REGULATORY ASPECTS ON
CONFORMITY ASSESSMENT AND
HOMOLOGATION FOR
TELECOMMUNICATION PRODUCTS
ANATEL - BRAZIL
Julio Cesar Fonseca
Technical Regulations Manager
ITU Consultation on conformance Assessment and
Interoperability Testing – Quito - Ecuador, 6 July 2010
Quito, 6 July 2010
International
Telecommunication
Union
1
ANATEL AS A DESIGNATING
AUTHORITY
ACCORDING TO THE CERTIFICATION
AND APPROVAL REGULATION
RES. Nr. 242
Quito, 6 July 2010
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Telecommunication
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OBJECTIVE & GENERAL PRINCIPLES
The evaluation of the conformity of the telecom
products in connection with the technical
regulations issued or adopted by Anatel;
The requirements for approval of telecom products
in the Regulation approved by the Resolution 242.
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THE PURPOSE OF THE REGULATION
- The purpose is to establish the general rules and
procedures relating to certification and approval of
telecom products;
- The Regulation also establishes the main rights and
obligations for manufactures , services providers,
suppliers and users, considering the penalties involved
- In addition, the regulation considers several
requirements to comply with the Mutual Recognition
Agreement - MRA.
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THE PRINCIPLES
I - to ensure that the products sold or used in the
Country are in conformity with the regulations issued
or to the standards adopted by ANATEL;
II - to ensure that the suppliers of the products meet
the minimum quality requirements for their products;
III - to ensure that the telecommunications products
marketed in the Country, in particular those offered
by the business directly to the public, have a
minimum standard of quality and are suitable for the
services for which they are intended; and…
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IV - to ensure that the products meet with the
requirements of safety and the environment;
V - to facilitate the entry of Brazil into international
agreements of mutual recognition;
VI - to promote uniformity in the treatment given to
the interested parties in the certification and the
approval of telecommunication products; and
VII - to treat as confidential technical information,
which is thus required, from the information made
available by the interested parties by the force of
this Regulation.
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The
mandatory
requirements
for
certification, and approval are applied for all
products classified under the following
definitions:
Category I : final user terminal equipment
(wired, and wireless);
Category II: radio frequency equipment;
Category III: network equipment;
Note: The products have to comply with the requirements
for EMC and Safety.
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APPLICABLE REGULATIONS AND
STANDARDS FOR CERTIFICATION
Anatel is authorized to issue regulations and
standards for certification, to be observed in the
certification and approval processes provided in this
regulation.
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APPLICABLE REGULATIONS AND
STANDARDS FOR CERTIFICATION
In the absence of regulations or standards for
certification issued by Anatel, the Agency will
be responsible for deliberating on the
appropriateness and the viability of the
certification and approval;
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APPLICABLE REGULATIONS AND
STANDARDS FOR CERTIFICATION
Anatel may, at its discretion, require field tests to
be undertaken on the product or equipment, so as
to obtain support for its final decision with regard to
the appropriateness or with regard to the viability of
the certification.
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CERTIFICATION AND APPROVAL
PROCEDURES
As described in the Single Paragraph of the Art. 21,
the issue of the approval document is an
obligatory pre-requisite for the purposes of
marketing and use, in the country, of products
classified in Categories I, II and III.
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THE STRUCTURE OF THE PROCESSES OF
CERTIFICATION AND APPROVAL
The following agents will act in the processes of
certification and of approval of
telecommunications products, categories I, II and
III:
I - Administration of Radio frequencies and Control;
II - Appointed Certification Bodies; and
III - Test Laboratories.
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Certification Bodies
non profit organizations established in Brazil, with
the technical and administrative capacity to carry
out correctly the conformity evaluation process of
telecommunications products. The requirements are
defined in the Annex 1 of the Resolution 242; or
foreign certification bodies recognized through
Mutual Recognition Agreement.
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Certification Bodies
Certification bodies, must meet one of the following
requirements:
appointed by Anatel;
organizations accredited by Inmetro to certify
telecommunications products
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Test Laboratories
1. The conformity test reports will be conducted
by
laboratories
accredited
by
INMETRO
or
evaluated by a CAB.
2. Future convergence from Anatel´s certification
system to the National Certification System
(INMETRO will accredit the test laboratories).
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Mutual Recognition Agreements - ARM
Anatel will be able to sign Mutual Recognition
Agreements - ARM, in matters of evaluation of
the conformity of telecommunications products, the
purpose of which is the recognition of certification
bodies and of test laboratories, as integral parts of
the system for conformity evaluation adopted by it.
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CERTIFICATION REQUIREMENTS
I - Declaration of Conformity;
II - Declaration of Conformity with test report;
III - Certificate of Conformity based on standard
test;
IV - Certificate of Conformity based on standard test
and on periodic evaluations of the product; or
V - Certificate of Conformity with evaluation of the
quality system.
