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Singapore: Singapore Launches Cybersecurity Labelling Scheme for Medical Devices: Key Updates and Guidelines – December/January 2025

Singapore: Singapore Launches Cybersecurity Labelling Scheme for Medical Devices: Key Updates and Guidelines – December/January 2025

  • 2024-12-16 08:32:04

Following the Industry Consultation held from 25 January to 10 March 2023 and Sandbox Phase conducted from October 2023 to July 2024, the CSA, in collaboration with MoH, HSA, and Synapse launches the Cybersecurity Labelling Scheme for Medical Device [CLS(MD)] for public applications along with a set of publications as guidelines for the applicants. The program opens for voluntary enrollment on 16 October 2024 as part of Singapore's effort to enhance cybersecurity awareness.

Manufacturers who wish to pursue one of the 4 cybersecurity levels should apply to Cybersecurity Certification Centre (CCC) through GoBusiness Licensing Portal https://www.gobusiness.gov.sg while inquiries can be sent to email: cls_md@csa.gov.sg.

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Thailand: Thai FDA's Updated Guidance for SaMD/AI Medical Device Registration – December/January 2025

Thailand: Thai FDA's Updated Guidance for SaMD/AI Medical Device Registration – December/January 2025

  • 2024-12-16 07:05:36

Thai FDA has updated its guidance on the registration of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) medical devices. Key revisions include new requirements for establishment licensing, compliance with advertising regulations, and enhanced cybersecurity measures. The updated guidance offers stakeholders a clear framework for classification criteria, document preparation, and post-market responsibilities.

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USA: Performance Criteria for Safety and Performance Based Pathway on Various Dental Products – December/January 2025

USA: Performance Criteria for Safety and Performance Based Pathway on Various Dental Products – December/January 2025

  • 2024-12-16 05:25:54

The FDA has introduced the Safety and Performance-Based Pathway, offering an alternative route for device clearance by focusing on performance criteria rather than direct comparison to a predicate device. This approach simplifies submissions by emphasizing established safety and performance standards, ensuring effectiveness while reducing regulatory complexities.

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QT Activity: Introduction to India's Medtech Market Webinar Summary Recap – October/November 2024

QT Activity: Introduction to India's Medtech Market Webinar Summary Recap – October/November 2024

  • 2024-11-05 02:46:36

India's MedTech industry is quickly becoming a key player in global healthcare, driven by government initiatives, rising health awareness, and growing medical tourism. The India MedTech 2024 webinar, hosted by Qualtech Consulting, highlighted trends, challenges, and opportunities in the sector, featuring insights from expert Sandeep Shah. While the market, valued at $11-12 billion, still relies heavily on imports, there is a shift toward local manufacturing and innovation in digital health and AI. With growth prospects in domestic production and rural healthcare, the industry is poised to reach $50 billion by 2030.

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Combating a Growing Threat: Japan's Rise in Cancer – Increasing Demand for Advanced Treatments – October/November 2024

Combating a Growing Threat: Japan's Rise in Cancer – Increasing Demand for Advanced Treatments – October/November 2024

  • 2024-11-05 02:28:52

Japan is grappling with a growing cancer crisis, which has become the leading cause of death and is expected to increase significantly in the coming decades due to an aging population. To address this, Japan has strengthened its healthcare system by designating hundreds of hospitals as cancer care centers. The rising healthcare burden creates opportunities for innovative medical technologies to improve cancer diagnosis and treatment. With a strong focus on technological advancement and openness to foreign innovation, Japan presents a promising market for medical device manufacturers, where expert regulatory guidance is essential for success.

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Australia: TGA Issues Reminder on Advertising Rules for Therapeutic Goods: Key Guidelines for Social Media Compliance – October/November 2024

Australia: TGA Issues Reminder on Advertising Rules for Therapeutic Goods: Key Guidelines for Social Media Compliance – October/November 2024

  • 2024-11-05 02:13:00

The Therapeutic Goods Administration (TGA) has issued a reminder to manufacturers and marketers to comply with advertising rules for therapeutic goods, particularly on social media, following a rise in non-compliance cases. Key rules include ensuring ads are truthful, promoting only registered goods, adhering to endorsement guidelines, avoiding unapproved uses, clearly presenting risks and health warnings, and ensuring influencer content meets regulatory standards.

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Thailand: FDA ANNOUNCEMENT ON GUIDELINES SUBJECT TO CLASS 2, 3, AND 4 TECHNICAL DOCUMENTS TRANSFER AND REFER IMPLEMENTATION – October/November 2024

Thailand: FDA ANNOUNCEMENT ON GUIDELINES SUBJECT TO CLASS 2, 3, AND 4 TECHNICAL DOCUMENTS TRANSFER AND REFER IMPLEMENTATION – October/November 2024

  • 2024-11-04 08:50:30

Thai FDA introduced new guidelines for handling the registration of medical devices under Notified (Class 2 & 3) and Licensed (Class 4) Medical Device. Thai FDA permitted referencing of previously approved dossiers when applying for brand name changes ("Refer") and for the transfer of medical device licenses between medical device establishment ("Transfer"). This move aimed to streamline the regulatory process, reduce redundant dossier reviews, and simplify licensing in Thailand's medical device sector.

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