• 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.

• 2026-01-30 04:29:37

The European Union has established post-market surveillance (PMS) requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) to ensure the continuous safety and performance of medical devices and IVDs placed on the market. This framework emphasizes proactive monitoring, data collection, and lifecycle-based compliance to promptly identify and address potential risks.

• 2025-12-26 04:30:43

The Indonesian medical aesthetics market is projected to grow significantly, reaching is it USD 450.23 million by 2028, driven by increasing awareness and demand for cosmetic procedures. Key market drivers include advanced cosmetic technologies, a growing middle-class population, and supportive government policies. However, challenges such as regulatory constraints and high procedural costs remain.

• 2025-10-27 06:53:05

The Asia Pacific aesthetic devices market will grow from USD 5.0 billion in 2024 to USD 11.5 billion by 2032, driven by minimally invasive treatments, innovation, and medical tourism. Emerging trends in preventive care, home-use devices, and male aesthetics create diverse opportunities across China, Japan, South Korea, Thailand, and Vietnam. Manufacturers that adapt to local demand and regulations will capture this expanding market.

• 2025-09-24 07:20:49

The FDA has issued draft guidance on marketing submissions for AI-enabled device software functions (AI-DSFs), with a focus on using a predetermined change control plan (PCCP). A PCCP allows manufacturers to plan and manage software changes in a predictable and controlled way, making regulatory review smoother and device performance more reliable.

• 2025-07-10 09:00:31

Vietnam is experiencing a significant rise in cardiovascular disease (CVD). This article highlights the alarming rate at which heart diseases are affecting the population and its substantial impact on the Vietnamese health. The growing burden of CVD is also creating a significant market for cardiac medical instruments to prevent, detect and treat CVD in Vietnam.

• 2025-03-26 06:09:21

While the Philippines' ambitious Universal Health Care Act and substantial government investment are creating a rapidly expanding market for medical devices, the nation's overwhelming reliance on imports starkly contrasts with its limited domestic manufacturing capabilities. This situation, however, creates an opening for overseas manufacturers to provide the needed medical devices and take advantage of the increasing market.

• 2025-03-10 02:22:15

Join Qualtech's webinar on March 26, 2025, for key insights into Australia's medical device market and TGA regulations. Learn about the registration process, Sponsor responsibilities, post-market requirements, and get answers to common questions. Register now here to secure your spot!

• 2025-02-21 05:20:11

Japan's contact lens market is growing rapidly, driven by high myopia rates, aesthetic preferences, and strong domestic demand. A robust network of 2,340+ ophthalmology departments and qualified eye care professionals support the growth of the contact lens market in Japan. Daily disposables dominate this market, supported by a well-established ophthalmology infrastructure. Qualtech offers valuable insights of the Japanese contact lens market in this article, revealing a promising opportunity for foreign manufacturers.