Category: Medical Device

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

Medical Devices-USA/Europe Regulatory News-Feb 2023

February 2, 2023
Medical Device

USA (FDA) Surveying, Leveling, and Alignment Laser Products – Guidance for Industry and Food and Drug Administration Staff The guidance is intended to summarize FDA’s current thinking on...

Medical Devices-Asia and ROW Regulatory News-Jan 2023

January 19, 2023
Medical Device

INDIA (CDSCO) Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer In order to...

Asia Regulatory News, Baharain Regulatory News, China Regulatory News, Hong Kong Regulatory News, India Regulatory News, Malayasia Regulatory News, Medical Devices, Regulatory News, Saudi Arabia Regulatory News

Medical Devices-USA/Europe Regulatory News – Jan 2023

January 4, 2023
Medical Device

EUROPE MDCG 2022-21 – Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 The guidance is applicable to medical devices which have been certified under...

Europe Regulatory News, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News Roundup, Nov 2022

December 8, 2022
Medical Device

EUROPE 1. Updated information pack for candidate EU reference laboratories publishedRegulation (EU) 2017/746 empowers the European Commission to designate one or more EU reference laboratories for...

Canada Regulatory News, Europe Regulatory News, Ireland Regulatory News, Medical Devices News, UK Regulatory News, USA Regulatory News