China’s New Device Catalog Makes Significant Classification Changes

Medical device manufacturers with products in China should check their current product portfolios against a new device catalog released by China’s Food and Drug Administration to develop transitional plans if any of their devices will be reclassified. Read More

China Looks West for Boost to Medical Device Industry

Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials. Read More

Australia Issues Update on Medical Device Reform

Australia’s Therapeutic Goods Administration released a status report on regulatory reforms for medical devices, including upcoming changes. Read More

Work Begins on New Medical Device Manufacturing Zone in India

India is moving ahead with a plan to boost its medical device manufacturing sector, and work has begun on a 270-acre state-of-the-art park in Andhra Pradesh dedicated to medical device manufacturing. Read More

Japan Builds Ties With International Regulators

Japan’s Pharmaceuticals and Medical Devices Agency has been ramping up its regulatory training activities with overseas regulators, and it inviting international regulators to a medical device seminar in Tokyo, Nov. 6-10. Read More

Australia Reports More Infections Associated with Heater-Cooler Devices

Australia’s Therapeutic Good Administration issued an update on its product review investigation of heater-cooler devices after more patients were found to be infected with Mycobacterium chimaera infections following heart surgery. Read More

Singapore Launches Device Priority Reviews, Pre-Market Consultations

Singapore is introducing a pre-market consultation scheme and a priority review mechanism for medical devices. Read More

Australia’s TGA Issues Guidance on Pre-Submission Meetings

Australia’s Therapeutic Goods Administration is urging devicemakers to meet with the agency before submitting conformity assessment applications. Read More

India Sets Price Controls for Knee Implants

Health authorities in India have imposed price caps on orthopedic knee implants. Read More

China’s High Court Pushes for Severe Penalties for Falsifying Device Clinical Trials

China’s high court called for severe criminal punishments for deliberately falsifying medical device clinical trial reports and other related documents,… Read More