Medical Devices
Page 2 • 6 itemsGain critical insights into global medical device regulatory pathways, market trends, and innovation impacting pharmaceutical R&D and commercialization.
Australia's TGA Updates In Vitro Diagnostic Device Regulations for Medical Device Manufacturers
Australia's Therapeutic Goods Administration releases comprehensive guidance for in vitro diagnostic device manufacturing, applications, and market authorization.
PMDA Approves Peripheral Rotablator PRO and Visual-ICE Cryoablation System Modifications in Japan
Japan's PMDA grants partial change approval for Peripheral Rotablator PRO and Visual-ICE Cryoablation System, expanding cardiovascular treatment options.
Australia's TGA Expands Therapeutic Vaping Access Through Pharmacy Channels with New Regulatory Framework
Australia's TGA establishes new pathways for therapeutic vaping products through pharmacies, expanding access to regulated e-cigarettes as therapeutic goods.
TGA Updates Medical Device Regulations for AI and Software-Based Therapeutic Products in Australia
Australia's TGA provides comprehensive regulatory guidance for medical devices including AI and software products through ARTG registration and manufacturing standards.
Phantom Neuro Receives Approval for First Human Trial of Phantom X Neural Interface System
Phantom Neuro gets approval for first-in-human trial of Phantom X neural interface system in Australia, marking major milestone for prosthetic control technology.
WuXi Biologics Achieves ISO 13485 Certification for Drug-Device Combination Products Manufacturing
WuXi Biologics becomes first in China to achieve ISO 13485:2016 certification with zero non-conformities for drug-device combination product development.