MedInsight
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Decoding QMSR: FDA QMSR & ISO 13485 Harmony
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. -
What Medical Importers Must Do to Stay Ahead in 2025 Regulatory Landscape
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.
GarciaBartley -
Latest Compliance Insights for Medical Industry CE Certification & Environmental Regulations
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.
GarciaBartley -
Home Medical Devices in China: Market Trends, Key Players & Future Outlook (2025)
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.
GarciaBartley -
Reusable Pregnancy Tests: Eco-Friendly, Cost-Effective & Accurate Solutions for Modern Pregnancy Testing
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.Chris Berthe -
New update to Candidate List of Substances of Very High Concern (SVHCs)
On 7th 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.GarciaYbrahim
Company News
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Partnering for Success: How We Helped a European Client Gain Competitive Advantage
A European medical distributor improved healthcare delivery by introducing a portable hemoglobin meter to pharmacies, clinics, and hospitals — boosting diagnostic speed and patient care.
GarciaBartley -
Standing Up for Quality – Protecting Our Partners' Interests
When routine quality inspections uncovered non-conforming products at a partner factory, we refused to compromise. Discover how our team’s relentless advocacy secured a 12% compensation for our client, proving that true partnership means defending quality at every step – even when facing resistance.
GarciaBartley -
MedAsia at CMEF 2025: Co-Creating the Future of Healthcare with Global Partners
The 91st CMEF 2025, As a key industry player, MedAsia Healthcare showcased its three core business pillars—home diagnostic test strips, household health monitoring devices, and customized service plans—under the theme “Intelligent Global Healthcare, Co-Creating a Healthy Future”
GarciaBartley -
CMEF Spotlight: Join MedAsia in Exploring Cutting-Edge Medical Product
The 91st CMEF China International Medical Equipment Fair is set to commence from April 8th to 11th at the Shanghai National Convention and Exhibition Center. MedAsia Healthcare will showcase its intelligent digital solutions at the exhibition, and we cordially invite you to join us in exploring new possibilities in medical technology.
GarciaBartley -
Thank You, 2024—Looking Ahead to 2025 and the Arab Health Exhibition
As we close 2024, we’re grateful for the growth and partnerships that shaped our year.Looking ahead to 2025, we’re excited for new opportunities and continued collaboration.
We’ll be attending the Arab Health Exhibition in Dubai this January—let’s connect if you’re there!
GarciaBartley -
COP29: A Milestone in Global Climate Action and the Journey to Carbon Reduction
The 29th Conference of the Parties (COP29) concluded in Baku, Azerbaijan, marking a significant milestone in the global effort to combat climate change. This year's conference emphasized transparency, international cooperation, and financial commitments essential for global climate resilience.
GarciaYbrahim
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