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Laws & Regulations Database of The Republic of China (Taiwan)

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1.Signed on December 07, 2017 Entered into force on December 07, 2017
This Mutual Recognition Arrangement (MRA) is entered into by and

(TECO), hereinafter referred to as “ TECO, ”

- and -

referred to as “ MECO, ”

WHEREAS, on 12 February 2009, the TECO and MECO signed a
Memorandum of Understanding on cooperation in the field of
Standardization and Conformity Assessment stating that any
arrangements therein will be implemented by the Bureau of
Standards, Metrology and Inspection (BSMI) of the Ministry of
Economic Affairs of Taiwan and the Bureau of Philippine
Standards (BPS) of the Department of Trade and Industry of the

WHEREAS, relative to the MOU, a Letter of Intent (LOI) was
likewise issued reflecting both Parties ’ desire to determine
the feasibility of establishing an appropriate and effective
cooperation framework for negotiating MRA;

WHEREAS, in line with the said MOU and LOI, greater
international harmonization of standards and technical
regulations is further encouraged;

NOW, THEREFORE, this Mutual Recognition Arrangement on
Conformity Assessment for Industrial Products is hereby executed
and entered into in recognition of the Parties ’ shared
commitments to protect inter alia the environment and the life,
health and safety of humans, animals and plants and shall be
implemented by BSMI for TECO and BPS for MECO.


Section 1. Objectives – The general objectives of this
Arrangement are as follows:
1.1 To enhance cooperation through information exchange between
the Parties to ensure safety and quality of products covered
by this Arrangement;
1.2 To facilitate trade between the Parties through the mutual
recognition of the results of conformity assessment
activities issued by the designated Conformity Assessment
Bodies required for access into their respective markets;
1.3 To affirm the Parties ’ commitments to the Agreement on
Technical Barriers to Trade (TBT) of the World Trade
Organization (WTO).

Section 2. Definitions – All general terms concerning standards
and conformity assessment used in this Arrangement
shall adopt the definitions provided in the ISO/IEC
Guide 2:2004 “ Standardization and Related
Activities – General Vocabulary ” and ISO/IEC
17000:2004 “ Conformity Assessment – Vocabulary and
General Principles ” published by the International
Organization for Standardization and International
Electrotechnical Commission (ISO/IEC), unless the
contrary requires otherwise.

In addition, for purposes of this Arrangement, the
following shall mean –

2.1 Accept - The use of the results of conformity assessment as
a basis for regulatory actions such as approval, licences,
registrations and post market assessments of conformity;
2.2 Conformity Assessment - Any activity which involves
determining directly or indirectly that relevant Mandatory
Requirements are fulfilled;
2.3 Conformity Assessment Body - A body that conducts conformity
assessment activities including testing laboratories, and
inspection bodies;
2.4 Designating Authority - A body as specified in this
Arrangement established in the territory of a Party with the
necessary authority to designate, monitor, suspend, lift
suspension or withdraw designation of Conformity Assessment
Bodies within its jurisdiction;
2.5 Designation - The authorization issued by a Designating
Authority to a Conformity Assessment Body to undertake
specified conformity assessment activities;
2.6 Inspection Body - A body that may be designated in
accordance with this Arrangement to conduct inspection and
sampling pursuant to the relevant Mandatory Requirements;
2.7 Mandatory Requirements – Legislative, regulatory and
administrative requirements of the Party into which the
product is being supplied that are subject of this
2.8 Regulatory Authority - An entity that exercises a legal
right to control the import, use or supply of products
within a Party ’ s jurisdiction and may take enforcement
action to ensure that products marketed within its
jurisdiction comply with that Party ’ s Mandatory
2.9 Stipulated Requirements - The criteria set out for the
designation of Conformity Assessment Bodies;
2.10 Testing Laboratories - Independent laboratories or
government testing bodies that may be designated by one
Party ’ s Designating Authority in accordance with this
Arrangement to undertake tests to the other Party ’ s
Mandatory Requirements.

