• 2026-04-01 07:01:44

The Medical Device Authority (MDA), Malaysia, announces two key updates for medical device registration. The latest labelling guidance introduces e-labelling requirements, while conformity assessments conducted by Singapore's Health Sciences Authority (HSA) are now recognized through a verification-based process. These updates aim to streamline registration and ensure compliance for medical devices in Malaysia.

• 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.

• 2026-03-31 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.

• 2026-01-30 07:13:08

Thailand has updated its medical device labeling and IFU regulation, which will take effect on June 20, 2026. The new regulations expand the scope to include Software as Medical Device (SaMD), reusable surgical and dental instruments, and medical device accessories. Manufacturers and Importers are granted transition period until June 20, 2028, to transition from the 2020 requirements to the new 2025 requirements. Medical device companies marketing products in Thailand must update their labeling and IFU to comply with this updated announcement by the enforcement deadline.

• 2026-01-20 03:48:00

Join Qualtech's free webinar "Expert Insights - EU MDR Updates 2026" on February 12, 2026, to gain practical insights and stay up to date with the most recent developments in the European Medical Device Regulation. This session will assist you and your organization to confidently navigate EU MDR requirements and prepare for the end of the transition period. Stay informed, stay compliant, and turn MDR challenges into opportunities.

• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.