SydPath’s TGA/GMP Licensing

SydPath is an Australian Approved Manufacturer under the Therapeutic Good Act 1989. The GMP licence authorises testing for virology screening, syphilis testing, NAT for HIV-1 and HCV and microbiological contamination testing for the manufacture of human tissues. These tests are mandated for tissue donors in accordance with the Therapeutic Goods Order 88 and for microbial contamination testing for product release. We are able to provide licensed testing for musculoskeletal, cardiovascular, ocular, human skin and human cell product tissue banks. To view our TGA license, please click here.

NATA Accreditation

SydPath is a fully accredited NATA registered facility with laboratories located at Darlinghurst, Moree & Narrabri. SydPath holds NATA accreditation in Anatomical Pathology, Chemical Pathology, Clinical Pharmacology & Toxicology, Haematology, Immunology & HIV Medicine, Genetics and Microbiology.
To view of Scope of Accreditation, please click here.
To view NATA Assessment Report, please click here.

Medicare Approval Certificate

SydPath holds the Medicare certificate of approval as an accredited pathology laboratory under the Health Insurance Act 1973.  This is part of our ongoing ISO 15189 accreditation (Medical laboratories — Requirements for quality and competence). To view our certificate, please click here.

External Quality Assurance (EQAs)

SydPath routinely participates in a range of External Quality Assurance Schemes as part of its commitment to maintaining the accuracy of laboratory testing.

Import Permits

Current permit to import quarantine material into SydPath can be found at:

Import Certificate for Diagnostic Kits

Import Certificate for Genetic Material and other Biologicals

Collection Centres

SydPath collection centres are fully accredited with the Health Insurance Commission. All our collection centres are staffed with highly trained and experienced pathology collectors. Our pathology collectors undergo extensive training prior to being placed in one of our centres. SydPath have a number of collection centres located through out NSW. For a list of collection centre locations, please click here.