US Japan MRAtext
US Japan MRAtext
US Japan MRAtext
The UNITED STATES OF AMERICA and JAPAN (hereinafter referred to as “the Parties”);
CONSIDERING the traditional friendly relations that exist between the Parties;
RECOGNIZING that such mutual recognition requires each Party to have confidence in
reliability of conformity assessment procedures of the other Party;
BEARING IN MIND the obligations of the Parties as Members of the World Trade Organization
(hereinafter referred to as the “WTO”), and being conscious, inter alia, of their obligations under
the Agreement on Technical Barriers to Trade included in Annex 1A (hereinafter referred to as
the “Agreement on Technical Barriers to Trade”), and the Agreement on Trade-Related Aspects
of Intellectual Property Rights included in Annex 1C (hereinafter referred to as the “Agreement
on Trade-Related Aspects of Intellectual Property Rights”), of the Marrakesh Agreement
Establishing the World Trade Organization (hereinafter referred to as the “WTO Agreement”);
and
RECOGNIZING that an agreement providing for mutual recognition of the results of conformity
assessment procedures is of particular interest to suppliers of equipment;
This Agreement establishes procedures for the acceptance by a Party of the results of conformity
assessment procedures conducted by conformity assessment bodies located in the territory of the
other Party for equipment within the scope of this Agreement, with the objective of facilitating
economic activity related to such equipment in and between the territories of the Parties.
ARTICLE 2 – DEFINITIONS
(a) the term “conformity assessment procedure” means a procedure to determine whether
equipment or a process complies with the Technical Regulations of a Party;
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(b) the term “conformity assessment body” means a body that conducts conformity
assessment procedures;
(c) the term “Technical Regulations” means relevant laws, regulations, and administrative
provisions of a Party set out in Section I of the Annex pertaining to technical requirements for
equipment, conformity assessment procedures, and the criteria for designation;
(d) the term “Designating Authority” means an authority of a Party identified in Section II of
the Annex with the power to designate, monitor, withdraw the designation of, suspend the
designation of, and remove the suspension of the designation of conformity assessment bodies
located in the territory of that Party;
(e) the term “designation” means the designation of a conformity assessment body in
accordance with Article 5 and the procedures set out in Section III of the Annex;
(f) the term “criteria for designation” means the criteria with which conformity assessment
bodies located in the territory of a Party must comply in order to obtain and maintain designation
by the Designating Authority of that Party, and that are set out in the Technical Regulations of
the other Party and the relevant ISO/IEC Guide and Standard set out in Section III of the Annex;
(g) the term “designated conformity assessment body” means a conformity assessment body
located in the territory of a Party designated by the Designating Authority of that Party in
accordance with Article 5 and the procedures set out in Section III of the Annex;
(h) the term “Regulatory Authority” means an authority of a Party identified in Section IV of
the Annex with the power to regulate the equipment within the scope of this Agreement with
respect to compliance with the Technical Regulations of that Party;
(i) the term “registration” means the registration of a conformity assessment body in
accordance with the procedures set out in Article 6;
(j) the term “registered conformity assessment body” means a conformity assessment body
registered in accordance with the procedures set out in Article 6;
(k) the term “results of conformity assessment procedures” means a determination, reached
through conducting conformity assessment procedures, of whether equipment or a process
complies with the Technical Regulations of a Party and includes certificates and marks of
conformity reflecting an affirmative determination; and
2. All terms used in this Agreement that are not defined in paragraph 1 have the meaning
assigned to them in the ISO/IEC Standard set out in Section V of the Annex.
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ARTICLE 3 – GENERAL PROVISIONS
2. Each Party shall accept, in accordance with this Agreement, the results of conformity
assessment procedures that a registered conformity assessment body located in the territory of
the other Party conducts for equipment within the scope of this Agreement that determine that
the equipment or a process associated with that equipment complies with the Technical
Regulations of the Party.
