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Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for medtech companies entering China, explains how medtech companies can use a new guideline from the China FDA to help secure fast track approvals for innovative medical devices.Read More
Every medical device imported into Malaysia for sale must have a single authorized representative, according to a new circular from the country’s Medical Device Authority. Read More
Malaysia’s Medical Device Authority (MDA) has established an expedited review process for medical devices already approved in other jurisdictions including the U.S., Canada, Australia, the EU, and Japan. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for medtech companies entering China, explains how medtech companies can use a new guideline from the China FDA to help secure fast track approvals for innovative medical devices.Read More
The China Food and Drug Administration (CFDA) has released a long-anticipated draft Classification Catalog of Medical Devices that contains more specific categories and provides clearer guidance to manufacturers. Read More
Australia’s Therapeutic Goods Administration has issued safety alerts for Medtronic Australasia’s cardiac resynchronisation therapy defibrillators (CRT-Ds), Fresenius Medical Care Australia’s Seep-Safe tubing systems. Read More
Hong Kong’s Department of Health issued safety alerts for Synthes GmbH’s PFNA Blade Impactor, Boston Scientific’s Imager II Angiographic Catheter and Express LD Biliary Stent. Read More
Australia’s TGA has issued hazard alerts for Microport Orthopedics metal-on-metal (MoM) hip implant components and Mathys Orthopaedics balanSys unicompartmental convex polyethylene inlays. Read More
Australia’s TGA has issued a warning and halted a clinical study of St. Jude Medical’s Nanostim leadless cardiac pacemakers due to battery malfunctions. Read More
Draft clinical evidence guidelines for medical devices published by Australia’s Therapeutic Goods Administration (TGA) should deemphasize the use of literature reviews and equivalence determinations, and instead focus on clinical evidence specific to particular devices, commenters said. Read More