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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

Vistaar Regulatory Intelligence

December 2, 2022
Standards

VISTAAR provides Global regulatory submission requirements, guidance documents, updates, news and other regulatory details to Biopharma, Medical Devices, Digital Health, Diagnostics, Consumer Health...

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

Artificial Intelligence Based Regulatory Intelligence database

November 9, 2022
Digital Health

Artificial Intelligence, BioPharma, Consumer Health, Diagnostics, Digital Health, Medical Devices, OTC, Regulatory Intelligence