10424. FOREIGN MANUFACTURERS

10424 FOREIGN MANUFACTURERS 10424.1 Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with § 10510 of this subtitle. The designated agent accepts responsibility for the duties that such designation entails. Upon the effective date of these regulations, foreign manufacturers shall inform the Department, by letter, of the name and address of the agent designated under this section and § 10510 of this subtitle, and shall update this information as necessary. Such updated information shall be submitted to the Department, within five (5) days of a change in the designated agent information. 10424.2 Designated agents of foreign manufacturers are required to: (a) Report to the Department in accordance with §§ 10420, 10421, 10422, and 10423; (b) Conduct or obtain from the foreign manufacturer the necessary information regarding the investigation and evaluation of the event to comport with the requirements of § 10420; (c) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement; (e) Maintain complaint files in accordance with § 10410; and (f) Register, list, and submit premarket notifications in accordance with Chapter 105. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10424