US Regulatory Affairs (Registration, Compliance, FDA Certification)
Requirements for U.S. Agent
Foreign establishments who import or offer for import into the United States must identify an FDA U.S. Agent during the registration process. The FDA U.S. Agent must be physically located in the United States and will serve as the primary and/or default point of contact between FDA and the firm.
RAF Solutions USA is registered with the FDA and Customs to represent you as your U.S. Agent.
The responsibilities of the FDA U.S. Agent are defined in 21 CFR 207.69 as:
- Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications
- Responding to questions concerning those drugs that are imported or offered for import to the United States.
- Assisting FDA in scheduling inspections
- If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA’s providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.
Requirements for Initial Importer
The FDA requires all foreign medical device manufacturers to appoint a registered FDA Initial Importer during device registration. Most distributors and sales reps do not want to get involved or register with the FDA. As a registered agent with the FDA, we take that responsibility as your Initial Importer and are the first point of contact for the FDA for your company. As your Initial Importer, we will make compliance simple, and we are the liaison between you and the FDA.
The responsibilities of Initial Importer are defined as:
- The Initial Importer must have offices in the U.S.
- The FDA sees the Initial Importer as the representative of the manufacturer in the USA
- Satisfy Medical Device Reporting requirements (21 CFR 803.40 and 21 CFR 803.42): report all incidents and adverse events resulting in death or serious injury to the patient, as well as any malfunctions of the devices he imports, to the FDA
- Register, report and archive all non-conformities, customer complaints, recalls and all post-market survey activities
- Conform with specific procedures envisaged in 21 CFR 820 regarding the storage, keeping and handling of the devices he imports
- ensure the tracking of the devices he imports (21 CFR 821)
- Required to register their premises with the FDA and is subject to inspection by the FDA itself.
While it may be confusing, it is essential that you understand the difference of the US Agent, who has a purely administrative role, with that of the Initial Importer who, has specific regulatory responsibilities in the distribution of your devices and products. RAF Solutions USA provide both services to help protect your business by ensuring full compliance with all governmental regulations.