Public Federal Service

MINISTRY OF DEVELOPMENT, INDUSTRY AND EXTERNAL TRADE

NATIONAL INSTITUTE OF METROLOGY, STANDARDIZATION AND INDUSTRIAL QUALITY -CONMETRO

Resolution No. 05, of May 6, 2008.

Decides on the approval of the Regulation for Object

Registration with Compulsory Assessed Compliance,
through a program coordinated by the National Institute
of Metrology, Standardization and Industrial Quality -
Inmetro

THE NATIONAL COUNCIL OF METROLOGY, AND INDUSTRIAL QUALITY - Conmetro,

invested in its powers, as to article 3 of Law No. 5966 of December 11, 1973, and Article 2 of Law No.
9333 of December 20, 1999;
Considering the provisions of paragraphs “a” and “e” of article 3 and article 5 of Law 5966 of December
11, 1973;
Considering the provisions of section IV of article 3 of Law 9933/99 of December 20, 1999;
Considering the provisions of Conmetro Resolution No. 01 of September 06, 2007;
Considering the need to widely publicize to the sectors affected by the registration implementation;
Considering Inmetro’s need to adequate its infrastructure to perform object registration;
Considering the need to improve the market monitoring of products, processes, services and persons with
assessed compliance under the scope of the Brazilian System of Compliance Assessment.

DECIDES:
Article 1. To approve the Regulation for Object Registration with Compulsory Compliance Assessment,
through the attached Inmetro’s Coordinated Program.
Article 2. The registration of objects with assessed compliance will become active within 20 (twenty)
months from the date of its publication.
Sole Paragraph: The implementation of the Regulation, herein approved, shall comply with the provisions
of Article 37 of the mentioned attached document.

MIGUEL JORGE

State Minister for Development, Industry and Foreign Trade

Conmetro’s President
 REGULATION FOR OBJECT REGISTRATION WITH COMPLIANCE ASSESSMENT
PERFORMED ACCORDING TO AN INMETRO COORDINATED PROGRAM.

TITLE I
General Provisions

Chapter I
Objective
Article 1. This Regulation lays down the general rules and procedures relative to registration, at Inmetro, of
compulsorily compliance assessed objects, based on regulations issued by Inmetro as regulatory entity or as a result
of delegated competence.

Sole Paragraph: The object with assessed compliance, subject to model approval by Inmetro will be exempt from
registration.

Article 2. The registration shall be granted to:

I - authorize and monitor the use of Inmetro’s compliance identification stamp;
II - authorize the marketing of objects in the country, as a mandatory measure;
III - detail the supplier’s responsibility;
IV - facilitate and implement quicker market monitoring actions on the object;
V - provide effectiveness of the exercise of administrative police power as to the State control over objects with
assessed compliance.

