Examining the Efficiency of Medical Device Registration in South Africa Since the Establishment of the South African Health Products Regulatory Authority

Abstract

Background: With the Medicine and Related Substances Amendment Act 14 of 2015 implemented as law, it has amounted to significant changes for Medical Devices regulations in South Africa. More specifically, this meant the establishment of the South African Health Products Regulatory Authority (SAHPRA). These changes were significant milestones for the health sector in South Africa and allowed for a dedicated regulatory framework for medical devices. Whilst the South African government has established SAHPRA and provided for deliberate attempts to improve on the medical device regulation in the country, areas for medical device regulation improvement remain. Aim: To assess the efficiency of the medical device registration process in South Africa by understanding manufacturer awareness of the regulatory framework and exploring operational challenges faced during the registration process. Methods: A quantitative, exploratory research design has been selected for this research using a self-administered questionnaire. The research targeted medical device manufacturers which may or not also be licensed importers and distributers, within South Africa and with a SAHPRA establishment license. There are 708 registered medical device manufactures but only 354 had contactable information made public, and therefore, we expected 185 respondents. Response rate though was very low for this research study and only 50 responses were received. Results: As the objective of this research was to assess the efficiency of the medical device registration process in South Africa, through determining knowledge and perceptions of manufacturers and challenges they face, the results of this study indicated that majority of participants have been employed within the medical device industry between ten to fifteen years (n=15;33.3 %), enabling them to make a comprehensive comparison of the regulatory framework for medical devices in South Africa from a pre- and post-SAHPRA era. Through the survey responses received, medical device manufacturers acknowledge that an established framework exists with respective guidelines available for reference throughout the registration and licensing process. Gaps and challenges still exist ranging from lack of resources to delays in registration, contributed to by various factors. vii Conclusion: The comparative analysis of the perceptions and knowledge of the medical device regulatory framework in South Africa and the challenges faced by medical device manufacturers, which were the focus of the study, described in this report demonstrates a significant level of understanding and growth in the regulatory evolution in the country since the inception of SAHPRA. From the study, majority (n=39; 86.6%) are familiar with the Medical Device Regulation in South Africa and of that, n=34;75.5% acknowledge that guidelines are available to ensure that correct processes are followed when registering medical devices. The adoption of and alliance with global regulatory requirements has allowed SAHPRA to control quality and safety of medical devices on the market and to somewhat close gaps with global regulatory authorities. Medical device manufacturers in South Africa are optimistic that with the growing industry and a clear indication of problem areas within the framework and regulatory organisation, positive strides will be made. To build a regulatory climate that fosters innovation and growth while guaranteeing patient safety, medical device manufactures emphasize the need for SAHPRA to address challenges and work closely with all stakeholders.