Section 22-B10510. ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR U.S. AGENTS OF FOREIGN MANUFACTURERS OF DEVICES

 

10510.1Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register and list such devices in conformance with the requirements in 21 C.F.R. § 807.20, et seq., unless the device enters a foreign trade zone and is re-exported from that foreign trade zone without having entered U. S. commerce. The official correspondent for the foreign establishment shall facilitate communication between the foreign establishment's management and representatives of the Department of Health for matters relating to the registration of device establishments and the listing of device products.

 

10510.2Each foreign establishment required to register under § 10510.1 of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with 21 C.F.R. § 807.20, et seq.  Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.
 

10510.3The United States agent shall reside or maintain a place of business in the United States.
 

10510.4Upon request from the Department, the United States agent shall assist DOH in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist the Department in scheduling inspections of the foreign establishment. If the agency is unable to contact the foreign establishment directly or expeditiously, the Department may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
 

10510.5The foreign establishment or the United States agent shall report changes in the United States agent's name, address, or phone number to the Department within ten (10) business days of the change.

 

10510.6No device may be imported or offered for import into the United States unless it is the subject of a device listing as required under 21 C.F.R. § 807.20, et seq. and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment; however, this restriction does not apply to devices imported or offered for import under the investigational use provisions of  this chapter or to a component, part, or accessory of a device or other article of a device imported under the Act.  The establishment registration and device listing information shall be in the English language.

 

 

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.

source

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