Tag: Medical Devices

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

Guiding Principles for Good Machine Learning Practice

October 29, 2021
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 identified 10 guiding principles that can...

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

September 8, 2021
Medical Device

The fast evolution of medical technology and the essential role of medical devices in the health care delivery system have highlighted the importance of ensuring the safety and effectiveness of these...

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

Unique Device Identification System

May 13, 2021
Medical Device

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented,...

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