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MCAZ · structured requirements

🇿🇼 Zimbabwe medical device regulatory data

Explore the medical device requirements currently available for Zimbabwe, organized by topic and linked to official sources.

32 facts23 dimensions13 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Advertising control under the Act is defined in relation to medicines; no device advertising rule exists

advertising.controls-are-medicines-only
Fact-level verified
Statement

The Act's advertising controls are defined in relation to medicines: 'advertisement', in relation to any medicine, means written, pictorial, visual or other descriptive matter, or a verbal statement or reference, appearing in any publication, on television or film, distributed to members of the public, or otherwise brought to the notice of members of the public, intended to promote the sale of that medicine, and section 40 governs the advertisement of medicines. MCAZ's Strategic Plan accordingly lists 'Control of promotion and advertising of medicines' among the Authority's overall functions. The section 38(1)(b) regulation power could in principle be used to restrict the advertising of a controlled device, but no such restriction has been made in either the Condom or the Glove Regulations, and no device advertising guideline, approval or fee exists.

Conditions
  • In the absence of a device advertising rule, practical control over device promotion is indirect - through the prohibition on selling an unapproved type or brand, and through the Act's offence provisions for contravening section 38 regulations.
  • MCAZ's advertising fee heads (advertising to the general public, promotional fees to health-care professionals, exhibition fees) are set in its medicines fee schedule and contain no device item.

Verbatim (Act s.2): '"advertisement", in relation to any medicine, means any written, pictorial, visual or other descriptive matter or verbal statement or reference- (a) appearing in any newspaper or other publication; or (b) appearing on any television or cinematograph film; or (c) distributed to members of the public; or (d) brought to the notice of members of the public in any manner whatsoever; which is intended to promote the sale of that medicine.' MCAZ Strategic Plan 2026-2030 Overall Functions: 'h. Control of promotion and advertising of medicines.'

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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No stated validity period; a retention fee of US$100 falls due on or before 1 April each year

validity.annual-retention-1-april-no-stated-term
Fact-level verified
Statement

The device regulations state no validity period for an approval of a type and brand of condom or a type of glove. What they impose is an annual retention obligation: the fee payable for the retention of the right to sell a type or brand of condom, or of a type or brand of glove, is US$100, payable on or before 1 April annually. Batch approvals are separately time-bounded - for condoms, where the Authority approves a batch, 'such batch may be sold for such period as determined by the Authority'. MCAZ publishes registers of approved and retained condoms and gloves, which is how the current status of an approval is made public.

Conditions
  • Because there is no stated term, an approval appears to continue so long as the annual retention fee is paid and the batch release requirements continue to be met.
  • There is no renewal application procedure in the device instruments; the mechanism is a retention fee rather than a renewal assessment.

Verbatim (SI 131 of 2014, new s.14(3)): 'The fee payable for the retention of the right to sell a type or brand of condom shall be as prescribed in the Third Schedule which shall be payable on or before the 1st April, annually.' Verbatim (Condom Regulations s.9(3)): 'Where the Authority approves a batch of condoms, such batch may be sold for such period as determined by the Authority.' SI 130 of 2014 inserts the equivalent glove retention provision at s.13(3). The instruments state no validity term for the type or brand approval itself.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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MCAZ is the competent authority, but its registration mandate under the Act is medicines; devices need a separate ministerial regulation

authority.mcaz-competent-authority-medicines-not-devices
Fact-level verified
Statement

The Medicines Control Authority of Zimbabwe (MCAZ) is the statutory regulator established by the Medicines and Allied Substances Control Act [Chapter 15:03]. The Act's registration machinery is a Medicines Register and a registration regime for medicines: Part IV is headed 'Registration of Medicines', and the Act's long title confers functions on the Authority 'in relation to the registration of medicines'. Medical devices are not a registrable category in their own right. Devices can only be brought under control if the Minister, after consulting the Authority, makes regulations under section 38(1)(b) covering 'any device or article' used in the diagnosis or treatment of a physical or mental state in man. Two such instruments exist - the Condom Regulations (SI 183 of 2005) and the Gloves Regulations (SI 1 of 2006) - and MCAZ's own 2026-2030 Strategic Plan records the Medical Devices Unit's functions as the regulation and quality conformity assessment of male condoms and medical gloves only, with a proposed Medical Products and Allied Substances Control Bill needed to 'expand scope to medical devices'.

