• 2026-04-01 03:38:31

Following the latest release of the "Procedures for Changes to Raw Materials of Medical Devices", PMDA has provided a side notice with Frequently Asked Questions (FAQs) and concepts for specifying raw materials in applications. In this article, we have extracted several questions that foreign manufacturers may need to pay attention to.

• 2026-04-01 02:52:37

This webinar recap summarizes a session organized by Qualtech on key EU MDR developments in 2026, including updated transition deadlines, EUDAMED implementation, and new requirements for Notified Bodies, along with upcoming regulatory reforms aimed at improving efficiency, transparency, and innovation.

• 2026-04-01 01:58:24

Musculoskeletal (MSK) conditions are a major health burden in Australia, ranking among the top 5 contributors to overall disease burden in 2024 and affecting nearly 7.3M people. Rising prevalence, aging demographics, and significant healthcare spending are driving growing demand for orthopedic technologies. As advanced solutions such as surgical robotics, smart implants, and regenerative therapies gain adoption, Australia's orthopedic sector continues to expand with increasing demand for innovative medical technologies.

• 2026-03-31 09:43:08

Qualtech's expansion into New Zealand, marked by the opening of our 15th office, highlights a market that combines accessible regulatory pathways with growing healthcare demand. With no pre-market approval required and a notification-based system, New Zealand offers an efficient entry route for medical devices. At the same time, increasing healthcare investment, aging population, and infrastructure development are driving demand for advanced medical technologies, positioning the market as a strategic opportunity within APAC.

• 2026-03-20 06:20:35

Meet us at CMEF 2026 in Shanghai to explore full lifecycle compliance services, integrated clinical trial capabilities, and streamlined global registration solutions. With local regulatory connections and multidisciplinary expert support, we offer on-site consultation and personalized guidance.

Visit our booth and book a one-on-one session in advance to plan your market access strategy!

• 2026-03-04 08:36:52

Join Qualtech's free webinar, "Medical Device Studies in the US: Regulatory Requirements, Study Design, and Best Practices in Subject Management" on March 26, 2026. This complimentary session is designed to provide clear and practical insights into US regulatory expectations, study design considerations, and effective subject management strategies.

Take advantage of this opportunity to strengthen your understanding of US medical device study requirements

• 2026-03-02 08:37:30

Celebrating 25 years of commitment and growth, Qualtech proudly reflects on the strength of our global offices and on-the-ground teams at the heart of our success. With consistent local execution across regions, we step into 2026 grounded in experience and strengthened by our international presence.

• 2026-03-02 02:28:47

Singapore's Smart Health initiative leverages technology to transform healthcare, addressing an aging population and driving demand for innovative medical devices. As a regional hub with high healthcare spending and import dependency, Singapore offers significant opportunities for med-tech companies focusing on digital health, AI, and assistive technologies. This article will highlight the insights for medical device businesses to leverage Singapore's Smart Health vision.

• 2026-02-26 08:25:34

The Malaysia Medical Device Authority (MDA) has officially gazetted the Medical Device (Designated Medical Device) Order 2026, effective on 1 June 2026. The Order involved medical device primarily used in aesthetic, therapeutic, and clinical settings. To enhance safety and mitigate risks, designated medical devices shall comply with Malaysian regulatory requirement for entering the Malaysian market.

• 2026-02-26 07:44:34

The Thai Food and Drug Administration (Thai FDA) and the Medical Device Authority (MDA) of Malaysia have initiated the Pilot Reliance Project, a joint effort to facilitate medical device registration by recognizing each othe's regulatory approvals. The pilot project is effective from February 2026 until 30 April 2026.