Initial “Entry to Market” Cost Solutions
At RAF Solutions, we understand that establishing your business in the U.S. and getting the right support and advice can be expensive and risky. That is why we provide a cost-effective solution that allows you to enter the U.S. market with minimal costs and risks. With extensive experience across multi-sectors, we charge an initial set up cost for the administrative work and then a monthly management fee for the required services. As your business expands we work in partnership on the resources and costs needed to achieve this. All at a fraction of the cost of doing it yourself or with other providers.
U.S. Agent / Initial Importer Status Services
The Food and Drug Administration (FDA) require all medical device and IVD companies without an office in the United States to appoint a registered US FDA Initial Importer. The US Importer must maintain a legal office for business in the United States. RAF can serve as an official US Initial Importer for medical device and IVD companies.
Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
As Initial Importer we can facilitate the marketing of devices from a foreign manufacturer to the person who makes the final delivery or sale to your customer. As your designated initial importer, RAF Solutions will
report to FDA any incident where there is a malfunction, serious injury or death. We will maintain an Medical Device Reporting (MDR) event file for each adverse event and forward all product complaints (MDR and non-MDR events) to you and if desired, your contract manufacturer. Additionally, if required, we will track certain devices through the distribution chain.
US Regulatory Affairs (Registration, Compliance, FDA Certification)
– Initial importers/US Agent
• Import/Export Requirements, FDA Certificate to Foreign Government (CFG)
• Official Correspondent and US Agent to the FDA
– Regulatory Assistance
• Assistance in getting your device through regulatory hurdles so you are able to market in the US and abroad.
• FDA clearance (510(k), 513(g) and Pre-IDEs) and FDA approval (PMA and IDEs)
• FDA Establishment Registration and Product Listing
• Medical Device Reporting (MDR) under 21 CFR 803
• Reports of Corrections and Removals under 21 CFR 806
• Medical Device Tracking under 21 CFR 821
U.S. Customs Clearance and Brokerage Services
Warehousing and Distribution into the Americas (U.S., Canada, Mexico, LATAM) and Caribbean
(to include ambient and cool temperature controlled)
• Fully secured Warehouse (temperature controlled) with 24 hours monitored alarm
• Storage – Goods In/Goods Out/Quarantine/ Special Storage Conditions (if required)
• Full managed Warehouse, including shipping direct to customers
• QSR Compliance Documentation and batch traceability
• Stock Management Process, including inventory control/FIFO
• Pest Control Measures in Place
– Order Fulfillment
– Shipping and Tracking
• Transportation management with commercial carriers (FedEx, DHL, UPS, common carrier)
• Same day shipping for orders received by noon (EST)
• Tracking reporting available
– Inventory Management
– Customer Invoicing and First Point of Contact Services
• Receiving of Customer phone calls (dedicated line if required)
• Customer queries including requests for Literature, clinical papers etc
• Correspondence (email / letters)
• Customer Purchase orders processed and dispatched
• All relevant documentation sent to customer (on Client Headed Paper) i.e. Delivery Notes (with shipment)
• Reporting to Client, Weekly Inventory and Sales, Monthly Inventory and any other reports deemed necessary
• Customer Complaint handling and documentation
• Support sales team with provisions of stock / literature etc.
• Office Hours from 9am to 4.30pm Monday to Friday and USA – Bank Holidays are honored*-
– Product Recall Services