Tag: Medical Devices

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

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...

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

Guiding Principles for Good Machine Learning Practice

Standards

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) have jointly outlined ten guiding principles to support...

artificial intelligence and machine learning, fda artificial intelligence, Guiding Principles for Good Machine Learning, Machine Learning-enabled medical devices, Medical Devices

Authorization of Medical Devices based on the ASEAN Harmonized Technical Requirements

Medical Device

The rapid advancement of medical technology and the growing importance of medical devices in healthcare have underscored the need for regulatory measures that ensure product safety and effectiveness...

asean harmonized technical, authorization of medical devices, harmonization technical, Medical Devices

Unique Device Identification System

Medical Device

distributed in the United States can be accurately identified from manufacturing through distribution and ultimately at the point of patient use. Once fully implemented, most device labels will display...

FDA requires medical device labelers, GUDID, Medical Devices, Medical Devices Labeling, UDI, Unique Device Identification System