December 14, 2018

China Releases Checklist to Guide Inspections of Device Trials

China’s National Medical Products Administration released a checklist for sponsors of device trials that places data integrity at the top of the list.

The authority said it developed the checklist in response to recurring problems seen during inspections.

The agency lists red flags that would indicate a problem with data authenticity, such as clinical trial data that is not traceable, failure to report serious adverse events, or clinical trial data submitted with the application that is inconsistent with data reported by the clinical trial institution.

The checklist covers quality management standards as well as device registration and good clinical practices. It includes on-site inspection elements that should be checked. Other topics covered include preparation for a clinical trial, informed consent, ethical reviews, clinical trial protocols, clinical trial reports and processes, recording clinical trial data and medical device test management.

India to Regulate Gowns, Drapes as Devices

The Indian government proposes to include surgical gowns and drapes as medical devices and the Medical Technology Association of India says it welcomes the change.

The group says the proposal by the Central Drugs Standard Control Organization (CDSCO) would ensure uniformity of quality in the products that were previously not regulated.

The association’s Director General, Pavan Choudary. says the group will work with its member companies to ensure compliance and to streamline the transition to the new requirements.

EU Member States to Work Together to Boost AI

The European Commission and EU member states agreed on a coordinated plan to foster the development and use of artificial intelligence in Europe, including for precision healthcare applications.

In 2019, member states will map out national AI research excellence centers and their core competencies to support EU-wide cooperation and networking.

The Commission will fund networks of AI research excellence centers with 50 million Euro ($56.5 million) in 2020, and it will make 390 million Euro ($441 million) available for developing platforms and large-scale pilots.

Beyond 2020, under the Digital Europe Program, the Commission will establish testing sites for AI-powered products and services throughout Europe.

Two big projects are expected to begin building a database of 1 million sequenced genomes accessible in the EU by 2022 and to develop a common database of health images initially dedicated to the most common forms of cancer.