• 2025-03-25 09:14:44

South Korea's newly enacted Digital Medical Products Act (DMPA) establishes a dedicated regulatory framework for AI-driven devices, digital therapeutics, and health apps, ensuring their safety, effectiveness, and quality. Taking effect in January 2025, the Act introduces risk-based classifications, software and cybersecurity requirements, and clear pathways for digital health product approvals, positioning Korea as a global leader in digital health regulation.

• 2024-11-04 05:15:38

The US FDA has issued draft guidance outlining recommended methods for chemical analysis in the biocompatibility assessment of medical devices. It advises manufacturers to use targeted analytical techniques to identify and quantify chemical constituents, focusing on both device material composition and potential patient exposure.

• 2024-06-27 05:11:25

This article provides a comprehensive guide on TGA sponsors, a critical partner for medical device companies seeking to enter the Australian market. It explains the role of the Therapeutic Goods Administration (TGA) and how a TGA sponsor acts as a liaison, navigating the complex regulatory process to ensure compliance.

• 2023-12-28 09:01:53

In this latest edition, we navigate the evolving landscape of medical device regulations, marked by progress and heightened vigilance. The improvement of technology and healthcare is making things better for patients, but it also needs careful supervision. Over the past year, global regulatory bodies have demonstrated adaptability, reinforcing frameworks to manage medical device registrations effectively.

This edition offers a concise analysis of the latest mandates, impending updates, and pivotal shifts for 2024, addressing the exchange between technological innovation and the mission to ensure global safety and efficacy.

• 2023-10-27 01:27:54

South Korea's thriving medical device industry offers promising opportunities for companies, driven by a robust healthcare infrastructure, a growing aging population, government support, and rising healthcare spending. Qualtech invites interested manufacturers aiming to enter this dynamic market to partner with Qualtech to successfully navigate the approval process and maximize the product's potential.

• 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

• 2023-06-28 09:59:48

Qualtech's big topic for this month's edition provides an overview of the Unique Device Identification (UDI) system implemented by territories serviced by Qualtech for medical devices. The UDI system aims to improve patient safety, traceability, and identification of medical devices on the market. The implementation of the UDI system offers benefits such as faster traceability, standardized post-market safety activities, and improved buying and waste disposal policies.

• 2023-05-24 07:33:47

Qualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.

• 2023-04-25 02:16:08

Asian medical tourism has grown in popularity in recent years. With a global market share of more than 35%, its market size is predicted to rise at a 15% annual rate. The world's population is aging and increasing wealthy at a rate that high-quality healthcare cannot keep up with. Patients are seeking cross-border healthcare for these reasons. Asian healthcare providers offer world-class medical facilities, highly skilled doctors and medical workers, and a wide range of treatments and procedures at affordable prices. In this article, we will therefore look at Asia's medical tourism business and provide a comprehensive guide.

• 2023-01-19 06:48:57

The development of medical devices is significantly influenced by the rapid pace of technology. While these cutting-edge devices may improve healthcare services, they also pose major risks to public health and safety. Due to this, regulatory agencies throughout the world have been continuously developing and updating their regulations to strengthen their management of product registration and mandate that applicants submit more detailed documentation. This article will cover the recently issued, upcoming, and influential worldwide medical device regulation updates for the year 2023 in various countries.