Abstract
This study assesses the impact of medical devices and IVD medical device
regulations in South Africa following the initiation of the regulations by the
department of health through SAHPRA in December 2016. The objectives of the
study were as follows; to identify the perceptions of practitioners in the medical
devices industry regarding SAHPRA’s approach in the implementation of
regulations; investigating the relationship between the elements of SAHPRA’s
approach to regulation’s elements of compliance; and studying the impact of
the elements determined by the framework of regulatory compliance.
Questionnaires were distributed to quality practitioners in the Medical devices and
IVD’s industry. A total of 80 responses were targeted but in the course of the study a
response rate of 62.5% was obtained.
Cronbach’s Alpha coefficient was used to test the reliability of the study and
Exploratory Factor analysis was used the validity of the study. Statistical tools such as
means, standard deviations, correlation analysis, regression analysis, hypothesis
testing, and multiple regression analysis were used to analyse the quantitative data
for the research.
The results obtained indicate that the perceptions of practitioners towards SAHPRA’s
approach to regulatory compliance is a positive one. The results also indicate that
medical devices and IVD’s companies in South Africa are determined to meet the
requirements of the regulator. South Africa’s approach to regulate the industry is
similar to how regulations has been implemented in other parts of the world.