Bill > H3274

This bill establishes a licensing requirement for companies that repair medical devices in the Commonwealth, meaning that any corporation, LLC, or partnership engaged in repairing medical devices must obtain a license from the department, which is defined as a valid and current certificate of qualification. To qualify for a license, applicants must meet criteria set by the department, including the ability to satisfy "FDA standards for medical device manufacturers," which refers to regulations set by the Food and Drug Administration for making medical devices. Licensed companies, known as "licensees," will receive a certificate with their name and license number, and they must adhere to all federal, state, and local laws, notify the department of their business address and any changes, and renew their licenses annually at least 30 days before expiration. Failure to meet renewal requirements can lead to license expiration and revocation, and the department will maintain and publish a list of licensed companies. The department will also establish grounds for suspending or revoking licenses, such as not conforming to FDA standards or departmental rules, and will publicly announce such actions. Violating these provisions, including repairing devices without a license or providing false information to obtain one, can result in imprisonment or fines.