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WTO notification · TBT

BrazilCorrected since it was notified

Orthopaedic appliances – Brazil

Official title

Ministerial Act nº 80, 15th February 2012 (13 pages, in Portuguese).

Brazil issued a correction on 17 September 2026 to the earlier TBT notification G/TBT/N/BRA/475. The measure was first notified on 6 March 2012. The comment period closed on 18 October 2025.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

Updated here:

At a glance

Products

Breast Implants

HS codes
  • 90 · Optical, photographic, cinematographic, measuring, checking, medical or surgical instruments and apparatus; parts and accessories
    • 902139 Artificial parts of the body (excl. artificial teeth and dental fittings and artificial joints)
Notifying member
Brazil
Status
Corrected since it was notified
Objectives
  • Protection of human health or safety
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/BRA/475Latest notice: G/TBT/N/BRA/475/Add.4/Corr.1
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 18 October 2025
Proposed adoption
Upon publication in the Official Journal after received comments have been taken into account.
Proposed entry into force
To be determined in the final text.

How to comment

The comment period closed on 18 October 2025. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/BRA/475/Add.4/Corr.1; it can take them up with Brazil.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

The Act establishes criteria for the program of conformity assessment for Breast Implants, under the regime of Health Surveillance, by the compulsory certification mechanism.

Notices on this measure

Every notice about this measure published here, newest first. Each one is the notifying member's own text.

  1. CorrigendumG/TBT/N/BRA/475/Add.4/Corr.1

    Ordinance No. 209 30 March 2022

    Rectification of Inmetro Ordinance No. 209 30 March 2022, published in the Federal Official Gazette on 5 May 2026, Section 1, page 36, in Article 1, regarding Annex I of Inmetro Ordinance No. 5 of 11 January 2022.

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

  2. AddendumG/TBT/N/BRA/475/Add.4

    Amendment of Inmetro Ordinance No. 5, 11 January 2022

    National Institute of Metrology, Quality and Technology - Inmetro amends Ordinance No. 5, 11 January 2022, which approves the Conformity Assessment Requirements for Breast Implants - Consolidated.

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

  3. AddendumG/TBT/N/BRA/475/Add.3

    Comment deadline: Closed on 18 October 2025

    Public Consultation No. 24, 19 August 2025

    National Institute of Metrology, Quality and Technology - Inmetro amends Ordinance No. 5, 11 January 2022 that consolidates the conformity assessment requirements for Breast Implants. Criticisms and suggestions should be presented on the Participa + Brasil Platform:

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

  4. CorrigendumG/TBT/N/BRA/475/Add.2/Corr.1

    The rectification text is available only in Portuguese and can be downloaded at:

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)Notified document (opens in a new tab)

  5. AddendumG/TBT/N/BRA/475/Add.2

    Consolidation of conformity assessment requirements for Breast Implants.

    National Institute of Metrology, Quality and Technology - Inmetro issued Ordinance No. 5, 11 January 2022 that consolidates the conformity assessment requirements for Breast Implants. The aim of the consolidation of the regulation is to attend decree no. 10.139 of 28 November 2020. Inmetro Ordinance no. 5 revokes the following acts on the effective date of adoption: Inmetro Ordinance No. 162, of 5 April 2012, published in the Brazilian Official Gazette of 9 April 2012, section 1, page 113; and; Inmetro Ordinance No. 323, of 25 June 2012, published in the Brazilian Official Gazette of 27 June 2012, section 1, page 55, previously notified through G/TBT/N/BRA/475/Add.1

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)Notified document 1 (opens in a new tab)Notified document 2 (opens in a new tab)

  6. AddendumG/TBT/N/BRA/475/Add.1

    This addendum aims at informing that the National Institute of Metrology, Quality and Technology/INMETRO issued the Ministerial Act nº 323/2012 which modifies the Ministerial Act nº 162/2012 and Ministerial Act nº 80 notified under G/TBT/N/BRA/475 which defined the conformity assessment procedure for breast implants.; The full text of this measure is available in Portuguese and can be downloaded at:;

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

  7. Regular notificationG/TBT/N/BRA/475

    Comment deadline: Closed on 18 March 2012

    Ministerial Act nº 80, 15th February 2012 (13 pages, in Portuguese).

    The Act establishes criteria for the program of conformity assessment for Breast Implants, under the regime of Health Surveillance, by the compulsory certification mechanism.

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

All updates from Brazil

  1. WTO notificationTBTAdopted, according to its latest notice

    Ordinance Nº. 487, 04 November 2014. The text proposes to rewrite and, include some items of the document previously notified as G/TBT/N/BRA/461/Add.1 in order to upgrade and…

    The revised text proposes to include three (3) different certification models (items 6.1); to include item 6.4 as certification model 3; and to rewrite clauses 6.2.1 and 6.2.2, to provide terms and conditions to assess and maintain conformity. Other provisions contained in the Inmetro Ordinance Nº…

    Symbol: G/TBT/N/BRA/461/Rev.1/Add.7Comment period closed

  2. WTO notificationSPSProposed measure, open for comments

    Draft. Establishes the phytosanitary requirements for the importation of seeds of Canna spp. produced in the Kingdom of Thailand

    Draft Ordinance aiming to establish the phytosanitary requirements for the import of seeds (Category 4) of Canna spp. produced in Thailand. The consignments must be accompanied by a Phytosanitary Certificate, issued by the National Plant Protection Organization – NPPO of Thailand, as detailed on…

    Symbol: G/SPS/N/BRA/2548Comments until 8 January 2027

  3. WTO notificationSPSProposed measure, open for comments

    Draft Resolution 1430, 14 October 2026

    This draft resolution proposes amendments to the agronomic class (item 2.1) and to the wording of items 2.3 and 3.1 of Monograph P74 - Priestia megaterium, in the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by…

    No products listed by the notifying member

    Symbol: G/SPS/N/BRA/2547Comments until 8 January 2027

  4. WTO notificationSPSProposed measure, open for comments

    Draft Resolution 1428, 7 October 2026

    This draft resolution proposes the inclusion of the active ingredient T86 - Trichoderma Yunnanense in the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservatives, which was published by Normative Instruction 103 on 19 October 2021 in the Brazilian…

    No products listed by the notifying member

    Symbol: G/SPS/N/BRA/2546Comments until 8 January 2027

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