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The Declaration of Conformity
must:
1. indicate the regulations or standards
applicable to the product;
2. confirm that the product complies with the
applicable regulations and standards;
* Applicable to the products skilled produced for
own use.
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Declaration of Conformity with
Test Report
A. The Declaration of Conformity must be
accompanied by the test reports produced by the
laboratories.
B. Tests carried out preferably by a third party
laboratory;
* Applicable in the excepcional hypotesis when
Anatel will advance to conduct the conformity
evaluation process.
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Certification of Conformity Based on
standard test
A. The certificate of conformity based on standard
test must be issued by the appointed CAB;
B. CAB must carry out the certification in accordance
with the standards issued or adopted by Anatel;
C. Certification issued for CATEGORY III products
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Certificate of Conformity based on
periodic standard tests
A. The certificate of Conformity for products subject to
periodic tests will confirm the conformity of the
product with the applicable regulations.
B. Certification issued for CATEGORY II products.
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Certificate of Conformity with periodic
tests and quality system evaluation
A. The Certificate of Conformity with periodic tests
and evaluation of the quality system will be issued,
by an CAB, and will confirm the conformity of the
product with the applicable regulations.
B. CAB must guarantee that the manufacturer’s
quality system covers the necessary procedures in
accordance with the standards for certification.
C. Certification issued for CATEGORY I products.
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Test Reports
The use of laboratories must observe the
following order of priority:
1. accredited laboratories;
2. third party, second party, first party
laboratories, non-accredited, evaluated by a
CAB;
3. non-accredited third party, second party,
first party laboratories;
4. test laboratories situated abroad
accredited by the official Accrediting
Organization - ILAC.
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APPROVAL REQUIREMENTS
An application for certification and approval in
Brazil can be submitted by one of the following:
I - the manufacturer of the product;
II - the supplier of the product in Brazil; and
III - a natural person or a legal entity that asks for
the approval of the telecommunications product for
its own use.
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APPROVAL REQUIREMENTS
The requirements are described as follows:
the certificate of conformity of the product;
proof of payment;
user’s manual written in Portuguese language
(when the product is intended for direct sale );
and,
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APPROVAL REQUIREMENTS
legal documentation about the interested party;
proof that the interested party is legally established
according to Brazilian laws, or has commercial
representation in Brazil, such that it will be
responsible for the quality, supply and technical
assistance relating to the product in the national
territory.
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VALIDITY AND IDENTIFICATION OF
APPROVAL
I - undetermined for the products approved by
Certificate of Conformity;
II - two years for products approved by Declaration
of Conformity, with test report;
III - five years for products approved by
Declaration of Conformity, applicable to the
products of skilled manufacture for own use.
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REQUIREMENTS FOR THE LABLE
ANATEL mark, ID, Bar code
HHHH-AA-FFFF
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SUSPENSION AND CANCELLATION
OF THE APPROVAL
By the Certification body when:
I - the interested party does not carry out the
adaptations by alteration of the regulation;
II - the interested party does not address the
clauses of the accompanying contract for periodic
evaluation of the product or for the maintenance of
the manufacturer’s Quality System; and,
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SUSPENSION AND CANCELLATION
OF THE APPROVAL
III - the interested party makes use of the
Certificate of Conformity to advertise characteristics
of the product which have not been subject to
evaluation; or
IV - the interested party makes use of any
advertising of the certification of products that
leads third parties to have certified a different
product from the one that is effectively certified.
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SUSPENSION AND CANCELLATION
OF THE APPROVAL
By Anatel when:
I - the true and opportune non-alteration to the
specifications of the product, in view of the decision
of adaptation to the new regulations issued by
Anatel;
II - the use or the marketing of a product with
alterations without compliance with the obligations
about modifications in the project or in the
manufacturing process;
and,
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SUSPENSION AND CANCELLATION
OF THE APPROVAL
III - the suspension of the validity of Certificate of
Conformity by the Appointed Certification body; and
IV - any irregularity in the certification and approval
processes noted by Anatel.
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SANCTIONS
-
-
warning;
fine: from U$ 50.00 to 1,500,000.00;
suspension of the approval;
cancellation of the approval;
suspension of the appointment;
cancellation of the appointment.
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THE APPROVAL OF THE
CERTIFICATE
Anatel will issue an approval document for every
product that holds a certificate issued by the
national CAB’s
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Benefits for the Brazilian Society
1.
2.
3.
4.
5.
Provide adequate way to identify the products,
and to facilitate the enforcement;
Building the confidence in the Anatel’s mark;
To provide a good privilege to the maker, and to
the trade legally established in Brazil;
To guarantee the conformity of the products;
To avoid damage for the network, and prejudice
to the user.
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Thank you
Julioc@anatel.gov.br
+55-61-2312421
Geneva, 20-21 July 2009
International
Telecommunication
Union