Chapter II
Definitions and Acronyms

Article 3. For the purposes of this Regulation the following definitions shall apply:
I. Market monitoring
A system to determine whether the products reaching the market do still preserve the requirements met by the
supplier. At Inmetro, the Compliance Assessment Programs under the scope of the SBAC are subject to three
monitoring actions on the market: Inspection, conducted by RBMLQ-Inmetro; Compliance Verification conducted
by the Quality Board of this Institute; and Market Monitoring conducted by external agents. (Source: Booklet on
Compliance Assessment, Quality Management Board, May 2007, 5th edition).
II. Compliance Assessment
Systematic process, with pre-established rules, duly monitored and evaluated, in order to provide adequate degree
of confidence that a product, process or service, or a professional, meet the requirements established by the
predetermined normative basis, with the lowest cost possible for the society. (Source: Booklet on Compliance
Assessment, Quality Management Board, May 2007, 5th edition).
III. Accreditation (Compliance Certificate)
Issuance of a statement, based on a decision made after the critical analysis, that compliance to specified
requirements has been demonstrated. (Source: ABNT NBR ISO / IEC 17000:2005)
IV. Activity of Compliance Assessment by First Party
Compliance assessment activity performed by a person or organization that supplies the object. (Source: ABNT
NBR ISO / IEC 17000:2005)
V. Activity of Compliance Assessment by Third Party
Compliance assessment activity performed by a person or organization independent from the person or organization
that supplies the object and from the user’s interest in that object. (Source: ABNT NBR ISO / IEC 17000:2005)
VI. Documents of the compliance assessment program
Any documents relative to a compliance assessment program for a given object, approved by Inmetro Ordinance.
VII. Test
Determination of one or more characteristics of an object subject to compliance assessment, according to a
procedure. (Source: ABNT NBR ISO / IEC 17000:2005)
VIII. Family
Group of objects with the same characteristics, as defined and/or classified in the documents of the compliance
assessment programs.
IX. Supplier
All person or entity, public or private, national or foreign, and also unincorporated entities, performing activities of
production, assembly, creation, construction, processing, import, export, distribution or marketing of products or
services. (Source: Code of Consumer Protection)
X. National Institute of Metrology, Standardization and Industrial Quality - Inmetro
Federal agency created by Law No. 5966/73 as the executive body of the National System of Metrology
Standardization and Industrial Quality - Sinmetro, holding powers defined by Law No. 9933/99.
XI. Object or object with assessed compliance
Definition used in this regulation to cover any product, service, facility, process, system or person to which
compliance assessment is applied. A service is covered by the definition of a product. (Source: ABNT NBR ISO /
IEC 17000:2005)
XII. Delegate Entity
National, federal, state or city public institution, member of the Brazilian Network for Legal Metrology and Quality
- Inmetro - RBMLQ-I, contracted by Inmetro.
XIII. Compliance Assessment Entity
Organizations that provide the following services of compliance assessment: certification of management system,
product certification, personnel certification, testing, calibration and inspection.
XIV. Compliance Assessment Program - PAC
Program prepared to evaluate the compliance of an object in a systemic and formally attested way, having a larger
reference basis, for certifying the compliance of the assessed object. It consists on the Regulation on Compliance
Assessment - RAC and the Technical Standard or the Quality Technical Regulation - RTQ. If there is no technical
standard appropriate to the needs of the program only the RTQ can be used. (Source: NIT-DIPAC-012, version 02)
XV. Compliance Verification Program - PVC
Preventive action performed by Inmetro or legally recognized external agents, whose aim is to verify the
maintenance, when reaching the market, of the object’s compliance to specified requirements, in order to prove the
effectiveness of the Compliance Assessment Program and identify opportunities for improving it.
XVI. Registration
The procedure through which Inmetro, in the way and in cases provided for in this Regulation, authorizes, subject
to the existence of the Compliance Certificate, the use of the compliance identification stamp and, mandatorily
authorizes the marketing of the object.
XVII. Compliance Assessment Regulation - RA C
Document containing specific rules and establishing systemic handling procedures for the compliance assessment
of products, processes, services, persons or quality management systems in order to provide adequate degree of
confidence in relation to the standard requirements or the technical regulation. (Source: NIT-DIPAC-012, version
02)
XVIII. Quality Technical Regulation - RTQ
Document defining the technical requirements the product, process, service, person or management system must
meet. (Source: NIT-DIPAC-012, version 02)

TITLE II
Registration Procedures

Chapter I
General Conditions

Article 4. The supplier of the object is considered the only legitimate party to request the object registration to
Inmetro, as the applicant.
Paragraph 1. A national supplier must be legally constituted under Brazilian law.
Paragraph 2. A foreign supplier must have a legal representative, legally established in Brazil, able to assume the
responsibilities arising from the compliance assessment and marketing of the object and providing user support in
the country.

Article 5. Inmetro shall make available on its website, www.inmetro.gov.br the list of objects subject to registration
and the following information:
I - for those objects subject to compliance assessment by third parties:
a - the documents of the compliance assessment program, concerning the object, and
b - a list of accredited entities to issue the Compliance Certificate.
II - for those objects subject to compliance assessment by first party:
a - the documents of the compliance assessment program, concerning the object, and
b - a list of accredited laboratories to issue the test report and/or a delegate entity to perform the analysis of the
documentation and/or monitoring verification.

Article 6. Each registration concurrently corresponds to:

I - a brand/model or family;
II - a supplier; and
III - a plant or an installation place.
Paragraph 1. The identification of the brand/model or family, the classification of families or other type of
distinction for the object included in the Compliance Certificate, must meet the criteria established in the
documents of the compliance assessment program.
Paragraph 2. The brand and model of the product must be in accordance to the terminologies established by the
manufacturer.

Article 7. The registration cannot be transferred or assigned to third parties except in the case of continued use by
succession recognized by Inmetro.

