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Description of content
Comment deadline
BRAZIL
G/TBT/N/BRA/1262
Resolution 543, 30 August 2021. Language: Portuguese. Number of Pages: 1. This resolution extends the application of notification of medical devices to textile yarns with thermal properties, indicated for the composition of garments with therapeutic, beautifying or aesthetic correction effects.
Not Applicable
BRAZIL
G/TBT/N/BRA/1261
Resolution 545, 30 August 2021. Language: Portuguese. Number of Pages: 3. G/TBT/N/BRA/1261 This resolution disposes about electronic protocol for issuing a Product Certificate (Certificate of Notification or Registration of Medical Device) and Certificate for Foreign Government (Certificate of Notification or Registration for Export of Medical Device).
Not Applicable
BRAZIL
G/TBT/N/BRA/1260
Resolution 542, 30 August 2021. Language: Portuguese. Number of Pages: 1. This resolution defines "group of products" to which item 5.3 of Annex II of Law 9.782, 26 January 1999, applies.
Not Applicable
BRAZIL
G/TBT/N/BRA/1259
Resolution 546, 30 August 2021. Language: Portuguese. Number of Pages: 6. This resolution disposes about essential safety and efficacy requirements applicable to medical devices.
Not Applicable
BRAZIL
G/TBT/N/BRA/1258
Resolution 548, 30 August 2021. Language: Portuguese. Number of Pages: 6. This resolution disposes about the performance of clinical trials with medical devices in Brazil.
Not Applicable
BRAZIL
G/TBT/N/BRA/1257
Resolution 551, 30 August 2021. Language: Portuguese. Number of Pages: 3. This resolution disposes for the mandatory execution and notification of field actions by the holders of medical devices market authorization in Brazil.
Not Applicable
BRAZIL
G/TBT/N/BRA/1245
Resolution 556, 30 August 2021. This resolution disposes about requirements for the grouping of medical devices for market authorization and notification purposes in the Brazilian Health Regulatory Agency (Anvisa) and adopts traceability labels for implantable products.
Not Applicable
BRAZIL
G/TBT/N/BRA/1244
Resolution 555, 30 August 2021. This resolution disposes about the framing of "Limulus Amebocyte Lysate (LAL) Reagent" in the Technical Regulation on medical devices - Resolution Number 185, 22 October 2001.
Not Applicable
BRAZIL
G/TBT/N/BRA/1241
Resolution 554, 30 August 2021.This resolution establishes the minimum requirements that Male Natural Rubber Latex Condoms must follow. This resolution internalizes the MERCOSUR/GMC Resolution No. 10/08, which establishes minimum requirements for Natural latex male condoms.
Not Applicable
BRAZIL
G/TBT/N/BRA/1154/Add.6
Resolution – RDC number 483, 19 March 2021 G/TBT/N/BRA/1154/Add.6 The Resolution number 483, 19 March 2021 - previously notified through  G/TBT/N/BRA/1154 - which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was changed by Resolution - number 561, 1 September 2021.
Not Applicable
BRAZIL
G/TBT/N/BRA/1112/Add.1
Resolution n. 448, December 10th, 2020. G/TBT/N/BRA/1112/Add.1 This Resolution n. 448, 10 December 2020 – previously notified through G/TBT/N/BRA/1112 - establishes temporary and extraordinary requirements for the fabrication, importation and commercialization of personal protective equipment identified as priority for use at health services, due to the Public Health Emergency of International Concern related to the SARS-CoV-2 pandemic was changed by Resolution n. 527, 5 August 2021.
Not Applicable
BRAZIL
G/TBT/N/BRA/842/Add.2
Resolution – RDC number 305, 24 September 2019 G/TBT/N/BRA/842/Add.2 The Resolution number 305, 24 September 2019 - previously notified through  G/TBT/N/BRA/842/Add.1 - which disposes about requirements for manufacturing, trading, importing and exposure to the use of personalized medical devices, was changed by  Resolution – number 562, 1 September 2021.
