Achieve 80% cost reduction—from $25 to $5 per test—using the Mission® Cholesterol Meter, which delivers lab-accurate results in just 3 minutes. Boost patient follow-up by 60% while unlocking new revenue streams, and empower patients with immediate, accessible health insights. 

By 2025, medical device importers and distributors will face one of the most significant regulatory shifts in decades. The European Union's MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) deadlines are closing in, while the U.S.

QMSR will align FDA's medical device quality management system with ISO 13485:2016. It will be released by the end of this year and become effective one year later. This harmonization is expected to save medical device companies at least $439 million over the next decade.

With tightening EU regulations like MDR, IVDR, RoHS, and REACH, medical importers and distributors face growing compliance and supply chain risks. This article explores key impacts, actionable steps, and how working with Medasia ensures access to certified, cost-effective, and regulation-ready medical products.

As EU MDR/IVDR and environmental rules tighten, importers face growing compliance demands. This article highlights key 2024–2025 regulatory updates, their impact on importers, and offers practical guidance for compliant sourcing and market access.

The demand for home medical devices in China is surging, driven by an aging population and chronic disease management needs. From blood glucose monitors to AI-driven ventilators, this $42B market is redefining global healthcare accessibility.

Enter the eco-friendly solution: reusable pregnancy tests. These sustainable, innovative devices are not only shaping the way we test for pregnancy but are also harmonizing with the increasing global emphasis on environmental consciousness.

On 7^th November 2024, the ECHA (European Chemicals Agency) released the new Candidate List of SVHCs with the addition of one new substance. The current list of SVHCs now contains 242 substances.

Disposable digital pregnancy tests add to the plastic waste crisis through e-waste, non-recyclable materials, and toxic batteries. Emerging sustainable options like reusable and biodegradable tests offer greener, eco-friendly alternatives to reduce this environmental impact.

The IVDR transition period has been extended, allowing importers to continue selling products certified under the previous IVDD directive. This extension provides more time to comply with labeling, documentation, and certification requirements, minimizing non-compliance risks and maintaining market access.

Discover how AI, wearables, and cutting-edge diagnostics are driving innovation in the medical device industry in 2024, reshaping healthcare delivery while navigating regulatory and cybersecurity challenges.

The European Commission has released a Q&A document regarding the extension of the IVDR transition period, as well as an updated Q&A document on the extension of the MDR transition period, pursuant to Regulation 2024/1860, which was recently published.

The market demand for reusable digital ovulation tests is on the rise, driven by  growing consumer awareness around fertility tracking, interest in sustainable health products, and advancements in digital health technologies.

The application value of AI technology in family diagnosis is great, making diagnosis more accurate, convenient and efficient. By providing personalized health management solutions and empowering users with more health knowledge, AI is changing the way individuals approach health, leading to better health outcomes and more efficient healthcare systems.

In 2017, the FDA initiated MRAs with EU and UK, for human drugs. On May 30th, the FDA once again signed an MRA, with 16 EU countries, this time concerning veterinary drugs.

Discovering the significance of maintaining optimal kidney health is crucial for overall well-being. And now, keeping tabs on your kidneys has never been easier with the introduction of the Renal Function Meter. 

Before exploring their practical uses, it's essential to grasp the fundamental concept of hemoglobin meters.Hemoglobin meters are compact medical instruments meticulously engineered for gauging the hemoglobin concentration in an individual's blood.

Before delving into the portable hemoglobin meter market, it's important to understand the significance of hemoglobin in healthcare.