• 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 09:14:49

The proposed PFDA guidelines establish requirements for maintaining importation and distribution records and for reporting product complaints, adverse events, and field safety corrective actions for medical devices to ensure traceability and facilitate appropriate regulatory action. This article outlines the specific responsibilities, strict reporting timelines, and record-keeping mandates designed to protect public health throughout the device lifecycle.

• 2026-04-01 08:37:41

The Malaysia Medical Device Authority (MDA) has implemented Circular Letter No. 1 Year 2026 that enforces a compulsory licensing for all medical device tenderers to possess a valid Establishment License. Compliance with Act 737 and related regulations is mandatory, with penalties for violations.

• 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 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.

• 2026-04-01 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.