Table 3.

The Medicines Control Authority of Zimbabwe (MCAZ) – An example of sustainable, risk-based regulation

Due to a policy shift, in 1997, several Zimbabwean government entities, including MCAZ, were given the ability to run their operations by utilizing revenue generated through the provision of services. Since this change, MCAZ has performed several financial analyses and exercises to balance the need to cover the cost of service provision and the need to enable market entry for both domestic and international manufacturers. Equally important to obtaining the legal authority to independently run its operations was the work MCAZ undertook to develop the infrastructure and processes required to operationalize this new process: establishing the necessary financial procedures, developing standard operating procedures, and hiring and training an internal finance, accounting, and operations team. Because MCAZ are funded through generated fees, senior leadership also quickly recognized that a risk-based approach would be the only way to regulate effectively, balancing the need to sustain activities with the criticality of protecting patient safety. An example of this can be seen in how the organization has approached the regulation of medical devices. While MCAZ has had the mandate to regulate medical devices since its inception, the Authority decided to roll out this regulation based on risk, which dictated an initial focus on male condoms in 2005 and medical gloves in 2006 because of the prevalence of HIV/AIDS at the time. With the recent publication of WHO’s model guidelines on the regulation of medical devices [29], MCAZ is again displaying its responsiveness by starting to regulate the import and export of additional medical devices as part of an initial risk analysis.