July 28, 2025

Koru Pharma is proud to announce a significant milestone in its commitment to safety, quality, and regulatory compliance. Following a comprehensive official audit, we have successfully obtained Medical Device Single Audit Program (MDSAP) certification, along with full compliance with ISO 13485 for our Quality Management System (QMS) and medical devices for dermal filler.

What is MDSAP?

The MDSAP certification is a globally recognised quality system certification that consolidates quality audits required for market authorisation in multiple jurisdictions. While it does not directly grant product approval, it plays a vital role in the regulatory process, ensuring manufacturers meet highest international standards.

What does this mean for our partners?

MDSAP certification simplifies and speeds up regulatory processes for our distributors by allowing one audit to be recognised by multiple international authorities. This significantly reduces delays, ensures consistent quality standards, and supports faster market entry in key countries.

MDSAP Certification Secured – Empowering Distributors with Global Compliance

This achievement confirms Koru Pharma’s commitment to maintaining the highest quality standards across every stage of production. It reflects our dedication to continuous improvement, ensuring that our partners and patients can always trust in the safety and reliability of our products.