Category: Medical Device

TGA: Regulatory Impact Statement – Proposed Regulatory Scheme for Personalised Medical Devices, Including 3D-Printed Devices

March 5, 2020
Medical Device

Technology changes have the potential to deliver significant advantages and opportunities to Australians. Ongoing advances are both disrupting and altering the health sector, where there is rapid change...

Danish Medicines Agency Recommended New Regulation for Application for a Clinical Trial Permit for Medical Devices

March 5, 2020
Medical Device

Danish Medicines Agency recommended a new regulation on medical devices (MDR 2017/745) is effective from 26 May 2020, new rules on clinical trials. Applications for clinical trials have to be processed...

Europe: Medical Device Incident Reporting

February 28, 2020
Medical Device

Each year, the regulatory authorities receive several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Incident Reporting...

Brazil – General Provisions for Stability Studies of Active Pharmaceuticals and Medicines

February 26, 2020
Medical Device

ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out stability studies of active pharmaceutical ingredients (IFAs), and of new, innovative, generic, similar,...

China’s CMDE Announces New Regulations on the Supervision and Administration of Customized Medical Devices for Clinical Trials

January 22, 2020
Medical Device

The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 53) that clarifies the requirements for the definition, listing, design, processing, usage, supervision...

China, Medical Device, Regulations

An Overview of European Unique Device Identification System

November 29, 2019
Medical Device

The Medical Device Regulations (EU 2017/745, EU 2017/746) introduce the Unique Device Identification (UDI) system to unambiguously identify medical devices within the global supply chain. The main...