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Medical Devices-Asia and ROW Regulatory News – April 2023

April 18, 2023
Medical Device

ASIA INDIA (CDSCO) Circular for Licensing of Class C & D medical devices According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, SaMD, Software as a Medical Device

MDR Regulations – Impact on Medical Devices

April 18, 2023
Medical Device

The EU Medical Device Regulation (MDR) has been in effect since May 26, 2021 and has had a significant impact on the global medical device industry. Below mentioned are the 7 ways the...

AI-enabled and Human reviewed Regulatory Intelligence Tool

April 5, 2023
Digital Health

The creation, capture, and data consumption have increased by roughly 5000% in the last 12 years. As a result, businesses are finding that proper handling of that data involves far more processes than...

AI, Regulatory Compliance and Intelligence Tool, Regulatory Intelligence, Regulatory Monitoring, Regulatory Strategy

Pharma/Biotech – USA, Europe Regulatory News, April 2023 Vol. 1

April 5, 2023
Biopharma

USA FDA Issues Guidance on ISO Data Standards for Medicinal Products As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – April 2023

April 4, 2023
Medical Device

USA (FDA) Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act-Guidance for Industry and Food and Drug Administration...

Europe Regulatory News, FIMEA, HPRA, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News

FDA Authority Over Cosmetics

March 24, 2023
Cosmetics

Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin...

Cosmetic Labeling, Cosmetic Registration, FDA Cosmetics Regulations, Laws and Regulations, Product Safety