How do I import surgical forceps tissue hemostatic from Pakistan to USA?
Expert Answer
To import surgical forceps tissue hemostatic from Sialkot, Pakistan to USA: 1) Critical: Only FDA Green List manufacturers can export to USA without detention under Import Alert 76-01, 2) Verify manufacturer's Green List status on FDA CDRH website, 3) Required: ISO 13485 (medical device quality), CE marking (for EU), FDA facility registration and device listing, 4) Third-party QSR audit must be submitted to CDRH at cdrhpakistaniaudit@fda.hhs.gov, 5) Instruments must be stainless steel (typically 410, 420, or 304 grade), 6) HS Code: 9018.90, 7) USA duty: 0-2.7%. Production: 3-6 weeks. Shipping: 20-25 days by sea. Sourxera works exclusively with FDA Green List Sialkot manufacturers for USA-bound surgical instruments.
Key Insight
To import surgical forceps tissue hemostatic from Sialkot, Pakistan to USA: 1) Critical: Only FDA Green List manufacturers can export to USA without detention under Import Alert 76-01, 2) Verify manufacturer's Green List status on FDA CDRH website, 3) Required: ISO 13485 (medical device quality), CE marking (for EU), FDA facility registration and device listing, 4) Third-party QSR audit must be submitted to CDRH at cdrhpakistaniaudit@fda.
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