SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

FDA 40

FDA Licensing Governance Compliance 40

SQA

SEPTEMBER 2, 2022

On 09 May 2022, NMPA released the draft of the revised Regulations for Implementation of the Drug Administration Law (hereafter referred to as the Regulations ) for public comments. The Regulations were first issued with immediate effect in 2002 and were later revised in 2016.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

Health Law Advisor

AUGUST 10, 2023

FDA specifically identified the following as not having to register as device manufacturers: Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. [8] 8] We could go on, but hopefully you get the gist.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies. The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot.

FDA 52

FDA Compliance COVID-19 Public Health 52