{"id":16933,"date":"2026-01-23T09:40:11","date_gmt":"2026-01-23T02:40:11","guid":{"rendered":"https:\/\/manufacturing-review.com\/?p=16933"},"modified":"2026-01-23T09:40:11","modified_gmt":"2026-01-23T02:40:11","slug":"aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market","status":"publish","type":"post","link":"https:\/\/manufacturing-review.com\/en\/aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market\/","title":{"rendered":"AZTECH GLOBAL SECURES\u00a0FDA REGISTRATION FOR ITS MALAYSIA FACILITY, STRENGTHENING ITS POSITION AS A MANUFACTURING PARTNER FOR MEDICAL DEVICE OWNERS FOR THE US MARKET"},"content":{"rendered":"

SGX Mainboard-listed Aztech Global Ltd. (\u201cAztech\u201d) is proud to announce that its wholly-owned Malaysia manufacturing facility,\u00a0IOT Manufacturing Sdn. Bhd. (\u201cIOTM\u201d)<\/b>\u00a0has received its\u00a0Certificate of Registration<\/b>\u00a0under the\u00a0U.S. Food and Drug Administration\u2019s (\u201cFDA\u201d)<\/b>\u00a021 CFR Part 807[1]<\/span><\/a>\u00a0Establishment Registration and Device Listing (\u201c21CFR807\u201d). Located in Pasir Gudang, Johor, Malaysia,\u00a0IOTM is also ISO 13485 certified<\/b>, reinforcing Aztech\u2019s readiness to serve as a scalable, compliant and preferred manufacturing partner for medical device owners seeking accelerated entry to the United States (\u201c<\/span>U.S.\u201d) market.<\/p>\n

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\u201cMedical device owners increasingly need manufacturing partners who can deliver speed without compromising compliance,\u201d said\u00a0Mr. Michael Mun, Executive Chairman and CEO of Aztech Global Ltd.<\/b>\u00a0\u201cWith FDA establishment registration under 21 CFR Part 807 and our established track record in manufacturing IoT products for the U.S. market, Aztech is well-positioned to help customers accelerate their journey \u2014 from industrialisation and production through to commercial supply and end-market delivery.<\/p>\n

 <\/p>\n

Aztech as Preferred Medical Device Manufacturer for Rapid Entry into the U.S. Market<\/span><\/b><\/p>\n

IOTM is a 300,000 square feet manufacturing facility situated on approximately 9.11 acres of land. 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 the expertise of Aztech\u2019s three R&D centres, the facility delivers seamless solutions from product design through commercial-scale manufacturing.<\/p>\n

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With its ISO 13485 certification and 21CFR807, IOTM is purpose-built and ready to support medical device owners seeking to:<\/p>\n

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\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Reduce\u00a0<\/b>time-to-market\u00a0<\/span><\/b>by engaging a manufacturing partner already registered under\u00a0<\/span>21CFR807, a mandatory requirement for manufacturing, importing, and marketing medical devices in the U.S.<\/span><\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Assurance of device quality<\/b>\u00a0through production under an ISO 13485\u2013certified quality management system<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Scale production reliably and globally<\/b>\u00a0through a mature manufacturing footprint backed by a Singapore-listed company with an established vertically integrated global network<\/p>\n

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Diversify supply chains<\/b>\u00a0and leveraging Malaysia\u2019s position as a highly export-oriented medical device manufacturing hub \u2014 with over 90% of locally manufactured medical devices exported and\u00a0more than half going to major markets including the U.S.<\/b>, underlining the country\u2019s strategic role in global MedTech supply chains[2]<\/span><\/a>.<\/p>\n

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Leveraging the U.S.\u2013Malaysia Trade Synergy for the World\u2019s Largest MedTech Market<\/span><\/b><\/p>\n

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Demand trends\u00a0<\/b>– The U.S. remains the world\u2019s largest medical device market, representing over 40% of global MedTech demand. In 2024, the U.S. medical device market was valued at approximately SGD242.3 billion (US$188.7 billion)[3]<\/span><\/a>, underscoring the continued need for compliant and scalable manufacturing partners to support market expansion[4]<\/span><\/a>.<\/p>\n

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Supply trends<\/b>\u00a0–\u00a0<\/b>Malaysia continues to strengthen its role in global MedTech supply. In 2024, Malaysia\u2019s medical device exports to the U.S. accounted for nearly 37% of its total global medical device exports[5]<\/span><\/a>. Malaysia remains a strategic base for global MedTech and this momentum is underpinned\u00a0by its advanced industrial infrastructure and international port connectivity\u00a0<\/span>that support efficient global supply.<\/p>\n

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Aztech\u2019s One-Stop Manufacturing Platform for Your Global MedTech Expansion<\/span><\/b><\/p>\n