4. The Annex is an integral part of this Agreement and sets out the following:
(e) The ISO/IEC Standard for terms not defined in this Agreement;
(f) The equipment within the scope of this Agreement for each Party;
(a) make publicly available its Technical Regulations and any amendments it makes
thereto;
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(c) notify the other Party and provide corrected information on registered conformity
assessment bodies, if the information the Party has provided in a proposal to
register the conformity assessment body becomes inaccurate and the inaccuracy
could affect the operation of this Agreement; and
(d) notify the other Party if it names a Designating Authority or Regulatory Authority
other than the authority identified in Section II and IV of the Annex, respectively.
6. Each Party shall respond to inquiries from the other Party regarding:
(a) conformity assessment procedures within the scope of this Agreement and
Technical Regulations of the Party, including inquiries concerning the specific
article, annex, section, or part, of the Technical Regulations of the Party that is
applicable to such conformity assessment procedures;
(c) any proposed change in its Technical Regulations before it takes effect.
7. Each Party recognizes that cooperation with conformity assessment bodies is essential to
ensuring that conformity assessment bodies located in a territory of a Party understand and
comply with the criteria for designation, including the Technical Regulations of the other Party,
and to that end, should encourage training sessions and other exchanges of information with
conformity assessment bodies as a means to enhance their ability to benefit from this Agreement.
8. Each Party should also encourage conformity assessment bodies located in its territory to
include conformity assessment bodies located in the territory of the other Party in activities
organized to promote understanding of the Technical Regulations of the Party.
1. Each Party shall ensure that its Designating Authority identified in Section II of the
Annex has the necessary power to designate, monitor, conduct verification of, withdraw the
designation of, suspend the designation of, and remove the suspension of the designation of, the
conformity assessment bodies in its territory.
2. If a Party appoints one or more bodies to evaluate conformity assessment bodies, such
appointment shall not affect the obligations of the Designating Authority set out in this
Agreement.
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ARTICLE 5 – DESIGNATION
1. The Designating Authority of each Party shall apply the procedures set out in Section III
of the Annex in determining whether to designate conformity assessment bodies in its territory
for purposes of this Agreement.
2. Each Party shall ensure, through appropriate means such as audits, inspections, or
monitoring, that registered conformity assessment bodies in its territory comply with the criteria
for designation.
3. Each Party shall, on the request of the other Party, provide information to the other Party
on methods the Party uses to designate conformity assessment bodies.
ARTICLE 6 – REGISTRATION
1. The following procedures shall apply to the registration of a conformity assessment body:
(a) If a Party seeks to register a designated conformity assessment body under this
Agreement, the Party shall submit a proposal to the other Party and the Joint
Committee. The proposal shall be in writing and include (i) a proposed text of a
Joint Committee decision to register the conformity assessment body signed by
the proposing Party’s co-chair of the Joint Committee and (ii) the information for
registration of the conformity assessment body identified in Section VII of the
Annex.
(b) The Party receiving the proposal shall evaluate whether the conformity
assessment body complies with the criteria for designation. If the Regulatory
Authority of the receiving Party requires additional information to evaluate the
conformity assessment body’s compliance with the criteria for designation, it may
request the information from the proposing Party through the Designating
Authority of the proposing Party. A request for additional information under this
subparagraph shall suspend the 30-day period referred to in subparagraph (c) until
the date on which the receiving Party receives the information.
(c) Within 30 days after the date on which it receives a proposal referred to in
subparagraph (a), the receiving Party shall notify the proposing Party and the co-
chairs of the Joint Committee in writing whether it accepts or rejects the proposal,
in accordance with subparagraph (d) or (e), based on its evaluation of whether the
conformity assessment body complies with the criteria for designation.
(d) If the receiving Party accepts the proposal, that Party’s co-chair of the Joint
Committee shall sign the proposed text of the Joint Committee decision, which
shall then constitute a decision of the Joint Committee registering the conformity
assessment body. The receiving Party shall include a copy of the decision in its
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notification under subparagraph (c). The registration of the conformity
assessment body shall take effect on the date on which the receiving Party’s co-
chair of the Joint Committee signs the decision.
(i) the receiving Party shall include in its notification under subparagraph (c)
the reasons therefor, and
(ii) at the request of either Party, the Joint Committee shall discuss the matter
within 60 days after it receives notification under subparagraph (c). The
Joint Committee may request the proposing Party to verify whether the
conformity assessment body complies with the criteria for designation.
