Section 4501-45-02 - Certification requirements for immobilizing or disabling devices other than ignition interlock devices(A) A manufacturer of an immobilizing or disabling device, other than an ignition interlock device, shall obtain certification from the director for each device model or type that differ in any aspect, prior to leasing, selling, or otherwise using its device(s) in this state.(B) A manufacturer of an immobilizing or disabling device, other than an ignition interlock device, may not be eligible for certification of its device(s) if the manufacturer, including, but not limited to the owner(s), officers, partners, members, agents, employees, contractors, or installers, who work in Ohio, is an employee, or immediate family member of an employee of the department of health. (C) A manufacturer of an immobilizing or disabling device, other than an ignition interlock device, shall not be eligible for certification of its device(s) if the manufacturer, including, but not limited to, the agents, employees, contractors, or installer(s), who work in Ohio, has plead guilty to, or been convicted of, any disqualifying offense in paragraph (C)(10)(a) to (C)(10)(d) in rule 4501-45-05 of the Administrative Code. A manufacturer of an immobilizing or disabling device may not be eligible for certification of its device(s) if the manufacturer, including, but not limited to, the agents, employees, contractors, or installer(s), who work in Ohio, has plead guilty to, or been convicted of, any disqualifying offense in paragraphs (C)(10)(e) to (C)(10)(t) in rule 4501-45-05 of the Administrative Code.
(D) A manufacturer of an immobilizing or disabling device, other than an ignition interlock device, shall submit an "Application for Certification for Immobilizing or Disabling Devices other than ignition Interlock Devices" (OTS 0027).(1) A manufacturer shall file a separate application for certification for each device model or type that differ in any aspect. The applications includes: (a) A complete copy of the testing protocol for the specific device model or type that is the subject of the manufacturer's application for certification, and the results thereof, conducted by an independent testing laboratory. The testing protocol, and the results, shall be reviewed and approved by the director of health;(b) A copy of the manufacturer's certificate of product liability insurance for the specific device model or type, which: (i) Identifies the manufacturer;(ii) Identifies the department as an additional insured and certificate holder;(iii) Identifies the policy number;(iv) States a policy limit of at least one million dollars per occurrence;(v) States the effective date and the expiration date of the policy; and(vi) States that should the policy be canceled before the expiration date, the issuing insurer will provide written notice to the department at least thirty days before cancellation of the policy.(c) A certification fee of one hundred dollars, in the form of a check or money order, payable to the treasurer of the state of Ohio. The certification fee is non-refundable.(2) The director may request a computerized criminal history for any person identified in a manufacturer's application for certification or any person identified in any document filed with the application. The manufacturer pays all costs for the computerized criminal history. (E) The director shall notify a manufacturer by electronic mail, acknowledged receipt, whether certification of the immobilizing or disabling device, other than an ignition interlock device, which is the subject of the manufacturer's application is granted or denied. (1) If certification is granted, a manufacturer receives a certificate from the director, on a format prescribed by the director. Certification of the specific immobilizing or disabling device, other than an ignition interlock device, remains in effect unless the director suspends or revokes the certification pursuant to rule 4501-45-05 of the Administrative Code. When the director issues a certificate to a manufacturer of an immobilizing or disabling device, other than an ignition interlock device, the department adds the certified device model or type, together with the manufacturer's name, business address, and contact information, to the department's list of licensed manufacturers of ignition interlock devices and certified devices published on the department's website.
(2) The director shall deny certification of an immobilizing or disabling device, other than an ignition interlock device, for any reason(s) set forth in rule 4501-45-05 of the Administrative Code. If certification is denied, a manufacturer receives a written notice by electronic mail, acknowledged receipt, from the director stating the reason(s) certification was denied.(F) If a manufacturer of an immobilizing or disabling device, other than an ignition interlock device, changes any information published on the department's website, the manufacturer shall submit an "Ohio Service Center Application/Removals/Updates" (OTS 0023). If the manufacturer makes any modification(s) to a certified device model or type, the manufacturer shall immediately submit the "Application for Certification for Immobilizing or Disabling Devices other than ignition Interlock Devices."The "Application for Certification for Immobilizing or Disabling Devices other than ignition Interlock Devices" includes: (1) Each modification and the reason(s) for the modification(s).(2) The director may request a complete copy of the testing protocol and the results for the modified device, conducted by an independent testing laboratory and approved by the director of health. The director shall determine whether the certification in effect at the time of the notice of modification(s) applies to the modified immobilizing or disabling device, other than an ignition interlock device, or the manufacturer must apply for a separate certification of the modified device. The director shall notify the manufacturer of the decision by certified mail, return receipt.
(G) A manufacturer of an immobilizing or disabling device, other than an ignition interlock device, shall obtain product liability insurance coverage for each device model or type that differ in any aspect prior to filing its application for certification with the director. The manufacturer's product liability insurance coverage shall meet the requirements set forth in paragraph (C)(1)(b) of this rule.(H) If a manufacturer's product liability insurance for a certified immobilizing or disabling device, other than an ignition interlock device, is modified, canceled, or terminated prior to the expiration date , the manufacturer shall provide the director with a copy of the manufacturer's modified or new certificate of liability insurance coverage which complies with all requirements set forth in this rule within thirty days . (I) If a manufacturer of a certified immobilizing or disabling device, other than an ignition interlock device, allows any time lapse in its product liability insurance coverage, or fails to provide all documents required by paragraphs (C)(1) and (F) of this rule, the director shall suspend or revoke the manufacturer's certification(s) pursuant to rule 4501-45-05 of the Administrative Code. (J) If a manufacturer's certification(s) of its immobilizing or disabling device(s), other than an ignition interlock device, is suspended or revoked pursuant to rule 4501-45-05 of the Administrative Code, the director removes the manufacturer's name, business address, contact information, and certified device(s) from the department's list of licensed manufacturers of ignition interlock devices and certified devices published on the department's website.Ohio Admin. Code 4501-45-02
Effective: 5/1/2024
Five Year Review (FYR) Dates: 1/10/2024 and 03/01/2029
Promulgated Under: 119.03
Statutory Authority: 4510.43
Rule Amplifies: 4510.43
Prior Effective Dates: 12/31/2010, 04/01/2016