08/04/2025
We’re thrilled to share that Laihe Biotech (brand name LYHER) has successfully obtained MDSAP (Medical Device Single Audit Program) certification! This significant milestone reflects our commitment to global medical device regulatory compliance and strengthens our position in international markets.
🔹 Why Does MDSAP Certification Matter?
The MDSAP certification allows us to meet the regulatory requirements of multiple countries—including the U.S. (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (PMDA), and Australia (TGA)—through a single audit. This streamlines our compliance processes and reinforces our ability to deliver high-quality, globally compliant medical devices.
🔹 What This Means for Our Customers & Partners:
âś… Faster market access in key regions
âś… Enhanced quality and compliance assurance
âś… Broader international reach
A huge thank you to our dedicated team for their hard work, and to our partners and customers for their continued trust and support. We remain committed to innovation and excellence, ensuring our medical devices meet the highest standards for safety and efficacy worldwide.
