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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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Thailand: FDA Announcement on Guidelines subject to Technical Documents Transfer and Refer Implementation – October/November 2024

Thailand: FDA Announcement on Guidelines subject to 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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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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MALAYSIA: MDA releases Circular letter on Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions - July 2024

MALAYSIA: MDA releases Circular letter on Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions - July 2024

  • 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.

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SINGAPORE:  Streamlining Medical Device Approval in Asia: Singapore HSA is Recognized as Reference Country by Hong Kong MDD – June/July 2024

SINGAPORE: Streamlining Medical Device Approval in Asia: Singapore HSA is Recognized as Reference Country by Hong Kong MDD – June/July 2024

  • 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

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SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices CLS(MD) Sandbox - Latest Updates and Calls for Medical Device Manufacturers – June/July 2024

SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices CLS(MD) Sandbox - Latest Updates and Calls for Medical Device Manufacturers – June/July 2024

  • 2024-06-20 05:41:18

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.

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INDONESIA: New Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT) through Electronic Systems – June/July 2024

INDONESIA: New Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT) through Electronic Systems – June/July 2024

  • 2024-06-19 06:08:37

The Indonesian Ministry of Health recently issued guidelines to regulate the use of Medical Devices and Household Health Supplies through electronic systems. These guidelines, signed on 5 April 2024, offer crucial information for business actors, manufacturers, and distributors in the healthcare sector seeking to market their products in electronic systems.

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