1 Qualifications & Compliance (The Non-Negotiables)
Medical Device Manufacturing License (verifying scope, address, and validity).
Valid NMPA product registration certificates.
Overseas access: IVDR CE (EU 2017/746) with Notified Body certificates, TFDA, SFDA, ANVISA, etc.
ISO 13485 QMS certification and audit-readiness for overseas authorities.
2 Product Portfolio & Performance
Complete test menu: Analyzers, reagents, calibrators, and controls.
Clear competitive advantage vs. top global brands
3 Manufacturing & Supply Chain Resilience
Actual production capacity and raw material sourcing (in-house vs. outsourced antigens/antibodies)
Packaging & multi-language labeling compliant with local regulations.
4 Technical & After-Sales Support
Able to deliver good service to the distributor