SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

FDA 40

FDA Licensing Governance Compliance 40

SQA

APRIL 12, 2023

SQA Regulatory Surveillance Summary for February 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA Releases the Results of the 2022 Strategy, 31 January 2023 The ANVISA Strategy Performance and Results Evaluation Report is now available for consultation, for the year 2022.

FDA 40

FDA Compliance Pharmaceutical Industry 40

SQA

DECEMBER 16, 2022

The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of 01 March 2023. SQA Regulatory Surveillance Summary for September and October 2022. Agência Nacional de Vigilância Sanitária (ANVISA). China: National Medical Products Administration (NMPA). CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

DECEMBER 10, 2021

Based on these projections, Class IV device registrants would face a December 2023 deadline for UDI compliance. SQA Regulatory Surveillance Summary #6, 2021. Agência Nacional de Vigilância Sanitária (ANVISA). Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021.

FDA 52

FDA Compliance Public Health Hospitals 52