MedTrainer

DECEMBER 7, 2023

State-specific governing bodies, such as the West Virginia Department of Health and Human Resources (DHHR) and the Bureau for Medical Services (BMS) , oversee and enforce these regulations. Effective management of healthcare compliance in West Virginia requires consistent adherence to both federal and state agency standards.

Compliance 52

Compliance Licensing Medicaid Medicaid 52

SQA

SEPTEMBER 2, 2022

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

FDA 91

FDA COVID-19 Nursing Homes Public Health 91

SQA

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. 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. Address gaps in existing compliance requirements.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

APRIL 30, 2021

In addition, considering the fact that one marketing authorization application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorization application is submitted under an abridged procedure (e.g., Under Article 82(1) of Regulation (EC) No. European Medicines Agency (EMA) – Biologics.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52