6268933 Health, Department of - Notice of Final Rulemaking - Licensing importers and vendors of medical devices
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DEPARTMENT OF HEALTH
NOTICE OF FINAL RULEMAKING
The Director of the Department of Health, pursuant to the authority set forth in Sections 4902(a) (8) and 4908 of the Department of Health Functions Clarification Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code §§ 7-731(a)(8) and 7-737 (2012 Repl. & 2016 Supp.)), and Mayor’s Order 2006-34, dated March 12, 2006, hereby gives notice of the adoption of the following amendments to Chapters 102 (Licensing of Medical Device Distributors and Manufacturers), 105 (Establishment, Registration, and Device Listing for Manufacturers and Initial Importers of Devices), and 106 (Premarket Approval of Medical Devices) of Title 22 (Health), Subtitle B (Public Health and Medicine) of the District of Columbia Municipal Regulations (DCMR).
Section 4902(a)(8) of the Department of Health Functions Clarification Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731(a)(8) (2012 Repl. & 2016 Supp.)) authorizes the Department of Health to regulate medical devices in the District of Columbia. The Notice of Final Rulemaking published on July 12, 2013 in the D.C. Register at 60 DCR 10251 only required manufacturers and distributors to be licensed and regulated by the Department of Health. However, there are four business entities that are involved in the supply of medical devices in the District of Columbia – manufacturers, distributors, initial importers, and vendors.
On July 24, 2015 at 62 DCR 010043, and July 22, 2016 at 63 DCR 009708, the Department of Health published Notices of Proposed Rulemaking in the D.C. Register that added initial importers and vendors of medical devices as business entities that are required to be licensed. No comments were submitted in response to this Proposed Rulemaking during the thirty (30)-day comment period and no changes have been made. These rules were adopted as final on June 20, 2016 and will become effective upon publication in the D.C. Register.
Title 22-B DCMR, PUBLIC HEALTH AND MEDICINE, is amended as follows:
Chapter 102, LICENSING OF MEDICAL DEVICE DISTRIBUTORS AND MANUFACTURERS, is amended as follows:
The Chapter 102 heading is amended to read as follows:
CHAPTER 102 LICENSING OF MEDICAL DEVICES – DISTRIBUTORS,
MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS
Section 10200, GENERAL PROVISIONS, is amended as follows:
Subsection 10200.1 is amended to read as follows:
10200.1 These sections provide for the minimum licensing standards necessary to ensure the safety and efficacy of medical devices placed in the stream of commerce by distributors, manufacturers, initial importers, and vendors.
Section 10203, LICENSURE REQUIREMENTS, is amended as follows:
The section heading for 10203 is amended to read as follows:
10203 LICENSURE REQUIREMENTS FOR DISTRIBUTORS,
MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS
Subsections 10203.1 to 10203.6 are amended to read as follows:
10203.1 Except 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.
10203.2 The license shall be displayed in an open public area at each place of business.
10203.3 Each 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.
10203.4 Each 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.
10203.5 If 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.
10203.6 The Department may license a distributor, manufacturer, initial importer, or vendor of medical devices who meets the requirements of these sections and pays all fees.
Subsection 10203.14 is amended to read as follows:
10203.14 If 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.
Section 10204, LICENSING PROCEDURES, is amended as follows:
The section heading for 10204 is amended to read as follows:
10204 LICENSING PROCEDURES FOR DISTRIBUTORS, MANUFACTURERS,
INITIAL IMPORTERS AND VENDORS
Subsections 10204.1 and 10204.2 are amended to read as follows:
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.
Subsection 10204.4 is amended to read as follows:
10204.4 A completed application shall entitle a medical device distributor, manufacturer, initial importer, or vendor to a license, except as provided in § 10207.
A new Subsection 10204.5 is added to read as follows:
10204.5 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.
Subsection 10204.6 is repealed.
Section 10207, REFUSAL, CANCELLATION, SUSPENSION, OR REVOCATION OF LICENSE, is amended as follows:
Subsections 10207.3 and 10207.4 are amended to read as follows:
10207.3 The Department may, after providing opportunity for a hearing, refuse to license a distributor, manufacturer, initial importer, or vendor of medical devices, or may suspend or revoke a license, for any violation of the federal-law requirements incorporated into these regulations pursuant to § 10201.
10207.4 A license issued under this chapter shall be returned to the Department if the medical device distributor, manufacturer, initial importer, or vendor’s place of business:
(a) Ceases business or otherwise ceases operation on a permanent basis;
(b) Relocates; or
(c) Is deemed, as a corporation, to have undergone an ownership change as determined by a transfer of five percent (5%) or more of the share of stock from one person to another.
Section 10208, MINIMUM STANDARDS FOR LICENSURE, is amended as follows:
Subsection 10208.1 is amended to read as follows:
10208.1 All medical device distributors, manufacturers, initial importers, or vendors engaged in the design, manufacture, packaging, labeling, storage, installation, servicing, and vending of medical devices shall comply with the minimum standards of this section.
Subsections 10208.3 and 10208.4 are repealed.
Subsection 10208.6 is amended to read as follows:
10208.6 No manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of medical devices by distributors, manufacturers, initial importers, or vendors shall be conducted in any personal residence.
Subsection 10208.8 is amended to read as follows:
10208.8 All medical devices stored by distributors, manufacturers, initial importers, or vendors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the label of such medical devices.
Subsection 10208.9 is amended to read as follows:
10208.9 Medical devices distributed by device distributors, manufacturers, initial importers, or vendors shall meet the labeling requirements of Chapter 103 of this subtitle.
Subsection 10208.12 is amended to read as follows:
10208.12 Medical device distributors, manufacturers, initial importers, or vendors shall meet the applicable medical device reporting requirements of Chapter 104 of this subtitle.
Subsection 10208.14 is repealed and reserved.
Subsection 10208.15 is amended to read as follows:
10208.15 Each medical device distributor, manufacturer, initial importer, or vendor who distributes prescription medical devices shall maintain a record for every prescription medical device, showing the identity and quantity received or manufactured and the disposition of each device.
Subsection 10208.16 is amended to read as follows:
10208.16 Each medical device distributor, manufacturer, initial importer, or vendor who delivers a prescription medical device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device.
A new Section 10299 is added to read as follows:
10299 DEFINITIONS
10299.1 As used in this chapter, the following terms shall have the meanings ascribed:
Initial importer – any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package. The term “initial importer” does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.
Vendor – any person, with the exception of any agent or sale representative of a licensed manufacturer or distributor, engaged in selling medical devices for the immediate delivery upon purchase.
Chapter 105, ESTABLISHMENT, REGISTRATION, AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES, Section 10500, WHO MUST REGISTER AND SUBMIT A DEVICE LIST, is amended as follows:
A new Subsection 10500.6 is added to read as follows:
10500.6 For purposes of these chapters, the term “device(s)”, wherever it appears, shall mean “medical device(s).”
Section 10599, DEFINITIONS, Subsection 10599.1, is amended as follows:
The following definition is amended:
Initial importer – any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package. The term “initial importer” does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.
The following definitions are added:
Medical device – an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory:
(a) Which is:
(1) Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
(2) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or
(3) Intended to affect the structure or any function of the body of man or
other animals; and
(b) Which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Vendor – any person, with the exception of an agent or sales representative of a licensed manufacturer or distributor, engaged in selling medical devices for the immediate delivery upon purchase.
Chapter 106, PREMARKET APPROVAL OF MEDICAL DEVICES, Section 10699, DEFINITIONS, is amended as follows:
Subsection 10699.1 is amended to include the following definition:
Initial importer – any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package. The term “initial importer” does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.
