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Medical Devices-USA/Europe Regulatory News – Nov 2023

November 7, 2023
Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Swissmedic Device/IVD Database Key Dates

November 3, 2023
Medical Device

Swissmedic now handles registration of economic operators, medical devices and in vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments...

IVD Regulations, Medical Device Compliance, Medical Device Manufacturers, Regulatory Updates, Swissmedic

Consumer Health-USA/Europe/Asia/ROW Regulatory News – Oct. 2023

October 26, 2023
Consumer Health

USA Canada Three New Food Enzymes Granted Approvals On October 11, 2023, Health Canada unveiled NOM/ADM-0209 with immediate effect, modifying the List of Permitted Food Enzymes to enable the...

Consumer Health, cosmetics, FDA Updates, Healthcare Industry, Regulatory Changes, Regulatory News

Pharma/Biotech – Asia, ROW Regulatory News, Oct. 2023 Vol. 2

October 26, 2023
Biopharma

ASIA Pakistan DRAP outlines pharma implications of Pakistan’s hazardous waste policy The Drug Regulatory Authority of Pakistan (DRAP) has shared information about how national guidelines on...

Asia Regulatory News, BioTech, Pharma, Regulatory Updates, ROW Regulatory News

Medical Devices-Asia and ROW Regulatory News-Oct. 2023

October 18, 2023
Medical Device

ASIA INDIA The Indian Regulatory Authority (CDSCO) has released List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer...

ANVISA, Asia Regulatory News, Medical Devices, NMPA, Regulatory News, ROW Regulatory News, SaMD, SFDA

Understanding FDA Labeling Regulations

October 18, 2023
OTC

All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. FDA holds that labeling encompasses: Any written, printed...

Compliance Guide, Drug Labeling, FDA, Labeling Guidelines, Labeling Regulations