Ensure FDA  
Compliance With
Accurate Product
Listings

To legally market medical devices in the United States, companies must register their establishments with FDA  and list their devices.

Failure to list medical devices correctly may result in registration delays, import detentions, and enforcement actions, preventing products from reaching the market.

Registrar Corp helps manufacturers, distributors, and exporters properly list their medical devices with FDA to avoid compliance issues.

List your Medical Device

Medical devices -Services product listings hero image

2,000+ Medical Device Manufacturers Trust Registrar Corp

What Is a Medical Device Listing?

A medical device product listing is a mandatory submission to FDA that
provides details about a device, including:

Device and brand name

Classification and product code

Regulatory pathway (510(k), PMA, etc.)

Intended use

Manufacturer/developer info

Packaging, sterilization, accessories

Each device must be listed individually, with updates required for new products or major changes.

Who Needs to List Their Medical Devices With FDA?

Manufacturers

Companies that produce finished medical devices.

Contract Manufacturers

Companies that manufacture devices on behalf of another company.

Specification Developers

Companies that design and develop devices but do not manufacture them.

Repackers & Relabelers

Companies that repackage or relabel devices for distribution.

Initial Distributors (Importers)

Foreign manufacturers must ensure that their U.S. distributors are properly listed.

Steps to List a Medical Device With FDA

Classify the Device

Determine Class I, II, or III to identify regulatory
requirements (exempt, 510(k), or PMA).

Select the Right Product Code

Matches device’s use and technology; errors can cause
compliance issues.

Register the Establishment

Manufacturers/distributors must register with FDA and
renew  annually (Oct 1–Dec 31).

Submit Device Listing

Enter accurate details into FDA’s Device Registration and Listing
Module (DRLM) system.

Maintain & Update Annually

Revise listings for any changes and renew each year to stay active.

Common Issues With Medical Device Listings

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Incorrect Classification or Product Code

Submitting the wrong classification or product code can
lead to delays or enforcement actions.

Missing or Incomplete Information

Failure to provide all required details can cause listing rejections.

Outdated Listings

Listings that are not updated with new product information may become invalid.

Failure to List All Distributed Devices

Every device must be listed separately, and missing product listings can result in non-compliance.

How Registrar Corp Helps With Medical Device Listings

Product Classification

Identify correct class,
product code, and
regulatory pathway (510(k),
PMA, or exempt).

Ongoing Compliance

Monitor, update, and
renew listings to meet
FDA requirements.

FDA Submission

We prepare and submit
accurate listings
on your behalf.

U.S. Agent & Registration

Provide 24/7 U.S. Agent
services and handle full
establishment registration.