D.C. Mun. Regs. tit. 22, r. 22-B10424

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10424 - 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.

D.C. Mun. Regs. tit. 22, r. 22-B10424

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.