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Quito, 6 July 2010 International Telecommunication Union 1 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

International Telecommunication Union Quito, 6 July 2010 1 REGULATORY ASPECTS ON CONFORMITY ASSESSMENT AND HOMOLOGATION FOR TELECOMMUNICATION PRODUCTS

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Page 1: International Telecommunication Union Quito, 6 July 2010 1 REGULATORY ASPECTS ON CONFORMITY ASSESSMENT AND HOMOLOGATION FOR TELECOMMUNICATION PRODUCTS

Quito, 6 July 2010InternationalTelecommunicationUnion 1

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

Page 2: International Telecommunication Union Quito, 6 July 2010 1 REGULATORY ASPECTS ON CONFORMITY ASSESSMENT AND HOMOLOGATION FOR TELECOMMUNICATION PRODUCTS

Quito, 6 July 2010InternationalTelecommunicationUnion 2

ANATEL AS A DESIGNATING

AUTHORITY

ACCORDING TO THE CERTIFICATION

AND APPROVAL REGULATION

RES. Nr. 242

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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 PRINCIPLESI - 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; orforeign 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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Quito, 6 July 2010InternationalTelecommunicationUnion 16

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.

Mutual Recognition Agreements - ARM

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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; orV - 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; andIII - 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; orIV - 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. Provide adequate way to identify the products, and to facilitate the enforcement;

2. Building the confidence in the Anatel’s mark;

3. To provide a good privilege to the maker, and to the trade legally established in Brazil;

4. To guarantee the conformity of the products;5. To avoid damage for the network, and prejudice to

the user.

Page 36: International Telecommunication Union Quito, 6 July 2010 1 REGULATORY ASPECTS ON CONFORMITY ASSESSMENT AND HOMOLOGATION FOR TELECOMMUNICATION PRODUCTS

Geneva, 20-21 July 2009

InternationalTelecommunicationUnion

Thank you

[email protected]+55-61-2312421