SQA Regulatory Surveillance Summary | Monthly Update 2023 – February
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. The document details the evaluation of […]
SQA Regulatory Surveillance Summary | Monthly Update 2023 – January
SQA Regulatory Surveillance Summary for January 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner China: National Medical Products Administration (NMPA) NMPA Announcement on putting into use the electronic certificates of Documentation for Export of Active Pharmaceutical Ingredients (APIs) to the European Union (EU) and Certificate of a Pharmaceutical Product (No. 95, 2022), 08 November […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October
SQA Regulatory Surveillance Summary for September and October 2022 Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022 ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. The 20-page Q&A document covers general and specific topics including the importation of cannabis […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – July/August
SQA Regulatory Surveillance Summary for July and August 2022 Health Canada Counterfeit COVID-19 Antigen Rapid Test Kits Found in Ontario, 05 August 2022 Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – June
By Laurel Hacche & Debra Cortner SQA Associates SQA Regulatory Surveillance Summary 2022 – June Agência Nacional de Vigilância Sanitária (ANVISA) Brazil’s ANVISA Repeals Medical Device Regulations Related to The Coronavirus Pandemic, 20 May 2022 ANVISA published the RDC 702/2022, which repeals some requirements that were instituted to speed market approval of devices needed to […]
Environmental Monitoring Program Updates | SQA Regulatory Surveillance – May 2022
Environmental Monitoring Program Updates | SQA Regulatory Surveillance – May 2022 This monthly update reviews regulatory developments that influence environmental monitoring program design, execution, and compliance across regulated industries. By Laurel Hacche & Debra Cortner SQA Associates Health Canada, Non-Compliant Drug Inspections, 1Q 2022 Health Canada published the following non-compliant drug inspections in the first […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring
Recent regulatory actions affecting drug-device combination products continue to shape global compliance strategies for life-science manufacturers. By Laurel Hacche & Debra Cortner SQA Associates SQA Regulatory Surveillance Summary 2022 – Spring Agência Nacional de Vigilância Sanitária (ANVISA) Brazil’s ANVISA Issues Registration Rules for Software, 01 April 2022 ANVISA has published new regulations focused on software […]
SQA Regulatory Surveillance Summary 6 | Monthly Update 2021
By Laurel Hacche & Debra Cortner SQA Associates 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 ANVISA has rolled out its proposed framework for Unique Device Identification (UDI) requirements. According to ANVISA Public Consultation 1051/2021, the regulator […]
SQA Regulatory Surveillance Summary 5 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #5, 2021 International Organization for Standardization (ISO) Extra Guidance on Food Safety: A New Handbook to Accompany ISO 22000 Has Just Been Published, 09 March 2021 Keeping food safe involves the combined effort of every single player in the food production […]
SQA Regulatory Surveillance Summary 4 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #4, 2021 Agência Nacional de Vigilância Sanitária (ANVISA) Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices, 26 March 2021 ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference […]