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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

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

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

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...

Medical Devices – Asia Regulatory Updates Roundup, Oct 2022

November 3, 2022
Medical Device

INDIA (CDSCO) Extension of last date for filing statutory forms prescribed under DPCO, 2013-reg As several representations requesting for extension of last date for filing statutory Forms- III,...

Medical Device – Regulatory & Product Intelligence

November 2, 2022
Medical Device

The Medical Device industry is one of the largest industries in the healthcare sector, with significant growth in the last few years. The industry is undergoing continuous transformation to comply...