Medical Device Regulatory Requirements in Zimbabwe
| Regulatory Authority |
Medicines Control Authority of Zimbabwe (MCAZ) |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
Zimbabwe recognizes the need for a risk-based classification system for medical devices as part of its evolving regulatory framework, |
| Medical Device Regulations |
https://www.mcaz.co.zw/documents/medical-devices-docs/regulations-and-guidelines-docs
| Click Here
|
| In Vitro Diagnostics Regulations |
MCAZ is currently not regulating IVDs |
| Requirement of Authorized Representative |
Yes |
| Adverse Event Reporting Form |
Download |
| Additional Information |
At the moment, outside of medicines, the medical devices being regulated by MCAZ are gloves and male condoms. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025