• 2024-10-10 08:46:48

HSA's Medical Devices Cluster has released a draft of Guidance on Change Management Program (CMP) for stakeholders with consultation period from 26 August 2024 to 21 October 2024. The new optional regulatory pathway aims to accommodate the rapid iterative nature of SaMD changes. This guidance explains on the CMP definition, scope, eligibility, requirements, and process. The guidance also introduces the concept of 'Pre-specified' changes. Feedback on the guidance draft can be sent to HSA through email by using prescribed feedback form.

• 2024-10-10 08:23:53

The Thai Food and Drug Administration (FDA) has initiated a registration process for Mpox diagnostic test kits in response to rising concerns over the spread of the viral infection. This move aims to enhance early detection and management of Mpox cases, ensuring public health safety. The Thai FDA has streamlined the registration process for manufacturers and importers, focusing on quality and accuracy of the diagnostic kits. This initiative is a key step in Thailand's efforts to curb the spread of the virus and strengthen its response to emerging health threats.

• 2024-10-10 08:07:48

The FDA launched the Voluntary Malfunction Summary Reporting (VMSR) program in 2018 to streamline the malfunction reporting process for medical device manufacturers. This initiative enhances the FDA's capacity to effectively monitor a diverse array of devices.

• 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.