Section 3. Scope of the MRA – The MRA shall cover the following
3.1 Industrial products manufactured in the Parties ’
territories that are specified, by agreement of the
Regulatory Authorities, under Annex I on which either Party
has prescribed Mandatory Requirements applicable to imports
as set out in the applicable laws, regulations and
administrative provisions listed in Annex II except for the
3.1.1 Telecommunication equipment; and
3.1.2 Medical devices.
3.2 Duly designated Testing Laboratories and Inspection Bodies.
3.3 Third party conformity assessment activities particularly
testing by accredited testing laboratories and inspection
and sampling by accredited inspection bodies.


Section 1. Obligations of the Parties – TECO and MECO are
obliged as follows:
1.1 To exchange information concerning their Mandatory
Requirements, conformity assessment procedures and regimes
covered in this Arrangement;
1.2 To inform the other Party of any proposed changes to its
Mandatory Requirements at least sixty (60) calendar days
before the changes enter into force, except where
considerations of health, safety and environmental
protection warrant more urgent action;
1.3 To ensure that their Designating Authorities have the
necessary authority and competence to carry out their
obligations within their respective jurisdictions as stated
in this Arrangement;
1.4 To ensure that their designated and recognized Conformity
Assessment Bodies are available for verification of their
technical competence and compliance with the relevant
Stipulated Requirements;
1.5 To accept results of conformity assessment activities
stipulated herein that demonstrate compliance with their
respective Mandatory Requirements when the conformity
assessment activities are undertaken by Conformity
Assessment Bodies designated by BPS and recognized by BSMI
and vice versa in accordance with Articles II and III of
this Arrangement. Upon receipt of the results, BPS or BSMI,
shall complete the relevant product approval processes
within ten (10) working days;
1.6 When requested, to make copies of their Mandatory
Requirements, and intended changes thereto, available in
1.7 To give consideration to any request for consultations on
issues relating to the interpretation and implementation of
this Arrangement. Such consultations shall take place within
sixty (60) calendar days after the date of the receipt of
the request with the objective of finding mutually
acceptable solutions. One or more consultation/s may be
convened and conducted through a method as may be agreed

Section 2. Designating Authorities – The BSMI and BPS, in their
capacity as designating authorities shall consult, as
necessary, with their counterparts to ensure the
maintenance of confidence in conformity assessment
processes and procedures. This consultation may
include joint participation in audits related to
conformity assessment activities or assessments of
designated Conformity Assessment Bodies, where such
participation is appropriate, technically possible
and within reasonable cost.

Section 3. Basis for Designating Conformity Assessment Bodies
(CABs) – The Designating Authorities shall consider
the following in designating a CAB:
3.1 Technical competence and relevant experience to undertake
the conformity assessment activities for which they are
designated based on:
3.1.1 Technological knowledge of the relevant products,
processes or services;
3.1.2 Understanding of the technical standards and the general
risk protection requirements for which designation is
3.1.3 Experience relevant to the applicable Mandatory
3.1.4 Physical capability to perform the relevant conformity
assessment activities;
3.1.5 Adequate management of the conformity assessment
activities concerned; and
3.1.6 Any other circumstance necessary to give assurance that
the conformity assessment activities shall be adequately
performed on a consistent basis;
3.2 With legal personality in the relevant jurisdiction;
3.3 Scope of conformity assessment activities; and
3.4 Not adversely influenced by a body that manufactures or
trades in industrial products specified under Annex I,
impartial and provision of services in a manner that does
not compromise the objectivity of their conformity
assessment activities and decisions.

Section 4. Basis for Designating Testing Laboratories – The
following shall be the basis for designating a
Testing Laboratory:
4.1 Accredited to ISO/IEC 17025 (“ General requirements for the
competence of testing and calibration laboratories ” )by an
accreditation body that is a signatory to the Asia-Pacific
Laboratory Accreditation Cooperation (APLAC) Mutual
Recognition Arrangement.
4.1.1 The scope of accreditation shall cover the Mandatory
Requirements of Regulatory Authority of the other Party;
4.2 Compliant with the particular requirements set out in the
applicable laws, regulations and administrative provisions,
and with the stipulated criteria for designation as set out
in Annex IV.
4.2.1 The manufacturers ’ own testing laboratories may be
designated by one Party ’ s Designating Authority to
undertake electromagnetic compatibility tests to the other
Party ’ s Mandatory Requirements only.

