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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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Qt Promotion: Unlocking Growth in ASEAN's Booming Healthcare Market - September/October 2024

Qt Promotion: Unlocking Growth in ASEAN's Booming Healthcare Market - September/October 2024

  • 2024-10-10 10:03:44

The ASEAN region is rapidly emerging as a vital player in the global healthcare industry, offering immense opportunities for growth and expansion. For medical device companies looking to enter this dynamic market, partnering with Qualtech Consulting Corporation provides the expertise, support, and local knowledge necessary to navigate the complexities of regulatory approval and achieve success. Don't miss the chance to expand your business in one of the world's most exciting healthcare markets—let Qualtech guide you every step of the way.

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Revolutionizing Indonesia's Healthcare Landscape – An Insight into Government Mega Projects and the Medical Device Market - September/October 2024

Revolutionizing Indonesia's Healthcare Landscape – An Insight into Government Mega Projects and the Medical Device Market - September/October 2024

  • 2024-10-10 09:41:55

Indonesia is transforming its healthcare system through three major government projects: SIHREN, SOPHI, and INPULS. These initiatives aim to improve healthcare services, enhance access to specialized care, and strengthen the public laboratory system, addressing major diseases like cancer and heart disease. The projects also present significant opportunities for medical device manufacturers and regulatory consultants to align their offerings with Indonesia’s evolving healthcare needs.

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Singapore: Consultation on Guidance of Change Management Program (CMP) for SaMD – September/October 2024

Singapore: Consultation on Guidance of Change Management Program (CMP) for SaMD – September/October 2024

  • 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.

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Thailand: Thai FDA Implements Urgent Registration for Mpox Test Kits Amid Growing Public Health Concerns – September/October 2024

Thailand: Thai FDA Implements Urgent Registration for Mpox Test Kits Amid Growing Public Health Concerns – September/October 2024

  • 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.

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