We are now graded and approved as a medical device in South Africa
BIOCERTICA IS NOW SAHPRA APPROVED
BioCertica’s DNA Tests are now graded and approved as a medical device by the South African Health Products Regulatory Authority. 🥼
This means that all processing and analysis of genomic data handled by BioCertica are regulated according to the standards of the South African Health Products Regulatory Authority [SAHPRA].
SAHPRA approval includes:
- The analysis and processing of genomic data.
- Importing saliva kits from a supplier located outside the borders of South Africa.
- Storage and handling goods (DNA test kits) from customers and manufacturers.
- Packaging of bulk products and labeling thereof.
- Distribution of saliva kits within the borders of South Africa.
Our saliva kits are:
- ISO 13485:2016 certified (International Organization for Standardization)
- CE marked (In Vitro Diagnostic medical device Regulatory (EU) 2017/746)
See SAHPRA Certificate here.