• 2025-08-25 07:56:48

On July 21, 2025, Qualtech hosted a webinar featuring Mobius Medical's Co-Founder and Clinical Director, Stefan Czyniewski, on "Accelerating Innovation: Why Australia Is the Ideal Partner for Your Next Clinical Trial". The session emphasized Australia’s speed and cost-efficiency under the Clinical Trial Notification (CTN) scheme, world-class infrastructure, and broad international acceptance of trial data. Key comparisons with the United States highlighted faster start-up timelines, simpler regulatory pathways, and substantial financial incentives such as the R&D Tax Rebate. With its favorable environment for early-phase medical device and diagnostic studies, Australia stands out as a strategic launchpad for global clinical development.

• 2025-07-14 01:44:36

The NMPA issued the Catalog of Medical Devices Exempt from Clinical Evaluation (2025), which took effect on May 12, 2025.

• 2025-07-07 08:26:29

Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.

• 2025-04-24 08:15:56

The National Medical Products Administration has organized and revised the Key Points and Determination Principles for the Inspection of Medical Device Clinical Trial Projects, which will come into effect on May 1, 2025.

• 2025-01-22 07:00:59

This guidance provides instructions for sponsors on submitting clinical investigation reports and their summaries to Member States' competent authorities when EUDAMED is not fully functional.

• 2024-09-17 05:26:27

The National Medical Products Administration (NMPA) and National Health Commission (NHC) have issued guidelines for the temporary importation of urgently needed medical devices in clinical settings. The regulation streamlines import processes while ensuring compliance with safety standards, allowing medical institutions to quickly access essential, unregistered devices. It aligns with NMPA Orders No. 47 and 48, emphasizing patient safety and timely access to critical medical equipment.

• 2024-09-17 05:23:25

This guidance offers instructions on the clinical evaluation of orphan devices under the MDR.

• 2024-06-20 05:24:57

This guidance outlines the requirements for sponsors submitting applications for clinical investigations and supports sponsors in developing the Investigator's Brochure.

• 2024-05-08 03:00:06

CMDE has issued a new notice, supplementing previous recommendations with updated clinical evaluation paths for specific medical devices, aiming to guide registration applicants effectively in navigating the regulatory process.

• 2024-05-08 02:32:34

This guidance provides detailed instructions to assist sponsors in preparing plans that fulfill regulatory expectations and streamline the assessment process by competent authorities.