Article 8. The payment of the value for the object's registration must be done using the official document “Guia de
Recolhimento da União - GRU” (Payment Certificate)

Sole Paragraph: Payment can be made in cash or by check, and, in case of payment by check, the request for
registration will be automatically canceled if the check is returned due to insufficient funds.
Article 9. In irregularities happen, mentioned in Articles 21 and 24 of this Regulation, relative to an object included
in a family, the penalty of suspension or cancellation of the family should be applied.

Article 10. The registration authorizes the use of the compliance identifying stamp and is a mandatory pre-requisite
for the marketing of objects in the country.

Chapter II
Granting the Registration

Article 11.The certification of compliance of an object as to the documents of the compliance assessment program,
is an essential step for the granting of registration to that object.

Article 12. For the Inmetro registration, the applicant shall submit the following documents:
I - Compliance Certificate, subject to the provisions of this regulation, as evidence of the object’s compliance;
II - Evidence of payment of the legally establish amount for the object's registration, using the official document
“Guia de Recolhimento da União - GRU” (Payment Certificate);
III - Constitution of the supplier’s company and legal documents proving that the applicant is legally empowered to
represent it;
IV - Commitment statement as to the compliance assessment signed by the supplier’s legal representative.
V - Request form.
IV - Additional documents for granting an object registration, required in the documents of the compliance
assessment program, whether or not they are described in this article.

Article 13. The presentation of the documents listed in the preceding article is the responsibility of the applicant
and must occur by any physical or electronic means.

Article 14. Upon fulfillment of the requirements for granting the registration, Inmetro must grant it within 15
(fifteen) calendar days and will announce it on its website and in the Official Gazette of the Union - DOU.
Paragraph 1. The publication in the Gazette will occur weekly and shall contain the numbers of registrations
granted and the identification of their respective owners.
Paragraph 2. The relevant information for the registration shall be made available at the Inmetro’s website.
Paragraph 3. The registration is valid from the date it was granted.

Article 15. Inmetro should reject the registration if:

I - there is evidence on the existence of formal flaw in the Compliance Certificate;
II - the Compliance Certificate is issued by a non-accredited entity or one whose accreditation has been suspended
or terminated;
III - the Compliance Certificate is issued based on regulations different from those applicable to the subject and in
force in the country;
IV - some documents required by this Regulation are not included; or
V - Inmetro detects any other irregularity.
 TITLE III
Validity and Registration Identification

Chapter I
Validity of Registration

Article 16. The Registration is valid for the same period of the Compliance Certificate issued for the registered
object.
Paragraph 1 - The terms and criteria for granting, maintaining and renewing the Compliance Certificate are defined
in the documents of the compliance assessment program for each object.
Paragraph 2 - The registration holder is responsible for maintaining and renewing the compliance certification of
the object concerning registration validity.
Paragraph 3 - In the cases of products which compliance was assessed by a batch model, the registration
exclusively belongs to the assessed batch.
I - Any object included in the compliance certificate issued for certification by the batch model, must be registered.

Article 17. The registration holder must inform Inmetro about changes to its registration data, through an additional
memorandum, published in the Official Gazette of the Union, in order to update the record.

Article 18. Any changes to the design or process of the registered object, modifying the technical characteristics
that were the basis for obtaining the compliance certificate, shall give origin to a new registration.

Chapter II
Registration Identification

Article 19. The registered object must bear the Inmetro’s compliance identification stamp, including the
registration identification, legibly and indelibly, according to the model and instructions set forth in the documents
of the compliance assessment program.
Sole Paragraph: The program documents will address those cases of objects that, due to their specificities, cannot
respect the conditions of the caput of this article.

Article 20. The constitution of the alpha-numeric code of the registration must follow the rules laid out by an
Ordinance from Inmetro.

Chapter III
Suspension and Cancelation of the Registration

Section I Suspension of Registration

Article 21. The registration can be suspended in the event of:

I - failure to change the object requirements, accurately and timely, upon determination of adjustment to new
regulations published by Inmetro;
II - the suspension of the validity of the Compliance Certificate by the accredited body;
III - any irregularity detected by Inmetro as to the registration procedure;
IV - possibility of damage, caused by the object, to the health and safety of the user and the environment;
V - non-compliance as to the requirements of the documents of the compliance assessment program relative to
each object.
VI - finding relevant and unjustified discrepancies between the results of tests conducted on samples of the assessed
object and those from further assessment or monitoring actions in the market;
Sole paragraph: the suspension of the registration does not preclude the application of appropriate penalties provided
for in any legal and regulatory document.

