Zimbabwe medical device registration timeline

Planning steps and estimates; these are not regulator deadlines.

• No person may sell any condom unless the type and brand has been approved by the Authority, or sell any condom or glove unless the individual batch has been approved for distribution — the Condom Regulations 2005 (s.3 and s.9(1)) and the Gloves Regulations 2006 impose the two-step structure, and the applicant must be an importer, manufacturer or wholesaler.
• An application for approval of a type and brand of condom is made to the Authority in duplicate on Form M.C.Con.1, accompanied by the fee specified in s.14 and the number of samples the Authority requires; where the Authority approves the type and brand, the Director-General publishes notification of the approval in the Gazette. Gloves follow the same structure on Form M.C.G.1.
• Every batch must be separately approved: the applicant applies in duplicate on Form M.C.Con.2 (condoms) or Form M.C.G.2 (gloves), and the laboratory testing fees published by MCAZ apply per batch. The MCAZ laboratory tests against the standards in the Second Schedule to the Regulations.
• The annual retention fee for the right to sell a type or brand of condom must be paid on or before 1 April each year (s.14(3) of the Condom Regulations 2005 as inserted by Statutory Instrument 131 of 2014), and any package amendment carries its own prescribed fee. PROVENANCE CAVEAT: this attribution could not be re-verified this round, because both 2014 amendment instruments are published by MCAZ as image-only scans with no text layer and were not OCR'd, and the two sessions disagree about which instrument each number is — the registry's source key treats S.I. 131 of 2014 as the Condom (Amendment) Regulations (No. 4), while the round-209 Zimbabwe deliverable records S.I. 130 of 2014 as the Condom amendment and S.I. 131 of 2014 as the Gloves amendment. The claim is left standing and the conflict is reported rather than resolved.
• A licence is required to import, possess, sell, install or use a radiation source or irradiating device: s.14(1) of the Radiation Protection Act [Chapter 15:15] prohibits those activities except in accordance with prescribed requirements, s.15(1) prohibits administering ionizing radiation without a valid licence, and s.15(2) requires an application in the prescribed form with the prescribed fee.
• RPAZ's licensing service standards run only from a complete application — the Client Service Charter states that 'the service standard timelines are premised on the assumption that the client has met all regulatory requirements' — so the published periods are not achievable without the design, import and use applications being lodged correctly.
• RPAZ's activities requiring authorisation include medical diagnostic and interventional radiology (fixed and mobile x-ray machines, C-arms, fluoroscopy, mammography, bone densitometry, CT scanners, Gamma Knife and Cyber Knife), radiotherapy, nuclear medicine, dental and veterinary radiography, and service providers who supply, install or maintain radiation equipment — so a facility operating any of those holds the licence, and the equipment cannot be lawfully operated without it.
• Consignments of controlled goods arriving without a pre-shipment inspection certificate are subject to SAZ destination inspection: the goods must be controlled under SI 35:2024 and — except for motor vehicles — have a minimum FOB value of US$1,000.00, the application is lodged through the SAZ portal with the import documents, and the resulting e-Certificate of Conformity is what ZIMRA uses to clear the consignment.
• Equipment with a radio or telecommunications function requires POTRAZ type approval, applied for on the Authority's Equipment Type Approval Application Form with the equipment's technical specifications and test reports.