- Establishment must be registered with the FDA
- Establishment must have a physical address in the United States, as well as a staffed by responsible individuals to ensure the compliance of all FDA laws and regulations.
- Responsible for registering, reporting, and archiving all non-conformities, customer complaints, recalls and all post-market survey activities.
- Responsible for Medical Device Tracking of certain devices through the supply chain.
Don't make the mistake to confuse US Agent or distributor with the Initial Importer role.
- Assisting FDA in communications with the foreign establishment.
- Responding to questions concerning the foreign establishments devices that are imported or offered for import into the United States.
- Assisting FDA in scheduling inspections of the foreign establishment.
- If the FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
PLEASE NOTE THAT THE U.S. AGENT HAS NO RESPONSIBILITY RELATED TO REPORTING OF ADVERSE EVENTS UNDER THE MEDICAL DEVICE REPORTING REGULATION (21 CFR PART 803) OR SUBMITTING 510(K) PREMARKET NOTIFICATIONS (21 CFR PART 807, SUBPART E).
Distribution networks are crucial for a profitable medical device company, therefore, we have tailored our services to help you find the best distributors for your needs by:
- Finding qualified distributors for your device’s field, or expertise.
- Maintaining a strong, mutually beneficial relationship.
- Negotiating contracts.
- Constantly looking for new, qualified distributors.
- Provide training and continuous follow ups with distributors.
- Act as as key contact for the distributor in the United States.
Certificate to Foreign Government (CFG)
Certificates to Foreign Governments (CFG) are crucial to expanding your business into foreign markets. In fact, many Asian, Middle Eastern, & Latin American countries require a CFG in order to sell medical devices within their borders. As a US domestic company registered with the FDA, Dawa Medical will conduct the entire procurement process for you.
- The establishment must be registered with the FDA;
- The device must be listed with the FDA;
- The device must have a cleared Premarket Notification [(510(k)] , an approved Premarket Approval (PMA) Application (unless exempted by regulation), is a device that was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act), or was granted a De Novo classification;
- The device must meet the labeling requirements of Title 21 Code of Federal Regulations (CFR) Part 801 (21 CFR 801) or 21 CFR 809, if applicable;
- The device must be manufactured in accordance with the Quality System (QS) regulation of 21 CFR 820, unless exempted by regulation.