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

March 7, 2023
Biopharma

US FDA Offers Advice on Macular Degeneration Drug Trials The FDA outlined drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance....

Biotech Regulatory News, EU Regulatory News, Pharma Regulatory News, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – March 2023

March 2, 2023
Medical Device

USA (US FDA) Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)-Guidance for Industry and Food and Drug Administration Staff The guidance...

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

Medical Device and Restricted Hazardous Substances

February 28, 2023
Medical Device

RoHS stands for Restriction of Hazardous Substances, and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated...

Medical Device, Restricted Hazardous Substances, RoHS, RoHS Certification, RoHS Testing

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

February 21, 2023
Biopharma

Asia India WHO calls for action after Asia-made medicines linked to 300 deaths Regulators must take immediate and coordinated action to stop the supply of contaminated over-the-counter cough...

Asia Regulatory News, Australia Regulatory News, BioTech, India Regulatory News, Japan Regulatory News, Malayasia Regulatory News, Pharma, Regulatory Updates, ROW Regulatory News, Saudi Arabia Regulatory News, Singapore Regulatory News

Medical Devices-Asia and ROW Regulatory News-Feb 2023

February 16, 2023
Medical Device

CHINA (CFMDE-NMPA) Announcement of the State Food and Drug Administration on Issuing YY/T 1888-2023 “Recombinant Humanized Collagen” Medical Device Industry Standard (2023 No. 14) The...

Asia Regulatory News, Baharain Regulatory News, China Regulatory News, Malayasia Regulatory News, Medical Devices, Panama Regulatory News, Philippines Regulatory News, Regulatory News, Saudi Arabia Regulatory News

Medical Device Labelling Requirements

February 13, 2023
Medical Device

The safe operation of a medical device must never come down to guesswork or trial and error. Informative, accurate labeling is required, and every label included with the device has to meet the applicable...

Code of Federal Regulations, EU MDR, General Device Labeling, In Vitro Diagnostic, Medical Device Labelling, Medical Device Regulation, Unique Device Identification, US FDA