FDA Medical device Listing

Medical Device as defined by the US FDA

In the United States, a medical device is defined in Section 201(h) of the FD&C Act as:

Section 201(h)
Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory.

FDA Medical Device Classification and Registration method

In the United States, the classification system for in vitro diagnostic medical devices is classified into Class I, II, and III according to the level of risk in consideration of safety and effectiveness, just like medical devices (MDD).

Establishment Registration required by FDA

It is a regulatory procedure similar to Korea's "business license," and in order to distribute medical devices for sale or lease in the United States, manufacturers and importers must register facilities related to the production and distribution of medical devices with the FDA according to the [21CFR 807 Subpart B/C] procedure.

• Information required for manufacturer registration: manufacturer's business name, address, contact information / US agent's business name, address, contact information / US importer's business name, address, and contact information
• After completing the manufacturer registration, before registering the product, the importer who wants to import the product must also be separately registered through Initial importer Registration.

FDA Establishment Registration target

• Manufacturer(both domestic and foreign)
• Re-packer & Re-labeller

FDA Establishment Registration checklist

• Medical device manufacturer establishment registration does not mean approval of establishment and products, so even if establishment registration is completed, approval for establishment and products must be carried out separately.
• Plants and establishment are not required to be registered prior to proceeding with a 510(k) or PMA, but must be registered at least 30 days prior to device sale.

FDA Class I Device Registration

• Class I products are a concept of registration, not a license, because of the low risk of the product.
• Manufacturer and importer registration, product registration is required, and registration is performed in accordance with the general regulations stipulated by the FDA.

FDA Class I Device Registration target

• Class I Medical Device Manufacturer(both domestic and foreign)
• Class I Re-packer & Re-labeller
• Class I Importer

FDA Class I Device Registration process

FDA Establishment Registration Checklist

• Search and check Class, Product Code, SE(Substantial equivalence)
• Establishment Registration agency
• Product Registration Agency
• Product label consulting
• US Agent acting
• Annual Registration Service

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