Section 5. Basis for Designating Inspection Bodies – The
following shall be the basis for designating an
Inspection Body:
5.1 Accredited to ISO/IEC 17020 (“ Conformity assessment -
Requirement for the operation of various types of bodies
performing inspection ” )by an accreditation body that is a
signatory to the Asia-Pacific Laboratory Accreditation
Cooperation (APLAC) Mutual Recognition Arrangement;
5.1.1 The scope of accreditation shall cover the Mandatory
Requirements of Regulatory Authority of the other Party;
5.1.2 Compliant with the particular requirements set out in the
applicable laws, regulations and administrative
provisions, and with the stipulated criteria for
designation as set out in Annex IV.


Section 1. Required Details – When designating a Conformity
Assessment Body, the Designating Authority shall
provide the other Party with the following details in
respect of each Conformity Assessment Body it
1.1 registered name;
1.2 postal address;
1.3 facsimile (fax) number;
1.4 email address (if available);
1.5 name and telephone number of declared contact person;
1.6 scope of designation detailing range of products, reference
standards, capability and other relevant details;
1.7 designating procedure used; and
1.8 date of designation.

Section 2. Recognition Procedure – The following procedure
shall apply the recognition of a conformity
assessment body:
2.1 Each Party shall make a proposal to the other Party that a
CAB duly designated in accordance herewith be recognized
under this Arrangement, by presenting to the latter such
proposal in writing, supported by necessary documents.
2.2 The other Party shall determine whether the proposed CAB
complies with the criteria for designation set out in its
applicable laws, regulations and administrative provisions
as specified in the Annexes after which shall indicate its
position thereon within ninety (90) working days from the
receipt of the proposal referred to above. In such
consideration, such other Party should assume that the
proposed conformity assessment body complies with the
aforementioned criteria.
2.3 In the event that the other Party is unable to make a
decision on the recognition of the proposed conformity
assessment body within the prescribed period under Section
2.2 of this Article, the proposing Party may request the
other Party that a joint verification of the CAB under
consideration be conducted. After the completion of such
verification, both Parties shall make the decision regarding
the recognition of the CAB under consideration, furnishing
each other a copy of the written decision within fifteen
(15) working days from the completion of the joint

Section 3. Procedure for any Changes – The following procedure
shall apply to any changes made, viz:
3.1 Each Party shall give the other Party an advance notice of
any changes in the list of duly designated CABs, including
suspensions, at least seven (7) working days prior to said
3.2 Each Party shall inform the other Party within fifteen (15)
working days of any changes that affect a designated CAB ’
s technical competence or compliance with the relevant
Stipulated Requirements.


Section 1. Rights of the Parties – The Parties shall have the
following rights:
1.1 In exceptional circumstances, a Party retains the right to
challenge a designated CAB ’ s technical competence and
compliance with the relevant Stipulated Requirements,
provided that it is supported by relevant expert analysis
and/or evidence. The Parties may further agree on additional
guidelines for the exercise of this right.
1.2 A Party whose designated CAB is being challenged has the
right to be notified of the challenge in writing and be
provided with copies of supporting expert analysis and/or
1.3 Except in urgent circumstances, the Parties shall, prior to
a challenge, enter into consultations with a view to seeking
a mutually satisfactory solution. Consultation shall be
conducted expeditiously with a view to resolving all issues
and seeking a mutually satisfactory solution within ninety
(90) working days from commencement thereof.

In urgent circumstances, consultations shall take place
immediately after the right to challenge has been exercised.

Section 2. Suspension, Withdrawal or Revocation of Designation
– The designation of the challenged designated CAB
may be suspended, or revoked by the relevant
Designating Authority for the relevant scope of
designation from the time its technical competence or
compliance was challenged, unless the Parties decide
otherwise based on any of the following grounds:
2.1 The challenging Party is satisfied with the competence and
compliance of the Conformity Assessment Body; or
2.2 The designation of the Conformity Assessment Body has been
withdrawn prior to suspension or revocation.

