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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B102. LICENSING OF MEDICAL DEVICES - DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS |
Section 22-B10203. LICENSURE REQUIREMENTS FOR DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS
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10203.1Except as provided by § 10202, a person may not engage in distributing, manufacturing, importing, or vending medical devices in the District of Columbia unless the person has a valid license from the Department of Health.
10203.2The license shall be displayed in an open public area at each place of business.
10203.3Each person engaged in distributing, manufacturing, importing, or vending of medical devices in the District of Columbia on the effective date of these sections shall apply for a medical device distributor, manufacturer, initial importer, or vendor license no later than sixty (60) days following the effective date of these regulations.
10203.4Each person acquiring or establishing a place of business for the purpose of medical device distribution, manufacturing, importation, or vending after the effective date of these subsections shall apply to the Department for a license prior to beginning operation.
10203.5If the medical device distributor, manufacturer, initial importer, or vendor operates more than one place of business, the medical device distributor, manufacturer, initial importer, or vendor shall obtain a license for each place of business.
10203.6The Department may license a distributor, manufacturer, initial importer, or vendor of medical devices who meets the requirements of these sections and pays all fees.
10203.7Licenses shall not be transferable from one (1) person to another or from one (1) place of business to another.
10203.8Unless a license is amended pursuant to this section or revoked or suspended as provided in § 10207 (relating to Refusal, Cancellation, Suspension, or Revocation of a License), the license shall be valid for two (2) years.
10203.9The license application as outlined in § 10204.2 of this chapter (relating to Licensing Procedures) and non-refundable licensing fees for each place of business shall be submitted to the department prior to the expiration date of the current license. A person who files a renewal application after the expiration date must pay an additional one hundred dollars ($100) as a delinquency fee.
10203.10A licensee who fails to submit a renewal application prior to the current license expiration date and continues operations may be subject to the enforcement and penalty provision in § 10210 (relating to Enforcement and Penalties), or the revocation and suspension provisions in § 10207.
10203.11A renewal license shall only be issued when all past due fees and delinquency fees are paid.
10203.12A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business, shall require submission of an application as outlined in § 10204 (relating to Licensing Procedures) and submission of fees.
10203.13Not fewer than thirty (30) days in advance of the change, a licensee shall notify the Director or the Director’s designee in writing of the licensee’s intent to change the location of a licensed place of business. The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location. Not more than ten (10) days after the completion of the change of location, the licensee shall notify the Director or the Director’s designee in writing to verify the change of location, the specific date of change, the new location, the address of the new location, and the name and residence address of the individual in charge of the business at the new address. Notice shall be deemed adequate if the licensee provides the intent and verification notices to the Director or the Director’s designee by certified mail, return receipt requested, mailed to the Department, 899 North Capitol Street, N.E., Washington, D.C. 20002.
10203.14If the United States Food and Drug Administration (FDA) determines, with respect to a product that is a combination of a drug and a medical device, that the primary mode of action of the product is as a device, a distributor, manufacturer, initial importer, or vendor of the product is subject to licensure as described in this section.