(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.
(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 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.
(C)(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)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.
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.
(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,
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
shall receive
receives 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
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 shall add
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.
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
receives
a written notice
, by certified mail, return
receipt,
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).,
other than an ignition interlock device,
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.
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)
(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
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
or new 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
within thirty 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)(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
paragraph (D)(2) and paragraphs
(C)(1) and (F)(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)(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
shall remove
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.