Paragraphs 2 and 3 of Article 9 shall apply mutatis mutandis to a
verification requested pursuant to this paragraph.
2. The receiving Party shall accept the results of conformity assessment procedures
conducted by a registered conformity assessment body located in the territory of the other Party
from the date of a decision of the Joint Committee registering the conformity assessment body
under paragraph 1(d).
1. Each Party shall ensure that its Designating Authority withdraws its designation of a
registered conformity assessment body when the Designating Authority determines that the
conformity assessment body no longer complies with the criteria for designation.
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results of conformity assessment procedures conducted by the conformity assessment body
before the date on which the Designating Authority of the Party suspended the designation of the
conformity assessment body.
ARTICLE 8 – CONTESTATION
1. If a Party considers that a registered conformity assessment body located in the territory
of the other Party does not comply with the criteria for designation, the Party may notify the
other Party and the co-chairs of the Joint Committee that it contests the conformity assessment
body’s compliance with the criteria for designation. The notification shall be in writing and
include the reasons for the contestation. The Joint Committee shall discuss the matter within 60
days after the date on which the Party makes the notification.
2. Thirty days after the date on which the Joint Committee receives a notification under
paragraph 1, the notification shall be considered to be a decision of the Joint Committee to
suspend the registration of the conformity assessment body, unless the Joint Committee decides
otherwise within the 30 days. The contesting Party shall accept the results of conformity
assessment procedures conducted by the conformity assessment body before the date of the
suspension.
3. The registration of the conformity assessment body shall remain suspended until the
contesting Party withdraws the contest or the Joint Committee decides to remove the suspension
of the registration of the conformity assessment body, whichever occurs first. The contesting
Party may withdraw the contest by notifying the other Party and the co-chairs of the Joint
Committee. A notification under this paragraph shall be considered to be a decision of the Joint
Committee to remove the suspension. The contesting Party shall accept the results of conformity
assessment procedures conducted by the conformity assessment body from the date of the
removal of the suspension.
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ARTICLE 9 –VERIFICATION
1. The Joint Committee may request a Party to verify whether a registered conformity
assessment body located in the territory of that Party complies with the criteria for designation.
The request shall be in writing and include the reasons for the request.
2. The requested Party shall conduct the verification in a timely manner. One or more
representatives of the Regulatory Authority of the other Party may, as appropriate, participate as
an observer in the verification, provided that, prior to the start of the verification, the conformity
assessment body agrees to such participation.
3. The requested Party shall promptly notify the other Party and the co-chairs of the Joint
Committee of the results of the verification.
1. The Parties hereby establish a Joint Committee composed of one or more representatives
of each Party. The Joint Committee shall be co-chaired by a representative of each Party as set
out in Section VIII of the Annex.
2. The Joint Committee shall have the authority to take decisions concerning:
5. The Joint Committee shall take decisions by agreement of the co-chairs of the Joint
Committee or as provided in this Agreement. All decisions of the Joint Committee shall be in
writing.
6. The Joint Committee may consider any matter related to the operation of this Agreement.
7. The Joint Committee shall confirm that each Party makes publicly available a list of
conformity assessment bodies that are registered under this Agreement.
8. The Joint Committee shall establish appropriate means, including relevant contact points,
for the Parties to exchange the information and respond to inquiries referred to in paragraphs 5
and 6 of Article 3 and paragraph 3 of Article 5.
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9. A Party may bring any question or concern it may have regarding the interpretation or
application of this Agreement to the Joint Committee, which shall seek to answer the question or
resolve the concern in a manner that is acceptable to the Parties.
The Regulatory Authority of a Party may request a registered conformity assessment body
located in the territory of the other Party to answer questions or provide information concerning
the results of conformity assessment procedures the conformity assessment body has conducted.
Responses by registered conformity assessment bodies to such requests shall be voluntary. The
Parties recognize that responses to such requests shall not affect the power of the Designating
Authority of the other Party. The Regulatory Authority of a Party shall notify the Designating
Authority of the other Party regarding requests made to the conformity assessment body under
this Article.
