Deficiencies in Medical Device Regulation in Zimbabwe

The regulatory framework for medical devices and in vitro diagnostics (IVDs) in Zimbabwe is plagued by several critical deficiencies that pose significant risks to public health and economic stability. This article highlights these deficiencies and proposes recommendations to address them.

Lack of Adverse Event Monitoring

Current Situation

There is no comprehensive system to monitor adverse events related to medical devices and IVDs, making it difficult to determine the true magnitude of these incidents. As a result, severe human and economic costs may go unnoticed and unmitigated.

Proposed Solution

Implement a comprehensive system for monitoring adverse events related to medical devices and IVDs. This would enable timely identification and mitigation of potential risks.

Inadequate Market Surveillance

Current Situation

Market surveillance and control mechanisms are inadequate, with no legal provisions for regulatory interventions at entry and exit points or market surveillance activities specific to medical devices and IVDs.

Proposed Solution

Introduce legislation mandating economic operators to record, investigate, and report incidents and take Field Safety Corrective Actions. Establish legal provisions for regulatory interventions at entry and exit points and market surveillance activities specific to medical devices and IVDs.

Lack of Supply Chain Transparency

Current Situation

The lack of regulations for licensing economic operators along the supply chain of medical devices and IVDs means that products are not traceable in the value chain.

Proposed Solution

Empower the MCAZ to issue licenses and oversee post-licensing changes, enhancing accountability and transparency in the supply chain.

Inadequate Laboratory Testing

Current Situation

While laboratory testing regulatory functions for condoms and gloves were found to be above average due to ISO 17025:2017 accreditation and assessments by external organizations, other medical devices and IVDs were not independently verified by laboratory testing based on the risk class of the medical device and IVD.

Proposed Solution

Enhance laboratory testing regulatory functions by implementing ISO accreditation and regular audits using ISO 15189:2012 and ISO 17025:2017 requirements.

Recommendations

1. Implement a comprehensive system for monitoring adverse events related to medical devices and IVDs.
2. Introduce legislation mandating economic operators to record, investigate, and report incidents and take Field Safety Corrective Actions.
3. Establish legal provisions for regulatory interventions at entry and exit points and market surveillance activities specific to medical devices and IVDs.
4. Empower the MCAZ to issue licenses and oversee post-licensing changes for economic operators along the supply chain of medical devices and IVDs.
5. Enhance laboratory testing regulatory functions by implementing ISO accreditation and regular audits using ISO 15189:2012 and ISO 17025:2017 requirements.

Conclusion

By addressing these deficiencies, Zimbabwe can ensure the safety and effectiveness of medical devices and IVDs, protect public health, and maintain economic stability.