With continued investments in advanced manufacturing technologies and regulatory-compliant processes, strategically located manufacturing facilities, and a proven track record of delivering high-quality IoT products for global markets, Aztech is well positioned to support medical device owners across the full U.S. market lifecycle.<\/p>\n

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Aztech\u2019s\u00a0integrated medical device manufacturing ecosystem<\/b>\u00a0includes:<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0 FDA aligned quality management systems<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0 Controlled environment production<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0 Precision engineering and automated assembly<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0 Design for manufacturing (\u201cDFM\u201d) and prototyping support<\/p>\n

\u2022\u00a0\u00a0\u00a0\u00a0\u00a0 Comprehensive testing and validation capabilities<\/p>\n

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This milestone reinforces Aztech\u2019s long-term strategy to expand its global MedTech manufacturing footprint and serve as a scalable, compliant and trusted partner for medical device owners seeking accelerated entry and growth in the U.S. market.<\/p>\n

\u00a0<\/i><\/b><\/p>\n

Regulatory Note:<\/i><\/b><\/p>\n

FDA Establishment Registration and Device Listing under 21 CFR Part 807 provides the FDA with information about medical device establishments and their activities. It is distinct from, and does not itself constitute, FDA marketing authorisation or clearance\/approval for any specific device.<\/i><\/p>\n

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\u00a0<\/span><\/b><\/p>\n

About Aztech Global Ltd.\u00a0<\/span><\/b>www.aztechglobal.com<\/a><\/span><\/b><\/p>\n

Aztech Global Ltd. (stock code: 8AZ) together with its group of companies (\u201cAztech\u201d) is a designer and manufacturer of IoT devices and data-communication products across diverse market segments including security, consumer, communications, health-tech, industrial and automotive. Supported by its comprehensive suite of design, engineering, and manufacturing services, Aztech prides itself as the key technology enabler across its clientele base that ranges from blue chip customers to technological start-ups with innovative products.<\/p>\n

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Headquartered in Singapore, Aztech traces its roots to a group founded in 1986. It operates three R&D centres in Singapore, Hong Kong and Shenzhen, China and two manufacturing facilities in Dongguan, China and Johor, Malaysia, supported by a workforce of about 2,000. Its manufacturing facilities are ISO 9001-, 13485-, 14001-, 45001- and IATF 16949-certified demonstrating Aztech\u2019s commitment to quality and compliant products, workplace safety and environmental responsibility. The Malaysia facility is also U.S. FDA-registered under 21 CFR 807, strengthening Aztech\u2019s ability to manufacture medical devices that require stringent regulatory compliance.<\/p>\n

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Recognising that a thriving community and resilient climate contributes to long-term business resilience, Aztech supports initiatives that promote inclusion, entrepreneurship, and climate resiliency. Its commitment to business excellence, ESG and governance has also been endorsed with awards and accolades. The list includes The Enterprise Award at the Singapore Business Awards 2025, The Edge Singapore Centurion Club 2024 Award – Highest Growth in Profit After Taxes over Three (3) Years\u201d for the Software & IT Services and Technology Equipment sector, Investors\u2019 Choice Awards 2024 Singapore Corporate Sustainability Award (Mid Cap Category) and Most Transparent Company Award (Technology Category) by SIAS, Singapore\u2019s Best Managed Companies 2024 and 2025 by Deloitte, 200 Best Under a Billion 2024 and Special Award \u2013 Best Return on Equity by Forbes Asia, Fortune SEA 500 company in 2024 and 2025, Singapore\u2019s Fastest Growing Companies from 2023 to 2025 by the Straits Times, and Asia Pacific\u2019s High-Growth Companies 2024 by the Financial Times.<\/p>\n

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\u00a0<\/span><\/p>\n

For more information, please contact:<\/span><\/b><\/p>\n

Ms. Clarie Lim (Investor Relations Manager)\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Ms. Yvonne Yeo (Senior Manager, Marcom)<\/span><\/p>\n

Tel: +65 6594 2280 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Tel: +65 6594 2175<\/span><\/p>\n

E-mail:\u00a0<\/span>Clarie.Lim@aztech.com<\/a><\/span>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Email:\u00a0<\/span>Yvonne.Yeo@aztech.com<\/a><\/span><\/p>\n<\/div>\n


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[1]<\/span><\/span><\/a>\u00a0According to FDA.Gov (30 Sep 2025), owners or operators of establishments involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA under the Code of Federal Regulations (CFR). This requirement is set out in 21 CFR Part 807, which governs FDA establishment registration and device listing.<\/span><\/p>\n

\u00a0<\/span><\/p>\n<\/div>\n

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[2]<\/span><\/span><\/a>\u00a0Source: ASEAN Briefing, Malaysia\u2019s Healthcare Sector: A Rising Giant in ASEAN (2024).<\/span><\/p>\n<\/div>\n

