Meet CryoSave
CryoSave South Africa (Pty) Ltd (or “CryoSave SA”) has been cryopreserving cord blood stem cells for South African and international clients for more than 20 years. We are wholly owned by a secure financial group and have aligned our procedures with international quality standards and global best practices.
CryoSave SA is an independent Stem Cell Establishment, licensed by the South African National Department of Health, ISO 9001 and ISO 13485 approved, and internationally accredited by the Association for the Advancement of Blood and Biotherapies (AABB) for the collection, processing, cryopreservation, storage, and distribution of umbilical cord blood cells.
We have successfully processed and stored cord blood and tissue stem cells for more than 18,000 children.
Our Vision, Mission and Values
Vision
Our vision revolves around creating access to previously inaccessible medical opportunities to protect the future health of families through advanced predictive and regenerative medicine solutions.
Mission
Our goal is to provide affordable, life-saving technologies to families that want to make responsible and informed choices for their children. In this respect, CryoSave has invested in products and services that promote the adoption of regenerative medicine to improve their quality of life.
Values
Excellence. Quality. Affordability.
The CryoSave state-of-the-art laboratory ensures that the highest standards of excellence are continuously met. Our commitment to quality service and experience is at the core of our values.
The Laboratory
It operates under a comprehensive Quality Management System that is ISO 9001:2015 certified, and the facility maintains accreditation with the American Association of Blood Banks (AABB), ensuring compliance with globally recognized best practices in cellular therapy services.
CryoSave SA has been AABB-accredited since 2017. AABB is a global leader in transfusion medicine and cellular therapies, setting international standards for stem cell banking.
This accreditation ensures CryoSave SA meets rigorous guidelines for the collection, processing, storage, and distribution of stem cells. By adhering to these internationally recognized standards, we uphold the highest levels of safety and excellence in stem cell preservation.
CryoSave SA has been granted Authorised Institution Status by the Department of Health, South Africa.
We are authorised in terms of Regulations R183 of RG No. 9699 of 2 March 2012 to acquire, preserve, process, store and distribute stem cells. The regulations by which we are authorised are subject to the National Health Act No. 61 of 2003.
CryoSave South Africa is proud to be licensed by the South African Health Products Regulatory Authority (SAHPRA) to manufacture medical devices in accordance with Section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965).
This authorisation permits CryoSave SA to operate as a Manufacturer, Distributor, Importer, and Exporter of medical devices. The company ensures that all devices manufactured or distributed—regardless of their registration status—adhere to all applicable provisions of the Act.
CryoSave SA is also certified under ISO 13485:2016 and ISO 9001:2015 by KGS Certification (accredited by Standards Malaysia), affirming its commitment to international quality and safety standards in the processing and distribution of cord blood and tissue collection devices.
- ISO 13485:2016 certification confirms compliance with medical device quality management systems.
- ISO 9001:2015 certification ensures overall operational excellence and robust quality management practices.
These accreditations reflect CryoSave SA’s dedication to maintaining the highest standards of quality, traceability, and regulatory compliance in all aspects of its stem cell preservation services.