Not Applicable
BRAZIL
G/TBT/N/BRA/1203
Draft Resolution No. 1051 disposes the positive identification of medical devices regulated at Anvisa, through the Unique Identification of Medical Devices (UDI) system.
06/09/2021
BRAZIL
G/TBT/N/BRA/605/Add.4
Ordinance 384, 18 December 2020 that approves the Conformity Assessment and the Specifications for the Conformity Identification Seal for Equipment under the Health Surveillance Regime.
Not Applicable
CANADA
G/TBT/N/CAN/591/Add.1
Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices).
Not Applicable
BRAZIL
G/TBT/N/BRA/1112
Resolution number 444, 10 December 2020.
Not Applicable
ECUADOR
G/TBT/N/ECU/495
ARCSA-DE-032-2020-MAFG
Sanitary Technical Regulation for the certification of products for human use and consumption and their establishments, during the COVID-19 health emergency resulting from SARS-CoV-2.
Emergency
ECUADOR
G/TBT/N/ECU/498
ARCSA-DE-030-2020-MAFG
Substitute Sanitary Technical Regulation establishing guidelines for control of the traceability of medicines, biological products and medical devices.
Not Applicable
ECUADOR
G/TBT/N/ECU/499
ARCSA-DE-038-2020-MAFG
Substitute Technical Regulation for the issuing of regulatory administrative acts provided for in the functions of the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA), Doctor Leopoldo Izquieta Pérez.
Not Applicable
ECUADOR
G/TBT/N/ECU/498/Add.1
Substitute Sanitary Technical Regulation establishing guidelines for control of the traceability of medicines, biological products and medical devices.
Not Applicable
BRAZIL
G/TBT/N/BRA/992/Add.1
Amendment of the suspension of the compulsory certification of medical-hospital supplies for coping coronavirus pandemic (COVID-19).
Not Applicable
BRAZIL
G/TBT/N/BRA/1068/Add.1
Normative Instruction number 85, establishes technical requirements for medical devices selected to economic monitoring by Anvisa.
Not Applicable
BRAZIL
G/TBT/N/BRA/1069/Add.1
Normative Instruction number 84. List of medical devices selected to economic monitoring by Anvisa.
Not Applicable
ECUADOR
G/TBT/N/ECU/504
Draft Partial Amendment to the Sanitary Technical Regulation on good practices for storage, distribution and/or transportation for pharmaceutical establishments and establishments manufacturing medical devices for human use
20/06/21
BRAZIL
G/TBT/N/BRA/884/Add.2
Ordinance No. 176, 19 April 2021, which approves the consolidation of metrological regulation establishing the general guidelines and requirements for the model evaluation process.
Not Applicable
BRAZIL
G/TBT/N/BRA/443/Add.3
Ordinance: 84 – Approves the conformity assessment requirements for sterile hypodemic needles and sterile gingival needles for single use.
Not Applicable
BRAZIL
G/TBT/N/BRA/441/Add.3
Ordinance 84, 10 February 2021, that approves the consolidation of conformity assessment requirements for sterile hypodemic needles and sterile gingival needles for single use and revokes the Inmetro Ordinance 501, 29 December 2011.
Not Applicable
BRAZIL
G/TBT/N/BRA/1166
Public Consultation No. 1043 - Proposal to establish technical requirements for the import, commercialization, and donation of used reprocessed medical devices.
24/06/21
G/TBT/N/BRA/1166/Add.1 - Extends the deadline for 30 days
BRAZIL
G/TBT/N/BRA/1168
Public Consultation No. 1041 - Proposal to establish technical criteria for the concession or renewal of Good Manufacturing Practice Certificate for producers of medical devices.
31/05/21
BRAZIL
G/TBT/N/BRA/1167
Public Consultation No. 1042 - Proposal to establish technical requirements for the classification of orthopaedic implantable materials for the purpose of market authorization.
15/06/21

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