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… read more →
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… read more →
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… read more →
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… read more →
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… read more →
Wins & Challenges Summer Greetings! I’m happy to write this as I’m being thoroughly entertained by all the athletes competing for the Gold from countries around the world. So crazy… read more →
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… read more →
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… read more →
Wins & Challenges Spring greetings! First I want to convey my best wishes to all the Mothers out there for the recent Mother’s Day! We had a great time celebrating… read more →
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… read more →