Ohio Administrative Code|Rule 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:
(1) Is an employee, or
			 immediate family member of an employee, of the department or the department of
			 health;
(2) Has a felony
			 conviction, an operating a vehicle while intoxicated conviction, or a
			 conviction for any crime involving dishonesty, deceit, or fraud.
(C) A manufacturer of an immobilizing or
		  disabling device, other than an ignition interlock device, shall request, in
		  writing, an application for certification from the department. The application
		  for certification shall be on a format prescribed by the director as listed in
		  paragraph (D) of rule 4501-45-11 of the Administrative Code.
(1) A manufacturer shall
			 file with the director a separate and complete application for certification
			 for each device model or type that differ in any aspect, together with all
			 documents required by the application, paragraphs (D) and (E) of this rule, and
			 the rules of this chapter.
(2) At the time a
			 manufacturer of an immobilizing or disabling device, other than an ignition
			 interlock device, files its application for certification with the director,
			 together with all documents required by the application and the rules of this
			 chapter, the manufacturer shall pay 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.
(3) The director shall
			 have the authority to 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 shall
			 pay all costs for the computerized criminal history.
(D) In addition to the completed
		  application, and all required documents, a manufacturer of an immobilizing or
		  disabling device, other than an ignition interlock device, shall file with the
		  director:
(1) 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;
(2) A copy of the
			 manufacturer's certificate of product liability insurance for the specific
			 device model or type, that is the subject of the manufacturer's
			 application for certification, which shall:
(a) Identify the manufacturer;
(b) Identify the department as an additional insured and
				certificate holder; 
(c) Identify the policy number;
(d) State a policy limit of at least one million dollars
				per occurrence;
(e) State the effective date and the expiration date of the
				policy;
(f) State that should the policy be cancelled before the
				expiration date, the issuing insurer will provide written notice to the
				department at least thirty days before cancellation of the policy.
(E) The director shall notify a
		  manufacturer, in writing, by certified mail, return 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 shall receive a certificate from the director. The
			 certificate shall be on a format prescribed by the director. Certification of
			 the specific immobilizing or disabling device, other than an ignition interlock
			 device, shall remain 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 shall add 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.
If a manufacturer of a certified immobilizing
			 or disabling device, other than an ignition interlock device, changes any of
			 the information published on the department's website, the manufacturer
			 shall immediately notify the department, in writing, and the department will
			 update its 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 shall
			 receive a written notice, by certified mail, return 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, makes any
		  modification(s) to a certified device model or type, the manufacturer shall
		  immediately notify the director, in writing by certified mail, return receipt,
		  of each modification and the reason(s) for the modification(s).
In addition to the notice, the manufacturer shall
		  provide the director with a complete copy of the testing protocol for the
		  modified device, and the results thereof, conducted by an independent testing
		  laboratory. The testing protocol, and results, shall be reviewed 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 (D)(2) 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 prior to the expiration date
		  stated on the certificate of liability insurance previously provided to the
		  director, the manufacturer shall provide the director with a copy of the
		  manufacturer's modified certificate of liability insurance coverage which
		  complies with all requirements set forth in paragraph (D)(2) of this rule by
		  certified mail, return receipt, postmarked no later than three days after the
		  date the modified product liability insurance becomes effective.
(I) If a manufacturer's product
		  liability insurance coverage for a certified immobilizing or disabling device,
		  other than an ignition interlock device, is cancelled by its insurer, or
		  terminated by the manufacturer prior to the expiration date stated on the
		  certificate of liability insurance previously provided to the director, the
		  manufacturer shall provide the director with a copy of the manufacturer's
		  new certificate of product liability insurance which complies with all
		  requirements set forth in paragraph (D)(2) of this rule, by certified mail,
		  return receipt, postmarked no later than three days after the manufacturer
		  received the notice of cancellation or termination.
(J) 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 paragraph (D)(2) and paragraphs (G) to (I) of
		  this rule, the director shall suspend or revoke the manufacturer's
		  certification(s) pursuant to rule 4501-45-05 of the Administrative Code. The
		  director shall notify the manufacturer of the certification suspension(s) or
		  revocation(s) by certified mail, return receipt.
(K) 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 shall remove 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.