Conditions
  • Condoms and gloves are the only device classes brought under control by regulation; every other device class is outside MCAZ's registration regime.
  • A draft Medical Products and Allied Substances Control Bill, listed in the Strategic Plan as 'proposed', would expand scope to medical devices; it is not yet the operative law.

Verbatim (long title): 'AN ACT to establish a Medicines Control Authority of Zimbabwe and to confer functions on such Authority in relation to the registration of medicines; to provide for the Zimbabwe Regional Medicines Control Laboratory and for its functions; to provide for the appointment of a Director-General of the Authority and for the keeping of a Medicines Register; to provide for certain prohibitions, controls and restrictions relating to medicines and other substances; and to provide for matters connected with or incidental to the foregoing.' Section 38(1): 'The Minister may, after consultation with the Authority, by regulation, prohibit, control or restrict- ... (b) the manufacture, possession, sale or use of- ... (iii) any device or article which is used, or is manufactured, sold or represented as suitable for use, in the diagnosis or treatment of any physical or mental state in man if, in the opinion of the Authority, such regulations are desirable in the public interest.' Part IV heading: 'REGISTRATION OF MEDICINES'. Strategic Plan 2026-2030, Medical Devices Unit: 'Regulation and Quality Conformity Assessment of male condoms in accordance with SI 183 of 2005; Regulation and Quality Conformity Assessment of medical gloves in accordance with SI 1 of 2006; Factory inspections (cGMP) of condom and glove manufacturing facilities.'

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Any alteration to the particulars supplied must be notified without delay; a package amendment costs US$50

change.notify-alterations-and-package-amendment-fee
Fact-level verified
Statement

Every person must inform the Authority without delay of any alteration from the information or particulars furnished in applying for approval of a type and brand of condom, and the same duty applies to a type of glove. The 2014 amendments add a package amendment fee of US$50 in each instrument, which is the published change-control charge for a packaging change. Beyond the notification duty and the package amendment fee, the device instruments set out no variation categories, no prior-approval requirement for changes and no substantial-change test.

Conditions
  • MCAZ's separate variation and amendment machinery (fee schedule items for variations, re-registration and amendments) is built for registered medicines.

Verbatim (Condom Regulations s.12): 'Every person shall without delay inform the Authority of any alteration from the information or particulars furnished by him in applying for approval for a type and brand of condom in terms of section 5.' SI 131 of 2014 s.3 inserts into the Third Schedule: 'Fee payable for package amendment . . . 50,00'. SI 130 of 2014 does the same for gloves, and Gloves Regulations s.11 contains the equivalent notification duty.

Classification rules

What local class follows from which rules and decisive product facts?

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Gloves are regulated by 'type': the regulations define five glove categories (single-use medical, sterile surgical, examination/procedure, seamed/welded, any other glove determined by the Authority) and prohibit sale of any glove not of an approved type (SI 1 of 2006, ss. 2-4)

classification.glove-categories-and-type-approval
Fact-level verified

The Gloves Regulations apply to gloves used for any medical purpose and define 'glove' as (a) a single-use medical glove protecting against cross-contamination, (b) a sterile anatomically shaped surgical glove for invasive surgery, (c) an examination or procedure glove, (d) a seamed or welded glove made by bonding flat films, or (e) any other glove determined by the Authority; no glove may be sold unless it is of a type approved by the Authority, which may attach conditions to the approval. There is no risk-class axis; the regulatory unit is the approved type (per brand).

Conditions
  • Applies to gloves only; condoms are approved per 'type and brand' under SI 183 of 2005 s.3, and no other device category has a classification instrument in Zimbabwe.

Effective from 2006-01-01

Typographical error 'thump' is in the source. Section 6 requires Gazette notification of each approved type.

No risk classification system; devices are approved by 'type and brand' for condoms and 'type' for gloves

classification.no-risk-classes-type-and-brand-only
Fact-level verified
Statement

Zimbabwe operates no risk-based classification system for medical devices. There is no Class A-D scale, no classification rules and no classification guideline. The only differentiation in the device instruments is commercial and descriptive: condoms are approved per 'type and brand' (the MCAZ FAQ explains that for condoms 'a type of condom refers to variation for example, dotted, ribbed strawberry flavor, extra-large etc.'), and gloves are approved per 'type', described by finishing dressing (powdered, powder free), use (examination, surgical) and material of construction (nitrile, latex, vinyl). Registration is therefore done per brand per type, with separate samples and forms for each. Any risk differentiation is instead achieved through the Second Schedule standards applicable to the class of device, not through a classification rule.

