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.