• 2026-07-28 03:07:42

Japan is advancing its surgical robotics sector, driven by an aging population and healthcare workforce shortages. Robotic-assisted surgery is expanding across urology, general surgery, and orthopedics, supported by growing public insurance coverage and rising institutional investment. Backed by a fast-growing market, Japan presents strategic opportunities for global medical device companies targeting the Asia-Pacific region.

• 2026-07-27 04:05:50

Qualtech's recent webinar provided practical insights into medical device market entry in Australia and New Zealand, covering Australia's ARTG inclusion process, post-market obligations, new UDI requirements, and New Zealand's WAND notification framework. The session also highlighted key regulatory updates and practical considerations for manufacturers planning expansion into the ANZ market.

• 2026-07-28 02:39:21

Starting July 2026, the Australian Therapeutic Goods Administration (TGA) will implement an overall increase in regulatory fees and annual charges for medical devices and in vitro diagnostic (IVD) devices. This article provides a detailed 2025 versus 2026 fee comparison, highlighting an upward adjustment of approximately 4.7% to 6.3% across various submission and maintenance categories. It also includes strategic insights from Qualtech on leveraging overseas approvals and managing hidden compliance costs to optimize long-term operational budgets and market access strategies

• 2026-07-27 03:54:16

HSA has recently stepped up its efforts to combat illegal and unregistered health products through both consumer advisories and enforcement activities. In its latest announcements, HSA warned against the online purchase of contact lenses and reported the removal of 959 illegal health product listings, with unregistered contact lenses accounting for over 82% of the cases. The authority also reminded sellers that non-compliance may result in enforcement actions, including product seizures, investigations, prosecution, fines and imprisonment. These developments highlight Singapore's continued focus on protecting public health and strengthening oversight of regulated medical devices.

• 2026-07-27 03:42:33

The Philippine FDA has issued a draft Circular proposing a comprehensive risk-based framework for post-approval variations of medical and health-related devices. Key proposed changes include the introduction of risk-based variation classifications, a dedicated variation pathway for medical device software (MDSW), single variation applications for eligible multiple product authorizations, updated submission procedures, and enhanced post-market responsibilities for Marketing Authorization Holders (MAHs) and retailers. The draft also provides guidance on timelines, fees, and regulatory enforcement to support a more standardized variation process.

• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

• 2026-07-27 03:03:43

The Medical Device Authority (MDA) of Malaysia has announced a commencement of the second phase of The Malaysia–China Joint Evaluation Pilot Programme upon successfulness of Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I) in 2025. Pilot phase 2 will run from 1 July 2026 to 30 September. The programme enables the MDA and China's National Medical Products Administration (NMPA) to conduct a collaborative joint evaluation of eligible medical device registration applications under the GHWP Common Evaluation Reliance Practice (CERP).

• 2026-07-27 02:48:38

The PMDA has issued a Q&A document providing practical guidance on the implementation of the Standards for Biological Raw Materials to ensure the quality and safety of pharmaceuticals, medical devices, and related products. The updated guidance addresses topics such as ensuring the reliability of donor screening and testing, the evaluation of prion clearance values, and considerations related to BSE risk status designations, thereby clarifying the latest operational approach to the Standards for Biological Raw Materials.

• 2026-07-27 02:32:02

The Hong Kong MDD has revised its Guidance Notes (GN-00), effective 13 May 2026. The update introduces Appendix 1, officially classifying injectable dermal and mucous membrane fillers as medical devices under MDACS. Manufacturers, LRPs, and consultants must evaluate this expansion due to immediate compliance and registration requirements.

• 2026-07-27 01:56:36

On June 1, 2026, the NMPA issued an announcement to further clarify the work related to registration and filing following the adjustment of the management classification category of medical device products. The announcement covers various scenarios, including initial registration, renewal registration, and change registration, and sets forth corresponding requirements for the production, distribution, and import of the products.