Medical Device Listing and Establishment Registration

Medical Device Listing and Establishment Registration

We help medical device manufacturers ensure that they meet the FDA requirements in listing and registration of a device, and thus properly list their devices and have their establishments registered to get into the market.

Medical Device Listing and Establishment Registration are two foundational steps in the FDA regulatory process for medical devices. Compliance with these requirements is essential to the marketing and distribution of devices legally in the United States. At ADBC CRO, we offer you expert help to ensure your devices are properly listed with the FDA and your manufacturing establishment is appropriately registered, streamlining your path to market approval.

Why Choose ADBC CRO for Medical Device Listing and Establishment Registration?

  • Regulatory Expertise:
    Our team is well-versed in FDA regulations for medical device registration and listing, ensuring that your submissions meet all required standards.
  • Streamlined Process
    We help to make the FDA registration process more straightforward for you. We assist you in performing the right actions and help ensure that your devices and establishment are registered and listed appropriately.
  • Ongoing Support
    We support you from initial registration to yearly updates in keeping up with changes in the regulatory requirements.

Our Medical Device Listing and Establishment Registration Services Include

Establishment Registration We can help you register your manufacturing establishment with the FDA, which is a mandatory requirement for those who engage in the manufacturing, preparation, and distribution of medical devices within the United States.
Device Listing We assist you in listing your devices with the FDA, with each device being correctly categorized and compliant with the classification requirements of the FDA.
Product Classification Help We can assist in the proper classification of your medical devices so that every product gets the right FDA product code according to its use and regulatory requirements.
Annual Updates and Amendments We provide on-going support to ensure that the establishment registration and device listing for your company are updated each year, as required by the FDA, and amended whenever the information for devices changes, like manufacturing or labeling.
Regulatory Compliance Consulting We make sure that the device listing and establishment registration for your company are all in compliance with all applicable FDA regulations and guidelines, and thus not subject to compliance issues.
Global Registration Support We also support the registration needs of medical devices in international markets, so your device will be compliant with global regulatory requirements.

Contact us for medical device listing and FDA registration services!

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Global Impact

Our mission extends beyond delivering products and services; we are dedicated to making a lasting positive impact across the globe. Through our commitment to excellence in customer service, product innovation, and regulatory compliance, we drive sustainable growth, foster trust, and set new standards within our industry. Each initiative is part of our vision to empower communities, support industries, and contribute meaningfully to a better world.

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