to-market for medical device owners, leveraging Aztech’s pre-existing FDA registration.
  • High assurance of device quality through ISO 13485–certified manufacturing processes.
  • Ability to scale production globally, backed by a Singapore-listed company with a vertically integrated network.
  • Strategic location in Malaysia, which exports over 90% of locally manufactured medical devices, with more than half going to major markets including the U.S.
• Market Opportunity: The U.S. remains the world’s largest medical device market, representing over 40% of global MedTech demand and valued at SGD242.3 billion (US\$188.7 billion) in 2024. Malaysia is a key exporter, with nearly 37% of its total medical device exports going to the U.S.
• Integrated Manufacturing Ecosystem: Aztech offers FDA-aligned quality management systems, controlled environment production, precision engineering, automated assembly, DFM and prototyping support, and comprehensive testing and validation capabilities.
• ESG and Corporate Governance Excellence: Aztech has received numerous awards for business excellence, ESG, and transparency, including the Singapore Business Awards, Deloitte’s Best Managed Companies, Investors’ Choice Awards, and recognition from Forbes Asia, Fortune, Straits Times, and Financial Times.

Potential Share Price Impact

The FDA registration for Aztech’s Malaysia facility is a significant and potentially price-sensitive development. It positions Aztech to capture new U.S. market share in the lucrative medical device segment, accelerates regulatory compliance for customers, and enhances its reputation as a trusted manufacturing partner. This milestone could lead to increased orders, expanded customer base, and higher revenue streams, particularly from U.S.-based medical device owners seeking rapid and compliant market entry.

Furthermore, given the competitive advantages of Aztech’s vertically integrated global network, advanced R&D, and ESG credentials, the company is poised for further growth and value creation for shareholders. The strategic location in Malaysia—a global MedTech manufacturing hub with efficient port connectivity—could also drive long-term operational efficiencies and supply chain diversification, both of which are critical in today’s geopolitical and regulatory environment.

Important Notes for Shareholders

• FDA Registration is Not Device Approval: FDA Establishment Registration and Device Listing under 21 CFR Part 807 provides the FDA with information about the establishment and its activities. It does not constitute FDA marketing authorisation or clearance/approval for any specific device.
• Growth Potential: Aztech’s facility is ready to support new and existing medical device owners seeking to scale up production for the U.S. market, presenting significant growth opportunities.
• Operational Resilience: The facility’s certifications (ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949) and strategic location enhance Aztech’s operational resilience and ability to meet varied customer requirements.
• Awards and Recognition: Multiple industry awards reinforce Aztech’s commitment to excellence, transparency, and sustainable growth.

Contact Information

Investor Relations:
Ms. Clarie Lim, Investor Relations Manager
Tel: +65 6594 2280
Email: [email protected]

Media Enquiries:
Ms. Yvonne Yeo, Senior Manager, Marcom
Tel: +65 6594 2175
Email: [email protected]

Disclaimer: The above article is for informational purposes only and does not constitute investment advice or an offer to buy or sell securities. Share price movements are subject to market forces and investor sentiment. Investors should conduct their own due diligence and consult with professional advisors before making investment decisions.

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