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Description of content
Comment deadline
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
BRAZIL
G/TBT/N/BRA/1154/Add.3
Resolution number 483, 19 March 2021 which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was amended by Resolution – RDC number 516, 2 June 2021.
Not Applicable

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