Local registration
Product availability, claims, labeling and intended use must follow each country’s medical device and IVD rules.
Singapore · China · Brazil · Americas
A global operating model for rapid diagnostics.
AmazonGene is positioned as an international IVD company, combining Singapore headquarters, China manufacturing operations, and regional offices serving Brazil and the Americas.
International structure
Global brand, regional execution.
The website communicates international credibility while allowing each market to follow its own regulatory, labeling and distribution requirements.
✓
Singapore headquartersGlobal strategy, commercial governance and international contracting.
✓
China manufacturingManufacturing base, supply-chain coordination and product documentation.
✓
Brazil officeANVISA pathway support, local distribution and public/private market development.
✓
Americas expansionDistributor development, institutional sales and regional product strategy.
Market principle
One global brand. Country-specific availability.
Diagnostic products cannot be marketed the same way in every country. AmazonGene’s website is designed to separate global positioning from local regulatory status.
Distributor channels
Market access is built through qualified distributors, institutional buyers and local regulatory execution.
Documentation discipline
Each product category should maintain clear technical files, instructions for use, labels and performance summaries.
Represent AmazonGene in your market.
Qualified distributors can request a private portfolio review and discuss country-specific product availability.