Aztech Global Ltd. (8AZ) said on Jan, 22 2026 that its wholly owned manufacturing plant in Pasir Gudang, Johor, IOT Manufacturing Sdn. Bhd., has been registered with the U.S. Food and Drug Administration under 21 CFR Part 807.

The 300,000-square-foot facility, which sits on about 9.11 acres of land, is also ISO 13485 certified, enabling it to produce medical devices under an FDA-aligned quality management system.

With the registration in place, Aztech Global can manufacture, import and market medical devices for customers seeking faster access to the United States, the world’s largest medical device market, valued at roughly 242.3 billion Singapore dollars in 2024.

Malaysia remains a key supply base for the sector, with nearly 37% of its 2024 medical device exports destined for the United States, according to publicly available trade data.

Aztech Global said the new certification complements its existing IoT manufacturing capabilities and supports its strategy to grow as a compliant, scalable partner for medical device owners targeting the U.S. market.