SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The Therapeutic Goods (Medical Devices) Regulations 2002 now includes for Essential Principle 7.7:

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

AUGUST 10, 2023

Medical Device Data Systems Prior to FDA’s Mobile Medical App Guidance, this topic was addressed by FDA when it created the category of Medical Device Data Systems (“MDDS”). But those good intentions and the fact that their employer is engaged in health care do not exempt such innovators from FDA oversight. 7, 2002), at 21. [16]

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

FEBRUARY 26, 2024

The products had been improperly regularized in ANVISA as cosmetics since they are indicated for injectable use, a form that is not authorized for this category of product. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.

FDA 52

FDA Compliance COVID-19 Public Health 52