Blog Category: Medical Device

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

Medical Devices-Asia Regulatory News Roundup, Nov 2022

December 8, 2022
Medical Device

INDIA (CDSCO) 1. List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017This Directorate...

Asia Regulatory News, Bahrain Regulatory News, India Regulatory News, Malayasia Regulatory News, Medical Devices Regulatory News

Medical Devices – USA, Europe, Asia Regulatory News – Nov 2022

November 30, 2022
Medical Device

Asia Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration with Approval by The NRA of Any ASEAN Member Country Philippines FDA issues Circular No. 2022-008...

Asia, Devices, Europe, FDA, HSA, IVDR, Liver Cancer, MDCG, Regulatory News, South Africa, USA

EU MDR Regulations

November 22, 2022
Standards

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices,...

EMA, EU MDR, EU MDR Regulations, EUDAMED, MDR

Medical Devices–USA/Europe Regulatory Updates Roundup, Oct 2022

November 8, 2022
Medical Device

EUROPE MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 The document has been endorsed by the Medical Device Coordination Group...