Conditions
  • Because there is no classification scheme, there is no class-dependent dossier depth, no class-based conformity assessment route and no reclassification procedure.
  • The MCAZ Strategic Plan 2026-2030 states that the proposed Medical Products and Allied Substances Control Bill would bring about an 'expanded scope to medical devices and allied substances', which is where a classification system would be expected to arrive.

The complete MCAZ 'Medical Devices documents - Regulations and Guidelines' listing contains exactly four items: 'Medicines and Allied Substances Control (Gloves) (Amendment) Regulations, SI 131 of 2014 (No.4)'; 'Medicines and Allied Substances Control (Condom) (Amendment) Regulations, SI 130 of 2014 (No.4)'; 'Condom Regualtions'; 'Glove Regulations'. No classification guideline, registration guideline or device fee schedule is listed. The MCAZ FAQ adds: 'Registration of gloves is done per brand per type'; 'Registration of condoms is done per brand per type'; glove type is described by 'finishing dressing (powdered, powder free) use (examination, surgical)' and 'material of construction (nitrile, latex, vinyl)'; 'A type of condom refers to variation for example, dotted, ribbed strawberry flavor, extra-large etc.'

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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A condom may not be approved unless it meets the Second Schedule performance standards, verified by laboratory testing

clinical.performance-standards-precondition-for-condom-approval
Fact-level verified

A condom is defined in Zimbabwean law as a medical device intended to be worn on the penis during sexual activity for the purposes of contraception and to prevent the spread of sexually transmitted infections. MCAZ may not approve a condom unless it meets the standards set out in the Second Schedule to the Condom Regulations, or as specified by the Authority in guidelines from time to time. The Second Schedule's performance requirements are burst volume and burst pressure before and after oven conditioning, freedom from holes, and visible defects, in each case verified by laboratory testing against ISO 2859-1 sampling plans with stated acceptance quality limits (AQL 1.5 for burst volume and burst pressure, AQL 0.25 for freedom from holes, AQL 0.4 and AQL 2.5 for visible defects). Approval is granted for a type and brand, and each batch must separately be approved for distribution before it may be sold.

Conditions
  • This is the device-specific performance-evidence route: Zimbabwe's device instruments are the Condom Regulations 2005 (SI 183 of 2005) and the Gloves Regulations 2006 (SI 1 of 2006), not a general medical-device regulation.
  • The regulations are made under section 74 and after consultation with the Authority under section 38 of MASCA.
  • Costs of testing for approval are borne by the importer, manufacturer or wholesaler (section 14(2)).

Statutory Instrument 183 of 2005, retrieved 2026-09-16 over direct HTTPS (HTTP 200, application/pdf, 152990 bytes). The Second Schedule is laid out as a table; the rows quoted below are transcribed in table order (requirement, section reference, sampling, verification).

MCAZ guidance describes prior trial authorisation for medical products; the Act uses the narrower term medicines

clinical.prior-written-authorisation-before-a-clinical-trial
Fact-level verified

MCAZ's clinical trial guideline (MCAZ/PVCT/GL-04 Rev 2, August 2024) describes MASCA as defining a clinical trial as a systematic study done in human beings or animals in order to establish the efficacy of, or to discover or verify the effects or adverse reactions of, medicines or medical products, and as requiring the Authority's prior written authorisation, granted with the approval of the Secretary for Health and Child Care, before any clinical trial of a medical product. The consolidated Act itself is narrower in its wording: s.2 defines 'clinical trial' by reference to 'medicines' and s.16(1) prohibits conducting a clinical trial 'of any medicine' without the Authority's prior written authorization granted with the approval of the Secretary. Review and approval is expected to take up to 60 working days from receipt of a complete application package by MCAZ's Pharmacovigilance and Clinical Trials Division, excluding the time the applicant spends answering queries; for clinical trials for emergency preparedness the expedited timeline may be reduced to 15-30 working days, subject to early submission of a complete application. Applications are submitted through the Electronic Clinical Trials Registry System at https://e-ctr.mcaz.co.zw/, and after approval the principal investigator reports adverse events, AEFIs and serious adverse events through the Electronic Pharmacovigilance system at https://e-pv.mcaz.co.zw/.

