SQA Regulatory Surveillance Summary for March and April 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner Agência Nacional de Vigilância Sanitária (ANVISA) ANVSA Recommends Intensification of Actions Against Arboviruses, 22 March 2023 ANVISA has published Technical Note 12/2023 which recommends the intensification of measures or the reduction of mosquito breeding sites and control of adult vectors, airports, and border areas, which are points of entry and exit of the country. The objective is to reinforce actions for the prevention and control of diseases such as dengue and chikungunya ..read more

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 the implementation of actions provided for the Strategic Plan (PE) 2020 to 2023 and the Annual Management Plan (PGA). The first instrument consists of a set of 41 strategic goals and 17 strategic projects, while the second ..read more

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 2022 As part of the effort to implement the major decisions and plans of the Communist Party of China Central Committee and the State Council on deepening the reforms to separate operating permits from bu ..read more

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, simplified authorization procedures for education, and research institutions that a ..read more

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 without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. products in color and typeface and uses the BTNX Inc. device i ..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 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 treat patients during the height of the COVID-19 pandemic. Resolution RDC 702/2022 became effective on 22 May 2022 and repeals the following: RDC 349/2020: the temporary criteria and procedures for regularization of ..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 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 testing, sanitation, manufacturing control, and records (EGS EuroCam Observations) West Penetone Inc., inspected on 25 January 2022: findings relate to premises, manufacturing control, quality control, sanita ..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 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 Portuguese) covers registration requirements for SaMD, for which Brazilian regulators had not previously issued specific rules. The new RDC 657/2022 makes clear which software types do not fall under the ne ..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 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 plans a six-year rollout of UDI requirements in order to boost traceability and monitoring of medical devices and equipment commercialized in Brazil. UDI compliance lead times for m ..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 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 chain, from farm to fork. That means everyone needs to be speaking the same language and adhering to the same rules. ISO 22000 is an internationally agreed reference in the food industry, and now new guidance has just been p ..read more