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Authorized representative of medical products in the USA.

We act as Authorized Representatives of medical devices in the US. We prepare the documentation for your subsequent registration and advise you on the process so that you comply with the strict FDA regulations.

US FDA Medical Device Registration Procedure

In the US, medical devices are regulated by the Center for Devices and Radiological Health (CDRH), under the Food and Drug Administration (FDA), through Title 21 of the Code of Federal Regulations (21 CFR), Parts 800 - 1299, and the labeling requirements of 21 CFR Part 801.

Steps to register

1. Device classification

2. Identification of QSR requirements

3. Device identification

4. Creation and validation of electronic copies

5. Preparation of the technical file

6. Analysis of source documents

7. Submission of the application

8. FDA approval

9. Appointment of an agent in the USA

10. Registration of establishments and list of devices

11. Approval of Activities after approval

USA

US FDA Agent

Companies that do not have physical headquarters in the United States must designate a representative known as a US FDA agent. This agent must be based in the US or have a commercial presence in this country. The specific duties and obligations of this agent are established by the US FDA as set forth in the Code of Federal Regulations (CFR).

Classification and registration of medical devices in the USA.

Devices can be approved by the CDRH, FDA through any of the various registration pathways. They are listed as:

They are listed as:

  • Class I medical devices: These are devices that are generally considered low risk. For these products, manufacturers typically do not have to go through the 510(k) filing process or comply with good manufacturing practices (GMP) standards. However, they must meet requirements such as registering their establishment, listing their device, applying the unique device identification (UDI) system, and maintaining a post-market surveillance (PMS) system.

  • Class II medical devices: Products in this category present a moderate level of risk. If a similar device (known as a predicate device) has been previously approved through the 510(k) process, manufacturers can apply for approval of their device by demonstrating its substantial equivalence (SE) to the predicate device. The 510(k) route, often called Premarket Notification (PMN), is a commonly used method for these devices. Manufacturers who do not have a suitable reference product may request the FDA to evaluate the classification of their product through the De-Novo application.

  • Class III medical devices: These are the highest risk devices. Manufacturers wishing to bring them to market must submit a complete application for premarket approval (PMA) to the FDA. This process involves rigorous evaluation, including a comprehensive clinical evaluation. Manufacturers must submit comprehensive data on the safety and effectiveness of their device, often from clinical trials. Additionally, the FDA may conduct a quality management system (QMS) inspection as part of the evaluation process before granting the PMA for the device.

If you need more information, do not hesitate to contact us

Responsibilities of medical device manufacturers after approval

The responsibilities that manufacturers have after approval are the following:

  • Registration and listing: Manufacturers of all device categories must register their establishments in the FURLs database. Additionally, once authorization is granted, the specific device must be listed before it can be introduced into the US market. In particular, devices such as those that emit radiation have additional prerequisites, including obtaining an access number, before they can be introduced into the US.

  • Unique Device Identification (UDI): Regardless of product class, all medical devices destined for the US market must comply with UDI standards.

  • Establishment Fees: To maintain active registration of their establishment and continue to market their devices in the US, manufacturers must pay annual establishment fees. However, it is worth noting that the FDA offers a discounted fee structure for smaller businesses that hold an active Small Business Certificate.

  • Quality Audits: For devices that are not exempt from Good Manufacturing Practices (GMP), the FDA reserves the right to conduct unannounced inspections at manufacturing facilities. The purpose of these inspections is to ensure that manufacturers are complying with Quality Systems Regulation (QSR), as set forth in 21 CFR 820.

If you need more information, do not hesitate to contact us

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