ARTICLE 12 – CONFIDENTIALITY
Each Party shall maintain, in accordance with its laws and regulations, the confidentiality of any
information provided to it as confidential in connection with the operation of this Agreement and
the disclosure of which would prejudice the legitimate commercial interests of particular
enterprises, public or private.
ARTICLE 13 – HEADINGS
The headings of the Articles of this Agreement are included for convenience of reference only
and shall not affect the interpretation of this Agreement.
1. Nothing in this Agreement shall require either Party to accept standards or technical
regulations of the other Party.
2. Nothing in this Agreement shall be construed to limit the authority of a Party to:
(a) determine the level of protection it considers appropriate with regard to health or
safety, including the safety and effectiveness of medical devices and radiological
health, the environment, or misleading or deceptive practices;
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(b) take such measures as it considers necessary to protect health or safety, including
with regard to the safety and effectiveness of medical devices and radiological
health, or the environment or to prevent misleading or deceptive practices; or
(c) take all other appropriate measures whenever it ascertains that particular
equipment does not meet its Technical Regulations or other laws, regulations, or
administrative provisions or policies governing such equipment.
3. Nothing in this Agreement shall be construed to affect the rights or obligations of either
Party under the WTO Agreement, including the Agreement on Technical Barriers to Trade or the
Agreement on Trade-Related Aspects of Intellectual Property Rights.
This Agreement shall enter into force on the first day of the second month following the date on
which the Parties exchange diplomatic notes informing each other that they have completed their
respective internal procedures necessary for the entry into force of this Agreement.
ARTICLE 16 – AMENDMENTS
1. This Agreement may be amended by agreement between the Parties. The Parties may
amend Section I, II, IV, V, or VIII of the Annex by agreement between the Government of the
United States and the Government of Japan through an exchange of diplomatic notes.
2. If there is any change in the laws or regulations of a Party that renders any of the
information set out in Section I, II, IV, or VIII of the Annex no longer accurate or complete, the
Party shall initiate, in a timely manner, an exchange of diplomatic notes between the
Government of the United States and the Government of Japan in accordance with paragraph 1
to revise the relevant Section.
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ARTICLE 17 – TERMINATION
Either Party may notify the other Party in writing of its intention to terminate this Agreement. If
a Party gives such notice, this Agreement shall terminate 180 days after the date on which the
other Party receives the notice.
IN WITNESS WHEREOF, the undersigned, being duly authorized, have signed this Agreement.
Done in duplicate at Washington, this sixteenth day of February, 2007 in the English and
Japanese languages, both texts being equally authentic.
For Japan:
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ANNEX
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Distributional Services
Part 78 Cable Television Relay
Service
Part 80 Stations in the Maritime
Services
Part 87 Aviation Services
Part 90 Private Land Mobile Radio
Services
Part 95 Personal Radio Services
Part 97 Amateur Radio Service
Part 101 Fixed Microwave Services;
and
3. Administrative provisions related to
the laws and regulations set out in
paragraphs 1 and 2.
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Section III: Procedures for Designating Conformity Assessment Bodies
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UNITED STATES JAPAN
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Section IV: Regulatory Authority
Section V: The ISO/IEC Standard for Terms Not Defined in this Agreement
ISO/IEC Standard 17000: 2004, Conformity Assessment – Vocabulary and General Principles
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Section VII: Information for Registration of Conformity Assessment Bodies
2. The equipment for which the 2. The equipment for which the
conformity assessment body is authorized conformity assessment body is authorized
to conduct conformity assessment to conduct conformity assessment
procedures (scope of designation); procedures (scope of designation);
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Section VIII: Co-chairs of the Joint Committee
For the United States, the co-chair of the For Japan, the co-chair of the Joint
Joint Committee shall be as follows: Committee shall be the Ministry of Foreign
Affairs for all functions.
1. For functions referred to in Articles
6 and 7 relating to registration, termination
of registration, suspension of registration,
and removal of suspension of registration
of, conformity assessment bodies located in
the territory of Japan: FCC
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