SQA News | Spring 2023
Wins & Challenges I’m so excited to give everyone an update on some big news that’s happened over the last six months! Big wins for SQA and some challenges along the way and a new chapter in my life moving forward. As you likely read in our press release in late ’22, I’ve transitioned to […]
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 products, […]
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 appoints new President/CEO, Michael Guymon: “SQA’s New Face of Quality”
Los Angeles, CA, October 18, 2022 – Today, SQA Services, Inc. announced Michael Guymon has been appointed as the new SQA President and Chief Executive Officer (CEO). Guymon succeeds Mike McKay, who was appointed Co-Chairman after serving as President and CEO for the past 27 years. “I feel privileged to take on the role of […]
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 News | Summer 2021
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 seeing empty stands while dreams are realized but I must commend Tokyo for a largely uneventful Olympics and Paralympics given the current myriad of Covid […]