SQA

OCTOBER 18, 2023

The inspection was motivated by complaints received by health surveillance agencies located in different Brazilian states, which reported on irregularities related to the composition of the companies’ products and divergences related to the labeling information of manufacturers and those responsible for the products.

FDA 40

FDA Compliance Licensing World Health 40

SQA

DECEMBER 16, 2022

ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022. Brazil’s ANVISA Announces Major Medical Device Registration Updates, 16 September 2022. The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of 01 March 2023.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

AUGUST 2, 2021

ISO/TS 22421, Sterilization of Health Care Products – Common Requirements for Sterilizers for Terminal Sterilization of Medical Devices in Health Care Facilities , provides high-level, overarching requirements and respective test methods, and sets the scene for further, more detailed standards to be developed.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

Agents inspected the luggage of travelers who crossed the land borders between Brazil and Paraguay (International Friendship Bridge) and Brazil and Argentina (Tancredo Neves Bridge). After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. and Biometik Indústria e Comércio de Cosméticos.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. So far, the would-be liability expanders haven’t done very well. 1145, 1165 n.135

Governance 52

Governance Payment Systems Hospitals Licensing 52