10204 LICENSING PROCEDURES FOR DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS AND VENDORS

10204.1 License application forms may be obtained from the Department at 899 North Capitol Street, N.E., Washington, D.C., or online at www.hpla.doh.dc.gov.

10204.2 The application for licensure as a medical device distributor, manufacturer, initial importer, or vendor shall be signed and verified, and submitted on a license application form furnished by the Department.

10204.3 If the legal entity is a proprietorship, partnership, corporation, or association, the application shall contain the following:

(a) The name and residence address of the applicant, and the date and place of incorporation (if applicable);

(b) The name and address of the corporation’s registered agent and corporation charter number, or if any other type of association;

(c) The names of the principals of such association;

(d) The name of the legal entity to be licensed, including the name under which the business is conducted;

(e) The address of each place of business that is licensed;

(f) If a proprietorship, the name and residence address of the proprietorship;

(g) If a corporation, the date and place of incorporation and name and address of its registered agent in the state and corporation charter number; or

(h) If any other type of association, the names of the principals of such association;

(i) The name, residence address, and valid driver’s license number of each individual in an actual administrative capacity which, in the case of proprietorship, shall be the managing proprietor; partnership, the managing partner; corporation, the officers and directors; or those in a managerial capacity in any other type of association; and

(j) For each place of business, the residence address of the individual in charge;

10204.4 A completed application shall entitle a medical device distributor, manufacturer,

10204.5 initial importer, or vendor to a license, except as provided in § 10207.

The renewal application for licensure as a medical device distributor, manufacturer, initial importer, or vendor shall be made on a license application form furnished by the Department.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013); as amended by Final Rulemaking published at 63 DCR 13491 (October 28, 2016).