Blog Category: Medical Device

Medical Devices–Asia Regulatory Updates Roundup–Nov 2021

Medical Device

JAPAN (PMDA) MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021) No. 387 The Ministry of Health, Labour and Welfare (MHLW) has released the latest Pharmaceuticals and Medical...

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

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

Categorization and Registration Process for Devices in EUDAMED

Medical Device

Device Categorization Devices submitted for registration in EUDAMED fall under the following categories: Regulation Devices – These include medical devices and in vitro diagnostic (IVD) devices...

Categorization and Registration Process, Categorization of devices to be registered in EUDAMED, eudamed device registration, medical device labeling requirements, Registration Process for Regulation Devices

Guidance on Premarket Submission for Device Software Functions

Medical Device

This draft FDA guidance outlines the recommended documentation that should accompany premarket submissions containing device software functions. It applies to both software in a medical device (SiMD)...

FDA Medical Device clinical Regulations, fda submission guidance, guidance document pertain to device software functions, Guidance on premarket submission, Medical Device, software design specification medical device, software in a medical device

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

Medical Device

EUROPE 1. 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

Medical Device

Philippines(FDA) 1.FDA Circular No.2021-0021: Guidelines on the Licensing of Retailers of Medical Devices in the Philippines This Circular is designed to: Specify the establishments classified...

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

Blog Category: Medical Device

Medical Devices–Asia Regulatory Updates Roundup–Nov 2021

Categorization and Registration Process for Devices in EUDAMED

Guidance on Premarket Submission for Device Software Functions

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

Medical Devices – Asia Regulatory Updates Roundup – Oct 2021

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