Article 22. The holder of the registration shall be notified of the suspension.
Paragraph 1. The suspension must be justified, and shall state the measures to be taken by the notified entity,
specifically including the suspension period, which shall be up to 180 (one hundred and eighty) days.
Paragraph 2. Inmetro will decide as to the acceptance or rejection of the measures taken.
Paragraph 3. The suspension will last for as long as Inmetro refuses to accept the measures taken and until the term
referred in paragraph 1.
Paragraph 4. In case of rejection of the measures taken, Inmetro can decide to continue the suspension or to cancel the
registration.

Article 23. The suspension of the validity of the Registration does not stop or suspend the flow of the validity period of
the Compliance Certificate.

Section II
Cancelation of the Registration

Article 24. The registration will be cancelled in case of:

I - any fraud, false statements or false documentary evidence submitted during the Registration procedure;
II - marketing of the object within the period when the registration’s validity is suspended or practice of any act in
breach of the declaration of suspension of the Registration;
III - request from the Registration’s applicant;
IV - repeated practice of the acts referred to in article 21 of this regulation; or
V - failure to fully and timely comply with the provisions made in the suspension act, referred to in paragraph 1 of
article 22 of this regulation.
Sole Paragraph: The cancelation of the registration does not preclude the application of appropriate penalties provided
for in any legal and regulatory document.

Article 25. Inmetro may determine the cancelation of the objects registration, at any time and if a risk is detected as to
the health and safety of users or the environment.
Sole Paragraph - If a possibility of damage to health and safety of the user and the environment arises, Inmetro shall
widely publicize the fact, warning the public about the risks of continued use of that object.

Article 26. Inmetro will always keep an updated and complete list of suspended or canceled registrations, available to
the public.
Sole Paragraph - Regardless of what is determined above, the act of cancellation of the registration will receive the
same publicity given to acts of granting a registration.

Chapter IV
Renewal of the Registration

Article 27. The registration holder may request its renewal to Inmetro, adding to such request the proof of payment
using the “Guia de Recolhimento da União - GRU” (Payment Document) regarding the corresponding renewal
according to the legal dispositions in force, and previously subjecting the object to the necessary procedures for
issuing the Compliance Certificate.
Paragraph 1. The renewal of the registration shall be requested up to 45 (forty-five) days before the expiration date of
the Compliance Certificate.
Paragraph 2. After the period set forth in the previous paragraph, the holder of the registration must request a new one.
Paragraph 3. In case of registered products which compliance was assessed by a batch model, there will be no
registration renewal.

TITLE IV
Penalties

Article 28. The penalties offenders will be subject to, besides those provided for in this regulation, are the ones defined
in Article 8 of Law 9933/99.

TITLE V
Final Provisions

Article 29. The Registration will not prevent the misuse of the object.

Article 30. The Registration will not exempt the supplier of the registered object in the country, from the
responsibilities inherent to the marketing of that object.

Article 31. The amounts paid for the registration will not be returned.

Article 32. Inmetro may, at any time, including in cases of suspension and cancelation of the registration, withdraw
from the market the registered products, whenever there is a risk for the health and safety of users or the environment.

Article 33. Inmetro shall publicize the non-confidential information concerning the Registration procedures, keeping a
public record containing:
I - the whole contents of the active compliance assessment program;
II - the list of registered objects, including information on objects and suppliers;
III - the list of accredited entities;
IV - the list of accredited laboratories; and
V - the decisions on penalties, especially those relative to public safety, health, environment and local economy.

Article 34. Forms, instructions and additional provisions will be published by Inmetro.

Article 35. Inmetro must monitor and keep registration processes, to ensure its implementation will happen within the
conditions established herein.

Article 36. In case of suspension or cancellation of the registration, upon receipt of notification of such decision, the
entity responsible for the object will be bound to immediately stop using Inmetro’s compliance identification stamp, as
well as any publicity made to the fact and will compulsorily stop the marketing of the object.
 TITLE VI

Transitional Provisions

Article 37. This regulation is applicable to compliance assessment programs initiated or reviewed after its entry
into force, except in cases where Inmetro is not the regulating entity and the authority to make registrations has not
been delegated.

Sole paragraph - The Compliance Assessment programs issued before the entry into force of the present regulation
shall be adjusted to it upon revision.