# 21 CFR § 812.18: Import and export requirements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-812.18

## Section

- **Citation:** 21 CFR § 812.18
- **Heading:** Import and export requirements
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS > Subpart A—General Provisions

## Text

(a) Imports. In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation.
(b) Exports. A person exporting an investigational device subject to this part shall obtain FDA's prior approval, as required by section 801(e) of the act or comply with section 802 of the act.
[45 FR 3751, Jan. 18, 1980, as amended at 62 FR 26229, May 13, 1997]

## Nearby sections

- [21 CFR § 812.1 § 812.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.1.md)
- [21 CFR § 812.2 § 812.2 Applicability.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.2.md)
- [21 CFR § 812.3 § 812.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.3.md)
- [21 CFR § 812.5 § 812.5 Labeling of investigational devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.5.md)
- [21 CFR § 812.7 § 812.7 Prohibition of promotion and other practices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.7.md)
- [21 CFR § 812.10 § 812.10 Waivers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.10.md)
- [21 CFR § 812.18 § 812.18 Import and export requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.18.md)
- [21 CFR § 812.19 § 812.19 Address for IDE correspondence.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.19.md)
- [21 CFR § 812.20 § 812.20 Application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.20.md)
- [21 CFR § 812.25 § 812.25 Investigational plan.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.25.md)
- [21 CFR § 812.27 § 812.27 Report of prior investigations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.27.md)
- [21 CFR § 812.28 § 812.28 Acceptance of data from clinical investigations conducted outside the United States.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.28.md)
- [21 CFR § 812.30 § 812.30 FDA action on applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.30.md)
- [21 CFR § 812.35 § 812.35 Supplemental applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.35.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-812.18. Check the current official text before relying on it. Not legal advice.