Tag: Regulatory Updates

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

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

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

October 6, 2021
Medical Device

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

Europe, Europe FDA, Europe Medical Devices, Europe Regulatory Updates, FDA Updates, Medical quality, medicaldevice, Regulatory Updates, USA, Usa Medical Devices, USA Regulatory Updates

Medical Devices-Asia Regulatory Updates round up-Sep 2021

October 6, 2021
Medical Device

China (NMDA) 1. 2th China International Medical Device Regulatory Forum held in WuhanSponsored by the China Center for Food and Drug International Exchange (CCFDIE), the 12th China International...

China, hongkong fda, india, Medical quality, medicaldevice, Philippines FDA, Regulatory intelligence software, Regulatory Updates, vistaar