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Medical Products Deal Checklist
Company and/or Manufacturer in China should have experience selling and manufacturing these types of medical products.
RTC requires name of Manufacturer/Supplier that company is importing from to ensure the factory is qualified. Manufacturer/Supplier must be FDA certified.
Freight forwarder and/or Customs Broker must have experience importing these products and is familiar with all FDA regulations that allow importation of these medical products. Included is familiarization with all forms and proper entries to ensure there is no holdup at US customs.
Importer must have applicable customs bond allowing the importation of these types of medical products or will have to obtain a single-entry bond (from customs broker/freight forwarder who Rosenthal will obtain an agreement with as well).
Credit worthy end-buyer/customer backed by verifiable purchase order or contract from such buyer. We will vet with phone verification of the contract or order as needed.
Rosenthal does not send cash in advance to suppliers based in China. If the factory in China is looking for pre-payment or a deposit, factory would need to accept an Irrevocable Documentary Letter of Credit (typically issued through Wells Fargo Bank, N.A.).
Pre-shipment independent 3rd party inspection would be required.
Products may require lab testing as part of inspection procedures.
For N95 masks (U.S. approved specs), products should be stamped with a NIOSH logo and a federal approval number.
For K95 masks (China specs), FDA approved with CE certification.
First priority perfected security interest in the assets financed by R & R subject to any inter-creditor that may be needed if an existing senior financing source is already in place by the proposed borrower for its existing business.
Personal guarantees of the major shareholders of the borrower are generally required.
Air shipment – Air Waybill consigned to (Client/Importer of Record) and indicating Notify/Deliver To: (Ultimate Sales Customer location & contact details).
Additional Information:
The US is now allowed to import FFR masks for medical use that conform to these other countries specs:
Australia – P3, P2; must have marketing authorization ARTG Certificate of Inclusion
Brazil – PFF3, PFF2
Europe – FFP3, FFP2; must have marketing authorization CE mark
Japan – DS/DL3, DS/DL2; must have marketing authorization PMDA or MHLW marks
Korea – Special 1st
Mexico – N100, P100, R100, N99, P99, R99, N95, P95, R95