Zimbabwe
| Regulatory Agency | Medicines Control Authority of Zimbabwe (MCAZ) – the national regulator responsible for implementation and enforcement. | ||||||||||
| Regulation Name | Guidelines for Implementing Traceability of Medical Products in Zimbabwe (MCAZ/LED/GL-22) | ||||||||||
| Compliance Dates |
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| Applies to | All medical products that are manufactured, imported, exported, advertised, sold, distributed, or used in Zimbabwe, unless explicitly exempted Exemptions include:
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| Barcode Symbology | GS1 DataMatrix (2D barcode) for unique identifier encoding |
| Barcode Content |
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| Serial Number Randomization | Serial numbers can be generated by deterministic or non-deterministic algorithms, per GS1 rules. |
| Serial Number Reuse | Not addressed specifically beyond GS1 specifications; reuse of SSCC at tertiary level allowed per GS1 rules. |
| Human Readable Expiry Date Format | Expiry date encoded per GS1 (YYMMDD); human-readable display required to match encoded data. |
| Barcode Data Encoding | GS1 General Specifications |
| Product Code Notes | GTIN must be assigned consistent with GS1 rules. If additional data beyond required elements is needed, MCAZ approval is required. |
| Free Samples must be marked? | Not explicitly stated, but all products within scope must carry traceability features. |
| Barcode Symbology | GS1 DataMatrix or GS1-128 may be used for tertiary packaging | |
| Barcode Contents | GTIN + Batch/Lot + Expiry Date (no serial required at tertiary level unless designated as trade item). | |
| Parent-Child Mapping Aggregation Capture? | Yes. establishes linkage between a unique parent item and its children within higher packaging levels | |
| Send Unit Data to Government Repository? | Yes — manufacturers and stakeholders must share unique identifier and traceability data with MCAZ. | |
| Send Unit Data to Third-Party Repository? | Not explicitly required | |
| Send Unit Data to Trading Partner? | Electronic capture and sharing is mandated, though primary focus is MCAZ | |
| Send Aggregation Data to Government Repository? | Yes | |
| Send Aggregation Data to Third-Party Repository? | Not specified beyond primary MCAZ reporting | |
| Send Aggregation Data to Trading Partner? | Aggregation capture is required; electronic sharing with supply chain stakeholders is part of traceability. | |
| Who Offers Data Repository for Authentication? | The MCAZ acts as the central repository for traceability data; private third-party repositories are not specified as mandatory in the guideline. |
| Manufacturers Must Register Shipments in Repository? | Yes; product unique identifier data must be submitted to MCAZ before market placement |
| Downstream Trading Partners Must Authenticate on Receipt? | Stakeholders must electronically capture traceability events (including receipt). |
| Downstream Trading Partners Must Authenticate on Shipment? | Same — share traceability events electronically per guideline. |
| Manufacturer Activity Reported? | Yes |
| Downstream Trading Partner Activity Reported? | Yes |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
