Does an imported medical device or drug need FDA registration?

Part 207 reaches foreign manufacturers, repackers, relabelers, and salvagers of human drugs, unless they fall in one of the exempt classes in section 207.13. A covered establishment registers with FDA and lists its drugs. This is establishment registration and drug listing — an identification requirement — and the rule is explicit that it does not relieve anyone of other statutory or regulatory obligations.

For devices, the owner or operator of an establishment that manufactures, prepares, or processes a device intended for human use registers and submits a device list, unless exempt under section 807.65. Part 807 also names the U.S. initial importer as a party that registers. An initial importer may fulfill its listing obligation, for a device it did not design or relabel, by submitting the manufacturer's name and address rather than full listing information.

Part 807 defines the initial importer as the importer that furthers the marketing of a device from a foreign manufacturer to the person who makes the final sale, without repackaging or relabeling it (§ 807.3(g)). That party registers its establishment. Registration and listing go through FDA's electronic device registration and listing system (§ 807.21), and the foreign establishment that makes the device registers and lists as well (§ 807.40).

The calendar matters. Annual registration runs from October 1 through December 31 of each FDA fiscal year; updates to registration information are due within 30 days of a change; and device listings are reviewed and updated in that same October-to-December window (§ 807.21). A lapsed listing is the kind of gap that surfaces at entry rather than in the office.

Registration and listing are an identity-and-inventory step, not a quality verdict. The rule states plainly that registration and listing do not amount to FDA approval, clearance, or a determination that a product is safe or even that it is a device. A separate premarket pathway — approval for a drug, or clearance or approval for a device — can still apply and is a different question entirely.

These two requirements cover drugs and medical devices. Cosmetics, food, and other product types answer to different FDA rules, so a product that is not a drug or a device is not addressed by Part 207 or Part 807 — which does not mean it is free of FDA requirements, only that the answer lies elsewhere.