One Audit, Five Markets: AICHEK Achieves Prestigious MDSAP Certification

We are thrilled to announce a pivotal milestone in AICHEK’s commitment to global quality and regulatory excellence: we have officially been awarded the prestigious Medical Device Single Audit Program (MDSAP) certification!

This achievement is more than just a new certificate on the wall; it is a HUGE step forward in our mission to bring world-class, reliable medical products to patients and partners worldwide.

What is MDSAP, and Why is It a Game-Changer?

MDSAP, or the Medical Device Single Audit Program, is a collaborative initiative developed by international medical device regulators to conduct a single, unified audit of a medical device manufacturer’s Quality Management System (QMS).

In simpler terms, one comprehensive audit replaces the need for separate inspections by regulatory bodies in five major global markets. The certification confirms that our QMS not only meets the foundational ISO 13485:2016 standard but also satisfies the highly specific and stringent regulatory requirements of:

• 🇺🇸 United States (FDA)

• 🇨🇦 Canada (Health Canada)

• 🇧🇷 Brazil (ANVISA)

• 🇦🇺 Australia (TGA)

• 🇯🇵 Japan (MHLW/PMDA)

The Direct Benefits for Our Partners

For our partners, distributors, and the wider healthcare community, this certification delivers tangible advantages that streamline the journey from manufacturing to market:

1. The Ultimate "Global Passport"

MDSAP acts as a critical global passport. By having one universally accepted audit report, we can significantly accelerate product registration, regulatory submissions, and subsequent market access across all five participating countries. This rapid access is crucial in bringing life-saving and diagnostic medical devices to global communities faster.

2. Streamlined Compliance and Reduced Burden

The principle of "Five markets, one audit" drastically reduces the regulatory burden. Instead of preparing for and undergoing multiple national inspections, our unified system allows for efficient compliance. This saves significant time and resources—not just for AICHEK, but also for our partners who rely on our robust and certified QMS for their own regulatory filings.

Confirming World-Class Capabilities

Achieving the MDSAP certification confirms the international compliance and advanced capabilities embedded across all levels of our organization. This includes:

• Product Design and Development: Ensuring safety and efficacy are engineered into every product from the start.

• Manufacturing Excellence: Maintaining the highest standards of quality and control on the production floor.

• Post-Market Surveillance: Demonstrating a rigorous system for monitoring product performance and managing risk after launch.

At AICHEK, our commitment to quality is non-negotiable. The MDSAP certification validates our efforts and underscores our focus on delivering reliable, compliant, and world-class medical products.

We look forward to leveraging this powerful Global Passport to further enhance our service to you and to make a greater contribution to global healthcare.