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 […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – May
By Laurel Hacche & Debra Cortner SQA Associates SQA Regulatory Surveillance Summary 2022 – May Health Canada Health Canada, Non-Compliant Drug Inspections, 1Q 2022 Health Canada published the following non-compliant drug inspections in the first quarter of 2022: EGS EuroCam, inspected on 11 January 2022: findings relate to quality control, personnel, premises, equipment, raw material […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring
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 as a medical device (SaMD), set to take effect on 01 July 2022. ANVISA’s RDC 657/2022 (link in […]
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 […]
SQA Regulatory Surveillance Summary 3 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #3, 2021 European Commission (EC) – Biologics Commission Extends Transparency and Authorization Mechanism for Exports of COVID-19 Vaccines, 11 March 2021 The EC has extended until the end of June 2021 the transparency and authorization mechanism for COVID-19 vaccine exports. This […]
SQA Regulatory Surveillance Summary 2 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #2, 2021 International Organization for Standardization (ISO) Clinical Investigation of Medical Devices for Human Subjects, ISO 14155:2020, November 2020 ISO 14155:2020 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to […]
SQA Regulatory Surveillance Summary 1 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary, #1 2021 Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA has Published its Annual Management Plan (PGA) for 2021, which Comprises 61 Goals and Actions, 16 December 2020 The driving principles of the ANVISA Annual Management Plan (PGA) are to increase efficiency, […]