Section 3. Effect of Suspension, Withdrawal or Revocation – The
results of conformity assessment activities
undertaken by a suspended, withdrawn or revoked CAB
before the date of its suspension, withdrawal or
revocation shall remain valid for acceptance for
purposes of performing a Party’s obligations under
this MRA.
3.1 The Parties shall compare methods used to verify that the
designated Conformity Assessment Bodies complied with the
Stipulated Requirements.


Section 1. Non-Disclosure – A Party shall not be required to
disclose confidential proprietary information to the
other Party except where such disclosure would be
necessary for the Party to demonstrate the competence
of its designated CAB and the latter ’ s conformity
to the relevant Stipulated Requirements.

A Party shall, in accordance with its applicable
laws, protect the confidentiality of any proprietary
information disclosed to it in connection with
conformity assessment activities and/or designation


Section 1. Preservation of Regulatory Authority – Each Party
retains all authority under its laws and implementing
rules to interpret and enforce its Mandatory

Section 2. Binding Effect of the Arrangement
2.1 Arrangements concluded by either Party with a third party
shall not impose any obligation on the other Party to accept
the results of conformity assessment undertaken in the third
party except when there is written agreement between the
Parties to do so.
2.2 This Arrangement does not require mutual acceptance of the
Mandatory Requirements of each Party, or mutual recognition
of the equivalence of such Mandatory Requirements. The
Parties shall, however, give consideration to increasing the
degree of harmonization or equivalence of their respective
Mandatory Requirements. Where both Parties agree that the
standards or technical regulations are harmonized or
established as equivalent, a Party shall be able to assess
compliance with its own Mandatory Requirements and this
shall be deemed acceptable by the other Party.
2.3 The Mandatory Requirements to which this Arrangement applies
shall be third party conformity assessment activities except
product certification for the product referred to in Section
3.1 of Article I of this Arrangement. The applicable laws,
regulations and administrative provisions are set out in
Annex III.

Section 3. Amendments/Revisions to this Arrangement – Any
amendments and/or revisions to this Arrangement shall
be mutually agreed upon by the Parties in writing.

Section 4. Amendments/Revisions to Mandatory Requirements –
Where a Party changes its Mandatory Requirements for
products covered by this Arrangement, its obligations
under Article II hereof as applicable, shall extend
to accepting the results of conformity assessment
activities in relation to the changed Mandatory
Requirements if these fall within the scope of
activities for which relevant Conformity Assessment
Bodies have been designated in accordance with this

Section 5. Effectivity and Duration of the MRA – This
Arrangement shall take effect upon signing, which
shall be valid for a period of five (5) years and
shall be automatically renewed for another five (5)
years unless either Party proposes to re-negotiate
not earlier than six (6) months before its

Section 6. Termination of MRA – Either Party may terminate this
Arrangement within the validity of the Arrangement by
giving the other Party six months ’ advance notice
in writing.

Following termination of this Arrangement, a Party
shall cease to accept the results of conformity
assessment activities performed by designated
Conformity Assessment Bodies.

Section 7. Contact Points – The contact points for the
respective Regulatory Authorities shall be as
7.1 For the Philippines: The Bureau of Philippine Standards of
the Department of Trade and Industry;
7.2 For Taiwan: The Bureau of Standards, Metrology and
Inspection of the Ministry of Economic Affairs.

Done in duplicate in the Chinese and English languages, both
texts having equal validity. In case of divergence in
interpretation of this Arrangement, the English text will

The Taipei Economic The Manila Economic
and Cultural Office in and Cultural Office
the Philippines
__________________ __________________
Song-Huann Lin Angelito Tan Banayo
Representative Representative

Date: 7 December 2017 Date: 7 December 2017
Place: Manila Place: Manila

Witnessed by:

Bureau of Standards, Bureau of Philippine
Metrology and Standards, Department
Inspection, Ministry of of Trade and Industry
Economic Affairs

__________________ __________________
Dr. Ming-Jong Liou Ernesto V. Perez
Director General Assistant Secretary
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