MEDICAL DEVICE FACILITY REGISTRATION AND DEVICE LISTING

The FDA Medical Device Facility Registration and Device Listing are mandatory for companies involved in manufacturing, processing, packaging, or distributing medical devices in the U.S. market. Non-compliance can result in product detentions, customs delays, and loss of market access. IFC Global, as an FDA-recognized U.S. Agent, provides expert support to streamline your registration process, ensuring full compliance and uninterrupted business operations.

Medical Device Facility Registration

The FDA requires all medical device manufacturers, processors, packagers, and distributors to register their facilities. This registration confirms compliance with U.S. regulations and ensures that only approved medical devices enter the market.

Who Must Register?

• Medical device manufacturers producing devices for the U.S. market.
• Packagers and relabelers handling medical devices.
• Distributors of FDA-regulated medical devices.

Why is Registration Essential?

• Customs Compliance – Prevent product detentions and avoid costly entry delays.
• Regulatory Alignment – Ensure your facility meets FDA safety and quality requirements.
• Market Access – Gain legal approval to sell medical devices in the U.S.

Medical Device Listing

In addition to facility registration, the FDA requires each medical device to be listed before it can be marketed in the U.S. This step ensures that the FDA has oversight of all devices available to consumers.

Who Must List Medical Devices?

• Manufacturers producing FDA-regulated medical devices.
• Repackagers and relabelers selling devices under their brand.
• Distributors placing medical devices into the U.S. market.

Why is Device Listing Critical?

• Customs Clearance – Avoid import holds and speed up shipments.
• Regulatory Compliance – Meet strict FDA labeling and safety standards.
• Market Confidence – Build trust with buyers and healthcare providers.

Why Choose IFC Global for FDA Compliance?

Navigating FDA regulations can be complex. IFC Global, a Miami-based, FDA-recognized U.S. Agent, ensures a seamless and compliant registration process, eliminating risks and delays.

Our services include:
✔ End-to-End Registration Support – We handle all paperwork for facility registration and device listings.
✔ Customs Compliance Assistance – Prevent costly detentions and import holds.
✔ Regulatory Expertise – Ensure your products meet all FDA safety and labeling standards.

Secure Your U.S. Market Access with IFC Global

Don’t risk delays or compliance issues. Partner with IFC Global for expert guidance and hassle-free FDA Medical Device Facility Registration and Device Listing.

Contact Us Today to start your FDA registration process!