• 2026-06-26 06:49:48

Qualtech will be exhibiting at BIO Asia–Taiwan 2026, taking place from 16–19 July 2026 at the Taipei Nangang Exhibition Center, Taiwan. Visit us at Booth N1007 to connect with our regulatory and business development specialists and discuss medical device registration, regulatory compliance and market access opportunities across Asia Pacific.

• 2026-06-26 06:31:01

The FDA's Electronic Medical Device Reporting (eMDR) program requires medical device manufacturers and importers to submit Medical Device Reports (MDRs) electronically for adverse events, malfunctions, and other reportable incidents. The eMDR system improves the efficiency, accuracy, and timeliness of post-market surveillance by enabling electronic submission, processing, and tracking of reports through FDA systems. Manufacturers should establish robust procedures to ensure compliance with eMDR requirements and maintain effective post-market monitoring of device safety and performance.

• 2026-06-26 05:27:53

Commission Implementing Regulation (EU) 2026/977 establishes uniform quality management and procedural requirements for notified bodies designated under MDR (EU) 2017/745 and IVDR (EU) 2017/746. The Regulation aims to harmonize conformity assessment practices, improve transparency and predictability, and ensure consistent treatment of manufacturers across the European Union.

• 2026-06-26 04:47:11

Australia's Unique Device Identification (UDI) system is moving from concept to reality, with the first mandatory compliance deadlines commencing in July 2026. Designed to strengthen patient safety, device traceability, and post-market surveillance, the phased implementation will introduce new obligations for both manufacturers and sponsors. This article explores how UDI works, key TGA compliance milestones, and what medical device companies should do to prepare.

• 2026-05-29 07:54:15

Join Qualtech's free webinar on June 18, 2026, to explore the latest regulatory developments and market access considerations for Australia and New Zealand. This session will provide practical insights into Australia TGA application pathways, key TGA updates in 2026, and the current regulatory framework in New Zealand, helping medical device manufacturers better prepare their ANZ market entry strategies.

• 2026-05-27 01:54:19

Effective May 6, 2026, Administrative Order No. 2025-0030 establishes a mandatory Post-Marketing Alert System (PMAS) for medical devices in the Philippines, aligning national policy with the ASEAN Medical Device Directive. The order requires manufacturers, traders, and distributors to maintain strict traceability records, report adverse events within 48 hours to 30 days, and implement Field Safety Corrective Actions to mitigate risks. A one-year transition period for industry compliance has officially commenced.

• 2026-05-22 02:22:56

As EU MDR expectations continue to intensify in 2026, manufacturers are facing greater scrutiny across technical documentation, clinical evidence, and lifecycle compliance. Qualtech's webinar recap highlights practical insights on MDR transition planning, Annex XVI obligations, notified body expectations, and key compliance priorities shaping EU market access strategies.

• 2026-04-28 01:22:14

In alignment with the latest regulatory guidance on SaMD and cybersecurity for network-connected devices, the framework for managing ancillary network infrastructure (such as VPN gateways) has been refined. This includes an extensive definition of responsible matrices, lifecycle security maintenance, and the implementation of proactive security controls to mitigate cyber risks.

• 2026-04-23 07:36:58

The webinar hosted by Qualtech in March takes a closer look at how medical device studies are conducted in the United States. Covering US FDA classification, IDE and IRB pathways, and study design, it connects regulatory frameworks with their practical application in study execution. This recap highlights key considerations shaping how studies are structured and managed in the US context.

• 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.