AlloSource has evolved from a local tissue bank serving orthopedic surgeons in three states to an organization serving communities throughout the world. We are proud to help recipients inside and outside the United States Do More With Life.

Our current international communities include countries in:

• The Asian Pacific Rim
• The European Union
• North America
• Latin America
• South America

In addition to our regulatory compliance listed in the Resource Center, AlloSource maintains compliance to the following Quality System requirements per:

• Health Canada
  • SOR 98-282, Medical Device Regulations
  • SOR 2007-118, Safety of Human Cells, Tissues and Organs for Transplant
  • Z900.1 Cells, Tissues, and Organs for Transplantation: General Requirements
  • Z900.2.2 Tissues for Transplantation
• European Parliament and Council of the European Union
  • Directive 2006/17/EC, Technical Requirements for the Donation, Procurement, and Testing of Human Tissues and Cells (as amended by 2012/39/EU)
  • Directive 2006/86/EC, Traceability Requirements, Notification of Serious Adverse Reactions and Events, and Certain Technical Requirements for the Coding, Processing, Preservation, Storage and Distribution of Human Tissues and Cells
  • Directive 2004/23/EC, Standards of Quality and Safety for Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells
  • Directive (EU) 2015/566, The procedures for verifying the equivalent Standards of Quality and Safety of imported Tissues and Cells
  • HTA Directions 002/2018 – Directions promulgated for the purpose of securing adherence to the standards required under the European Tissues and Cells Directive (2004/23/EC) and the technical Directives 2006/17/EC (as amended by 2012/39/EU), 2006/86/EC (as amended by *(EU) 2015/565 and (EU) 2015/566)
    • *Note: Compliance with (EU) 2015/565 is the responsibility of the Importing Tissue Establishment (ITE) within the European Union.  It outlines the technical coding requirements (SEC) for the ITEs’ labeling of tissues for onward distribution into the European Union and not relevant to AlloSource as the Third Country Supplier (3CS)
• Korean law as prescribed in:
  • The SAFETY, MANAGEMENT, ETC OF HUMAN TISSUE ACT and ENFORCEMENT REGULATION OF SAFETY, MANAGEMENT, ETC OF HUMAN TISSUE ACT.
• Taiwan Food and Drug Administration regulations prescribed in:
  • Pharmaceutical Affairs Act
  • Pharmaceutical Good Manufacturing Practice Regulations

AlloSource complies with the appropriate regulations relative to product and/or establishment registration in all OUS markets where registration is required, and product is distributed.