• 2026-04-02 02:37:23

Decree No. 37/2026/ND-CP introduces updated labeling requirements in Vietnam, replacing previous regulations. It strengthens and supplements the rules on mandatory label information, while also introducing additional provisions on electronic labeling and specific requirements for medical devices. Transitional provisions are included to support the continued use of previously compliant labels for a limited period.

• 2026-04-02 01:20:01

Health Sciences Authority (HSA) has responded to feedback from its public consultation on a proposed regulatory sandbox that exempts selected low‑risk artificial intelligence software as a medical device (AI‑SaMD) from manufacturer licensing and product registration requirements under controlled conditions. The sandbox aims to balance regulatory oversight and innovation by allowing public healthcare institutions to develop and deploy AI tools for non‑critical medical conditions while collecting real‑world insights to inform future regulatory frameworks.

• 2026-04-01 07:49:34

Qualtech invites you to a free webinar on April 17, 2026, on mastering Technical Documentation under the EU Medical Device Regulation (MDR). Regulatory expert Dr. Arkan Zwick will share practical guidance on MDR documentation, Annex XVI requirements, legacy device transitions, and working with notified bodies. The session provides valuable insights for all medical device manufacturers currently active in, or planning to enter, the European market.

• 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.

• 2026-03-02 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 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.