• 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.

• 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

• 2024-09-17 02:45:43

Medical devices often undergo numerous iterations to enhance the product based on real-world experience and feedback. These changes result in rebranded new products called Next Generation Medical Devices (NextGen MD). Health Sciences Authority (HSA) in Singapore has taken a proactive step by introducing the NextGen MD Initiative to facilitate the registration of next generation devices by streamlining the registration process to allow applicants to leverage data that has been submitted to HSA for registered devices.

• 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.

• 2024-09-17 02:03:36

The Minister of Finance promulgated Circular 43 /2024/TT-BTC dated June 28, 2024, which lowered fees to alleviate difficulties and support production and business activities.

• 2024-07-30 07:16:31

Japan's diagnostic imaging market is projected to grow at a CAGR of 6.28% from 2022 to 2027, becoming a major segment within the country's medical devices sector. The oncology segment is expected to lead this growth due to rising cancer incidences and technological advancements in diagnostic imaging, including AI and data automation, enhancing diagnostic and treatment processes.

• 2024-07-30 06:35:03

The demand for Remote Patient Monitoring (RPM) devices in Japan is surging, driven by technological advancements, an aging population, and a shift towards home-based care. The market, valued at $2.06 billion in 2024, is projected to reach $2.93 billion by 2029, growing at a CAGR of 7.26%. Key segments include cardiac and neurological monitoring devices. Government initiatives and the shift towards home-based care further support this growth, offering significant opportunities for medical device manufacturers.