• 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.

• 2024-07-30 06:21:21

In recent years, Ho Chi Minh City, Vietnam has emerged as a leading destination for medical tourism. A rapidly developing healthcare ecosystem in Vietnam, with high demand and government incentives, creates a strong market for advanced medical service and associated devices.

In this article, Qualtech explores the development of medical tourism in Vietnam and its influence in the local medical device market.

• 2024-07-30 05:11:43

The Therapeutic Goods Administration (TGA) of Australia recently released a guidance document to clarify the distinction between cosmetics and therapeutic goods. This distinction is crucial as it determines the regulatory requirements that apply to a product.

• 2024-07-30 03:35:49

The Medical Device Authority (MDA) announced the applications for medical device re-registration must be submitted online using MeDC@St 2.0+, in accordance with the Guidelines for Re-Registration of Registered Medical Devices (MD/GL/08). One year prior to the certificate expiration date, the system will display a re-registration option enabling the establishments to submit their applications.

• 2024-07-30 03:14:40

The Medical Device Authority (MDA) enforced the policy of medical devices imported from or exported to countries without diplomatic relations with Malaysia that are subject to trade restrictions. This policy was approved during the MDA Member Meeting No. 1/2024 and has been effective since April 26, 2024, under Circular Letter No. 1/2024.