Aztech Global’s Johor plant gains FDA 21 CFR 807 registration, opening door to US medical device manufacturing
Summary:
-
Aztech Global’s wholly owned Malaysia facility, IOT Manufacturing Sdn. Bhd. in Pasir Gudang, has secured FDA Establishment Registration and Device Listing under 21 CFR Part 807, on top of existing ISO 13485 certification.
-
The 300,000 sq ft Johor plant, which already manufactures and packages IoT products for global customers, is now positioned as a scalable, compliant contract manufacturer for medical device owners targeting the US market.
-
The registration allows US-focused device owners to shorten time-to-market by leveraging a pre-registered manufacturing partner, with quality anchored in an ISO 13485–certified QMS and Aztech’s vertically integrated, Singapore-listed platform.
-
Aztech highlights supportive macro tailwinds: the US remains over 40% of global MedTech demand (US$188.7 billion market in 2024), while Malaysia exports over 90% of its medical devices, with about 37% going to the US.
-
Management frames the milestone as part of a broader strategy to build a one-stop MedTech manufacturing ecosystem spanning FDA-aligned QMS, controlled environments, precision engineering, DFM, and comprehensive testing to support global market expansion.