Chapter 111N of the General Laws is hereby amended by adding the following section:-
Section 9. SECTION 2. Said chapter 111, as appearing in the 2012 Official Edition, is hereby amended by inserting after section 31E the following section:-
Section 31F. (a) As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:—
“FDA standards for medical device manufacturers”, regulations promulgated by the Food and Drug Administration pursuant to the Federal Food Drug and Cosmetic Act for the manufacture of medical devices including those regulations set forth in 21 C.F.R. Parts 800 to 1299, inclusive.
“License”, a valid and current certificate of qualification issued by the department which shall medical device repair companies authority to engage in the repair of medical devices in the commonwealth.
“Licensee”, a medical device repair company holding a license issued by the department pursuant to this section.
“Medical device repair corporation”, a corporation, LLC or partnership engaged in the practice of repairing medical devices in the commonwealth.
(b) No medical device repair corporation shall repair medical devices or engage in the practice of repairing medical devices in the commonwealth unless issued a license pursuant to this section. Licenses issued under this section shall be granted to corporations meeting the criteria for qualification as established by this section and the department.
(c) License certificates bearing the licensee's name, license number, and the calendar year in which the license is valid shall be issued to all qualified licensees.
(d) All licensees shall abide by all federal, state, and local laws and ordinances. No license issued by the department may be sold or transferred.
(e) Every licensee shall notify the department of the address of the name and address of business. Licensees shall give immediate notice to the department of any change in this information. Service of any process shall be achieved by mailing notice of such information by first class postage, U.S. Postal Service, to the address of record. No further service of process shall be required.
(f) All applicants for licenses or license renewals shall be required to complete specific application forms developed and provided by the department.
(g) All required fees and documentation shall accompany any application form filed with the department.
(h) The department shall approve the issuing of a license to each applicant meeting the qualifications as set forth by the department, or deny a license to each applicant not meeting the qualifications as set forth by the department.
(i) The department shall develop eligibility requirements to be met by applicants seeking licensing by the department. The minimum application requirements shall include, but are not limited to, the applicant’s ability to satisfy the FDA standards for medical device manufacturers.
(j) The department shall maintain an official list of licensees and publish the list on its website.
(k) A license is only valid during the calendar year indicated on the license. At the end of that calendar year, the license will expire unless it is renewed by the licensee. All licensees shall make application for license renewal at least 30 days prior to the expiration of a current license.
(l) License renewal application forms and license renewal requirements shall be developed by the department.
(m) Failure to meet renewal requirements shall result in expiration and revocation of a license. Upon expiration of a license, the licensee's name shall be removed from the department’s official list.
(n) The department shall establish criteria for circumstances warranting the suspension or revocation of a license and establish the procedures for suspension or revocation of licenses. These circumstances shall include, but not be limited to, failure to conform with the FDA standards for medical device manufacturers and failure to follow the rules and regulations of the department.
The department shall take appropriate action to enforce the rules adopted with regard to license suspension or revocation. After suspension or revocation of a license, the department shall publish this information to the public.
(o) Whoever repairs or attempts to repair a medical device without first having obtained and having possession of a current, valid license from the department or who knowingly presents or files false information with the department for the purpose of obtaining a license or otherwise fraudulently obtains a license, or who knowingly violates any provision of this section shall be punished by imprisonment in the house of correction for not more than 2½ years or by a fine of not more than $20,000 or by both.
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