• 2025-09-24 09:35:21

On September 4, 2025, Qualtech hosted a webinar focusing on the medical device regulatory landscapes of Japan and South Korea. Led by our Japan and South Korea Registration Team Leaders, the session offered participants a structured overview of both markets, covering regulatory frameworks, registration pathways, and key updates shaping compliance today.

• 2025-09-24 08:47:47

The Ministry of Food and Drug Safety (MFDS) has announced amendments to both the Enforcement Rules of the Medical Device Act and the Medical Device Standards. The revisions, implemented between April and August 2025, included higher fees for innovative medical device reviews, exemptions from documentation requirements, stricter administrative sanctions, and the establishment of long-term follow-up requirements. In addition, amendments to the Medical Device Standards have been finalized and are scheduled to take effect in July 2026, introducing new standards and aligning existing ones with international norms.

• 2025-08-15 01:48:59

On September 4th, join Qualtech for an insightful webinar, "Entering Japan and South Korea: Understanding PMDA and MFDS Requirements for Medical Devices". This session will offer practical guidance on navigating the regulatory systems of Japan and South Korea – ideal for companies seeking to accelerate market entry and avoid compliance-related issues.

• 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.

• 2025-01-22 07:51:43

South Korea's rapidly aging population is driving a surge in chronic diseases, creating a lucrative market for medical devices. This article will highlight the growing demand for diagnostic tools, remote patient monitoring devices, wearable health trackers, cardiovascular and orthopedic devices, and diabetes care devices. With significant market projections, South Korea offers promising opportunities for foreign medical device manufacturers.

• 2024-12-16 09:42:20

South Korea is transforming healthcare with AI, enabling personalized nutrition, early disease detection, and proactive health management. AI systems, like one that diagnosed lung cancer with 94% accuracy, showcase its potential. The technology also accelerates drug development, opening new opportunities for AI-powered medical device companies.

• 2024-06-20 07:07:12

South Korea's medical device market is flourishing, driven by a surge in demand for advanced technologies. This trend, coupled with a high reliance on imports (67% in 2021), creates a promising opportunity for international manufacturers of innovative devices. However, navigating this dynamic market effectively requires a strategic approach to secure a foothold in this Asian powerhouse.

• 2024-06-20 06:42:03

South Korea boasts a thriving contact lens market. Driven by a high prevalence of myopia (nearsightedness) and a growing preference for stylish and functional eyewear, Korea presents a lucrative opportunity for global contact lens manufacturers. This article explores the factors fueling the Korean contact lens market, the reasons why it’s ripe for foreign investment, and the key considerations for success.

• 2024-03-01 08:29:27

Starting from 1 January 2024, Hong Kong Medical Device Division (MDD) has accepted on a regular basis marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea and National Medical Products Administration (NMPA) of Mainland China to support the listing application of medical devices in Hong Kong.

• 2023-11-20 03:05:02

On October 20, Qualtech hosted a webinar titled "Korea Market Expansion and China NMPA Updates." With over 60 global participants, the event marked Qualtech's entry into the Korean market, sharing actionable steps for successful medical device registration. The second segment covered key changes in China's Medical Device regulations from September 2022 to August, ensuring attendees were informed about the latest regulatory developments.