June 23, 2017

India Changes Acceptance Criteria for IVD Test Kits

India’s Ministry of Health and Family Welfare has revised the acceptance criteria for in vitro diagnostic devices to detect HIV, HBsAg and HCV.

The change was recommended by the Technical Committee following quality control and lot release testing. The June 13 order recommends the following criteria for acceptance of sensitivity and specificity for test kits: anti HIV ½ and or HIV-1 p24Ag must test sensitivity at 100 percent and specificity at 98 percent or greater; the HBsAg test must test sensitivity at 100 percent and 98 percent or greater for specificity; and the Anti-HCV test must test sensitivity at 100 percent and specificity at 98 percent or greater. The rapid test kit should test sensitivity at 99 percent.

South Africa Calls for Nominations for New Regulatory Authority

The South African Health Products Regulatory Authority is asking the public to submit nominations for the board of the new authority.

SAHPRA positions to be filled include up to 10 people with expertise in the field of medicine, medical devices, in vitro diagnostics, clinical trials, good manufacturing practices, public health and epidemiology. The agency is also looking for additional staff who have knowledge of the law, good governance, finances, information technology and human resource management.

Employees of national, provincial and local government agencies are not entitled to additional remuneration if they serve on the SAHPRA board. Nomination forms may be obtained from the Department of Health website at http://www.doh.gov.za/.