Conditions
  • Applicant-facing framing of the trial-scope test is written in terms of 'medicinal products': §1.0 asks whether the study involves medicinal products and whether the objective is to study their therapeutic, diagnostic or preventive effect. The words 'medicines or medical products' are the guideline's rendering in §3.0; the Act's own s.2 and s.16(1) say 'medicines'/'medicine'.
  • The 60-working-day figure is an expectation ('is expected to take up to'), not a statutory clock.
  • The MASCA prohibition and offence for conducting a trial without authorisation is s.16(1)-(2) in Part III (Clinical Trials, ss.16-25); s.17(1), which the guideline cites, is the application provision.

Effective from 2024-08-01

MCAZ/PVCT/GL-04 Rev 2, August 2024, retrieved 2026-09-16 over direct HTTPS (HTTP 200, application/pdf, 1949526 bytes). The guideline quotes the Act's own definitional sentence, which is the wording relied on; the applicant-facing questionnaire in §1.0 is narrower because it is drafted for medicinal-product sponsors.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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A condom is defined as a medical device; approval is per type and brand

scope.condom-is-a-medical-device
Fact-level verified
Statement

The Condom Regulations define a 'condom' as 'a medical device which is intended to be worn on the penis during sexual activity for purposes of contraception and to prevent the spread of sexually transmitted infections'. A person may not sell any condom unless it is of a type and brand approved by the Authority, and the Authority may fix any conditions it considers necessary or desirable when approving a type and brand.

Effective from 2005-01-01

Verbatim (s.2): '"condom" means a medical device which is intended to be worn on the penis during sexual activity for purposes of contraception and to prevent the spread of sexually transmitted infections.' Verbatim (s.3(1)): 'No person shall sell any condoms unless such condom is of a type and brand which has been approved by the Authority.' This is the only place in Zimbabwe's device instruments where the term 'medical device' is defined; the Act itself does not define it.

Gloves are defined by medical use, with five categories including examination and surgical gloves

scope.glove-definition-and-medical-purpose
Fact-level verified
Statement

The Gloves Regulations define a 'glove' as a medical glove for single use intended to protect the user from cross-contamination; or a sterile, anatomically shaped surgical glove intended for invasive surgery; or an examination or procedure glove intended for medical examinations, diagnostic and therapeutic procedures and handling contaminated medical materials; or a seamed or welded medical glove; or any other glove determined by the Authority. The regulations apply to gloves used or intended for use for any medical purposes. A person may not sell any gloves unless the glove is of a type approved by the Authority.

Effective from 2006-01-01

Verbatim (s.2): '"glove" means - (a) a medical glove for single use which is intended for use in the medical field to protect the user from cross-contamination; or (b) a surgical glove which is sterile, anatomically shaped medical glove with the thump positioned towards the palmar surface of the index finger rather than lying flat, and intended for use in invasive surgery; or (c) an examination or procedure glove which may or may not be anatomically shaped, intended for conducting medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical materials; or (d) a seamed or welded medical glove manufactured by welding or otherwise bonding together flat films of material; or (e) any other glove as determined by the Authority.' Section 3: 'These regulations shall apply to gloves used or intended for use for any medical purposes.' Section 4(1): 'No person shall sell any gloves unless such glove is of a type which has been approved by the Authority.' Non-medical gloves are outside the regulations because section 3 limits application to gloves used or intended for use for any medical purposes.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Application content: applicant particulars, manufacturer identity, packaging, specifications, sample count and test undertaking

dossier.application-particulars-and-samples
Fact-level verified
Statement

The device application is a short administrative and technical form rather than a CTD dossier. Form M.C.Con.1 requires the applicant's particulars and registered office, the name under which business is conducted, the manufacturer's name and physical address, whether alternative sources of manufacture exist, the importer's and distributor's names and addresses, the trade mark and distinguishing marks, how the condom is packed and how it will be offered for sale to importers, wholesalers, retailers and the public, the type of sealing for individual packs, the specifications of the condoms including shelf life, a summary of the methods used to ensure compliance with specifications, an explanation of all packaging codes, and the number of samples submitted. The form must be submitted in duplicate with the application fee and the required samples, and an undertaking to pay testing costs with a deposit. Form M.C.G.1 for gloves is structured the same way.

Conditions
  • Sample quantities are fixed by practice rather than by regulation: MCAZ's FAQ states 500 pieces of gloves (5 boxes of the same batch number) and 1,400 pieces of condoms in consumer packages intended for the market.
  • The First Schedule form notes that samples and printed matter must be forwarded by post or other means with carriage, customs duty and clearance paid and effected by the applicant in all instances.

