• 2026-09-21 02:42:09

The Department of Health (DH) of Hong Kong issued a letter regarding the updated regulatory requirements for the use of injectable and infusible product in licensed Private Healthcare Facilities (PHFs) which cover pharmaceutical products, human organ/human tissue product, and medical device. For medical devices, the DH has announced that all injectable and infusible medical devices used in licensed PHFs must be listed under the MDACS, effective 1 March 2027. This new requirement specifically includes injectable dermal fillers and injectable mucous membrane fillers.

• 2026-08-25 04:38:17

The Hong Kong Department of Health (DH), through its Medical Device Division (MDD), has established the "Novo Lane" under the Medical Device Administrative Control System (MDACS) to prioritize the processing of eligible innovative medical device listing applications. The initiative is intended to facilitate earlier access to innovative medical technologies while maintaining regulatory oversight of medical device safety and performance. As part of its regulatory approach, the MDD continues to monitor the safety and performance of listed medical devices after they are placed on the market.

• 2025-08-25 07:35:29

The NMPA has released new measures to foster innovation and strengthen regulation of high-end medical devices such as surgical robots, advanced imaging systems, AI medical devices, and innovative biomaterials. The policy emphasizes faster review pathways, improved standards, stronger lifecycle oversight, and enhanced international collaboration, aiming to accelerate market access and boost the global competitiveness of China's medical device industry.

• 2025-07-07 08:26:29

Join Qualtech's upcoming webinar, "Accelerating Innovation: Why Australia is the Ideal Partner for Your Next Clinical Trial" to explore how Australia's clinical trial environment supports faster, cost-effective, and globally recognized medical device development. The session will feature insights from Mobius Medical Pty Ltd, Qualtech's CRO trusted partner in Australia, and highlight key advantages including expedited approvals, R&D tax incentives, and data acceptance by major regulators such as the U.S. FDA.

• 2024-06-20 06:31:57

Australia is advancing in 3D-printed medical devices, demonstrating the technology's potential in healthcare. The market, valued at $36 million in 2022, is projected to reach $132 million by 2030, driven by applications in pre-operative planning, education, orthodontics, bioprinting, and customized prosthetics and implants. These innovations enhance patient outcomes and surgical accuracy, with significant growth expected in the Asia-Pacific region.

• 2024-04-03 09:16:23

The Philippine Food and Drug Administration (PFDA) released an advisory on March 06, 2024 announcing that COVID-19 Medicines and Devices will no longer be VAT-exempt, effective 01 January 2024. This is due to the expiration of the VAT exemption provision in the CREATE Act.

• 2023-07-24 10:42:16

Congratulations to our first PhD internship program candidate!! Graduating with PhD degree!!

• 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

• 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.

• 2022-06-30 11:51:47

Given the return and the increased popularity of in-person medical exhibitions, Qualtech has taken the opportunity to provide you with a sneak peek of the innovative medical device trends to be observed in ASEAN’s upcoming big medical exhibitions and fairs. This includes, among other fields, wearable technology, augmented reality for surgeon training and pre-operation planning, as well as virtual reality surgery with robotic and artificial intelligence assistance.