\n

[3]<\/span><\/span><\/a>\u00a0Currency conversion rate is based on an estimated rate of US$1:SGD1.2841<\/span><\/p>\n<\/div>\n

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[4]<\/span><\/span><\/a>\u00a0Source: U.S. Medical Devices Market Size, Share & Forecasts 2024\u20132032, Fortune Business Insights<\/span><\/p>\n<\/div>\n

\n

[5]<\/span><\/span><\/a>\u00a0Source: The Star \/ Asianews report on Malaysia\u2019s medical device exports to the U.S. in 2024.<\/span><\/p>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

SGX Mainboard-listed Aztech Global Ltd. (\u201cAztech\u201d) is proud to announce that its wholly-owned Malaysia manufacturing facility,\u00a0IOT Manufacturing Sdn. Bhd. (\u201cIOTM\u201d)\u00a0has received its\u00a0Certificate of Registration\u00a0under the\u00a0U.S. Food and Drug Administration\u2019s (\u201cFDA\u201d)\u00a021 CFR Part 807[1]\u00a0Establishment Registration and Device Listing (\u201c21CFR807\u201d). 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(\u201cAztech\u201d) is proud to announce that its wholly-owned Malaysia manufacturing facility,\u00a0IOT Manufacturing Sdn. Bhd. (\u201cIOTM\u201d)\u00a0has received its\u00a0Certificate of Registration\u00a0under the\u00a0U.S. Food and Drug Administration\u2019s (\u201cFDA\u201d)\u00a021 CFR Part 807[1]\u00a0Establishment Registration and Device Listing (\u201c21CFR807\u201d). Located in Pasir Gudang, Johor, Malaysia,\u00a0IOTM is...","og_url":"https:\/\/manufacturing-review.com\/aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market\/","og_site_name":"Manufacturing Review","article_published_time":"2026-01-23T02:40:11+00:00","og_image":[{"width":551,"height":310,"url":"https:\/\/manufacturing-review.com\/wp-content\/uploads\/2026\/01\/11222.jpg","type":"image\/jpeg"}],"author":"admin","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/manufacturing-review.com\/aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market\/","url":"https:\/\/manufacturing-review.com\/aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market\/","name":"AZTECH GLOBAL SECURES\u00a0FDA REGISTRATION FOR ITS MALAYSIA FACILITY, STRENGTHENING ITS POSITION AS A MANUFACTURING PARTNER FOR MEDICAL DEVICE OWNERS FOR THE US MARKET - Manufacturing Review","isPartOf":{"@id":"https:\/\/manufacturing-review.com\/#website"},"datePublished":"2026-01-23T02:40:11+00:00","dateModified":"2026-01-23T02:40:11+00:00","author":{"@id":"https:\/\/manufacturing-review.com\/#\/schema\/person\/51946b4afd6c6dae9baea1bd2150c646"},"breadcrumb":{"@id":"https:\/\/manufacturing-review.com\/aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/manufacturing-review.com\/aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/manufacturing-review.com\/aztech-global-secures-fda-registration-for-its-malaysia-facility-strengthening-its-position-as-a-manufacturing-partner-for-medical-device-owners-for-the-us-market\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/manufacturing-review.com\/"},{"@type":"ListItem","position":2,"name":"AZTECH GLOBAL SECURES\u00a0FDA REGISTRATION FOR ITS MALAYSIA FACILITY, STRENGTHENING ITS POSITION AS A MANUFACTURING PARTNER FOR MEDICAL DEVICE OWNERS FOR THE US MARKET"}]},{"@type":"WebSite","@id":"https:\/\/manufacturing-review.com\/#website","url":"https:\/\/manufacturing-review.com\/","name":"Manufacturing Review","description":"Manufacturing Review","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/manufacturing-review.com\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/manufacturing-review.com\/#\/schema\/person\/51946b4afd6c6dae9baea1bd2150c646","name":"admin","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/manufacturing-review.com\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/bcb2299908f941d18c8c8311babe313c?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/bcb2299908f941d18c8c8311babe313c?s=96&d=mm&r=g","caption":"admin"},"url":"https:\/\/manufacturing-review.com\/en\/author\/admin\/"}]}},"_links":{"self":[{"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/posts\/16933"}],"collection":[{"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/comments?post=16933"}],"version-history":[{"count":2,"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/posts\/16933\/revisions"}],"predecessor-version":[{"id":16936,"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/posts\/16933\/revisions\/16936"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/media\/16934"}],"wp:attachment":[{"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/media?parent=16933"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/categories?post=16933"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/manufacturing-review.com\/en\/wp-json\/wp\/v2\/tags?post=16933"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}