• 2024-09-17 06:26:38

Japan's thriving healthcare market, driven by innovation and growth in medical technology, offers unparalleled opportunities for medical device manufacturers. Qualtech Consulting provides expert regulatory and clinical evaluation services to help you navigate this complex landscape and successfully enter the East Asian market.

• 2024-09-17 06:17:58

Australia's TGA has issued new guidelines for exempt medical devices, clarifying that while not requiring ARTG registration, these products still face strict oversight. Manufacturers must adhere to reporting, recall, advertising, and quality standards to ensure patient safety. Non-compliance can result in penalties.

• 2024-09-17 06:13:22

The Therapeutic Goods Administration (TGA) plays a critical role in ensuring the safety and efficacy of medical devices in Australia. In line with its mandate, the TGA has released a guidance on Essential Principle 13B, to guide manufacturers with medical device products incorporating software.

• 2024-09-17 05:57:50

Australia's TGA has issued two new guidance on software-based medical devices. Sponsors must comply with the new classification rules with the transition period ending by November 1, 2024. Additionally, the TGA clarified which software products are subject to regulation, providing clear guidelines for industry.

• 2024-09-17 05:40:30

NMPA issued a notice that administrative paperwork for some registration matters will become electronic versions starting June 1, 2024.

• 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.

• 2024-09-17 05:14:36

Hong Kong's Department of Health will be implementing an enhanced two-staged strategy following the previous phase, to prioritize Medical Device Administrative Control System (MDACS)-listed medical devices in public healthcare facilities procurement. This article outlines the new requirements, and how to navigate the impacts.

• 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

• 2024-05-08 01:49:59

In April 2024, Hong Kong Medical Device Division has introduced the new Medical Device Information System, a one-stop e-service that allows online Medical Device Administrative Control System listing applications for medical devices and traders. It is highly recommended to familiarize with the new e-services, as we transition out of paper-based submissions.