Our standards
Device manufacture
ISO 13485 (Medical devices)
Quality of manufacture is established by meeting benchmarked international standards, via the Quality Management Systems (QMS) standards stewarded by the International Standards Organisation (ISO).
ISO 13485 is the standard applicable to the manufacture of medical devices and is mandatory for all vaping products from 1 July 2025.
Liber's range of therapeutic vaping products has always been manufactured in an ISO 13485-certified facility.
Pharmaceutical GMP
Alongside the ISO QMS standards, pharmaceutical products are manufactured according to Good Manufacturing Practice (GMP).
GMP is a system of standards and procedures that ensures therapeutic goods are consistently produced and controlled to quality standards appropriate for their intended use and as required by regulatory authorities.
Liber’s manufacturing facility is certified as compliant with the US FDA pharmaceutical GMP requirements.
- This is not yet a mandatory requirement for therapeutic vaping products imported into Australia.
ISO 14971 (Risk Management for Medical Devices)
ISO 14971 is the international standard that provides a systematic process for identifying, evaluating, controlling, and monitoring risks associated with medical devices throughout their lifecycle to ensure patient and user safety.
Liber’s manufacturing facility has established a risk management system that complies with the requirements of ISO 14971 and is currently taking steps to formalise its ISO 14971 certification.
- ISO 14971 is not a mandatory requirement for therapeutic vaping goods in Australia.
Find your nearest stockist
Over 1,000 community pharmacies across Australia currently hold nicotine vaping products in-store.