Tag: Medical Devices

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 round up Dec-2021

January 11, 2022
Medical Device

EUROPECommission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards...

Canada regulatory updates, Europe Regulatory Updates, Medical Devices, Regulatory Updates, US FDA

Medical Devices–Asia Regulatory Updates Roundup–Nov 2021

December 15, 2021
Medical Device

Japan(PMDA) MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) No. 387 At the This Pharmaceuticals and Medical Devices Safety Information (PMDSI) publication is issued reflective...

Asia Regulatory Updates, asia regulatory updates roundup, clinical consulting services to biopharma, medical device companies, Medical Devices, Regulatory Updates

Reclassification of Spinal Implantable Medical Devices

December 3, 2021
Medical Device

This guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements. All spinal implantable medical devices are...

changes to medical devices, Medical Devices, new regulatory requirements, quality management systems, spinal implantable medical devices, technical documentation related to each device

Medical Devices – USA/Europe Regulatory Updates round up – Oct 2021

November 5, 2021
Medical Device

EUROPE1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents questions and answers...

EU Medical Device clinical Requirements, Europe Regulatory Updates, FDA Medical Device clinical Regulations, medical device labeling requirements, Medical Devices, Regulatory Updates, USA Regulatory Updates

Medical Devices – Asia Regulatory Updates Roundup – Oct 2021

November 3, 2021
Medical Device

Philippines(FDA) 1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the PhilippinesThis Circular aims to: Specify the establishments classified as retailers...

Asia Regulatory Updates, Asia regulatory Updates round ups, China NMDA, India CDSCO, Japan FDA, Medical Devices, Philippines FDA, Regulatory Updates