10905. IMPORT AND EXPORT REQUIREMENTS

10905 IMPORT AND EXPORT REQUIREMENTS 10905.1 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 act as the agent of the foreign exporter and the sponsor of the investigation. 10905.2 A person exporting an investigational device subject to this section shall obtain Department prior approval, as required by Chapter 103 of this title or comply with the Act. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10905