Verbatim (Form M.C.Con.1 Notes): '1. The application fee and any other relevant documents are required to be attached to the application. If the fee or document required to be attached is not attached, the application cannot be accepted. ... 3. If the form or any part of the form is illegible or not properly completed the application will be rejected.' Form items 13-18: '13. State the type of sealing for individual packs of condoms (e.g. glue, crimping, etc.) ... 14. State the specifications of the condoms including shelf life ... 15. Summary of methods used to ensure compliance with specifications ... 16. Give details and explanations of all codes on the packaging which appear on an individual pack of condoms ... 17. State number of samples submitted for testing ... 18. I enclose the application fee of ... and undertake to pay the cost for any tests conducted on the condoms and enclose herewith a deposit of ... towards the cost for testing the condoms.'

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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A manufacturer or a local distributor may register; the forms name the manufacturer, importer and distributor

operator.manufacturer-or-local-distributor-may-register
Fact-level verified
Statement

MCAZ states that 'a manufacturer, or a local distributor can register condoms/gloves for distribution in Zimbabwe'. The application forms themselves do not impose a residency requirement on the applicant: Form M.C.Con.1 asks for the particulars of the applicant and its registered office, the name and physical address of the manufacturer, whether there are alternative places or sources of manufacture, and separately the name and address of the importer (if different from the applicant) and of the distributor (if different from the applicant). No local responsible person, authorised representative or power of attorney requirement appears in the device regulations or forms.

Conditions
  • Because there is no device registration guideline, there is no local-agent rule of the kind MCAZ applies to medicine registration.

Verbatim (Form M.C.Con.1, First Schedule): '1. Particulars of applicant ... 6. Name and physical address of manufacturer ... 8. Name and address of importer (if different from item 1 or 2) ... 9. Name and address of distributor (if different from item 1 or 2)'. MCAZ FAQ: 'A manufacturer, or a local distributor can register condoms/gloves for distribution in Zimbabwe.' Approval runs to a type and brand of condom or a type of glove, and the testing fee is borne by 'the importer, manufacturer or wholesaler, as the case may be'.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Every imported batch needs prior approval, and condoms with under six months of shelf life may not be imported

import.batch-approval-and-shelf-life-restriction
Fact-level verified
Statement

Importation of the two regulated device classes is controlled batch by batch rather than by an importer's licence. No importer, manufacturer or wholesaler may sell a condom or a glove unless the batch has been approved for distribution by the Authority, and the application for batch approval is made in duplicate on Form M.C.Con.2 or M.C.G.2. Condoms are subject to an import-specific restriction: no person may import any condom which has less than six months of its shelf life remaining, and no person may sell any condom more than thirty-six months old from its date of manufacture unless the manufacturer supplies satisfactory stability data for a longer shelf life. MCAZ describes the same process in operation as routine compliance checks of all condom and glove batches imported into the country.

Conditions
  • The Import and Export of Medicines Regulations (SI 57 of 2008) and the General Regulations (SI 150 of 1991) are made under section 38(1)(a) for medicines and are not device instruments.
  • There is no device importer's licence or wholesale permit in the device regulations; MCAZ's licence and permit regime (wholesale dealer permits, premises licences) sits in the medicines framework.

Verbatim (Condom Regulations s.10): '(1) No person shall sell any condom, which is more than thirty-six months old from the date of manufacture. Provided that in the case of a type and brand of condoms whose shelf life exceeds thirty six months the manufacturer concerned shall supply satisfactory stability data on such type and brand of condoms. (2) No person shall import any condom, which has less than six months of its shelf life remaining.' Verbatim (s.9(1)): 'No importer, manufacturer or wholesaler, as the case may be, shall sell any condom unless the batch, of which such condom is a part, has been approved for distribution by the Authority.' The Gloves Regulations s.10 is to the same effect for gloves.

Fees

What regulator fee applies to this class, route, event, and date?

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Condom application Z$200,000 and glove application Z$100,000 under the 2005/2006 instruments; retention US$100 and package amendment US$50 since 2014

fees.application-retention-and-amendment-fees
Fact-level verified
Statement

The fee for an application for approval of a type and brand of condom is two hundred thousand dollars under the 2005 regulations, and the fee for an application for approval of a type of glove is one hundred thousand dollars under the 2006 regulations (both figures are in the currency of the time, before the 2014 amendments moved the recurring fees to United States dollars). The 2014 amendments inserted a retention fee and a package amendment fee into each instrument's Third Schedule: the fee payable for the retention of the right to sell a type or brand of glove, and of a type or brand of condom, is US$100, payable on or before 1 April annually, and the fee payable for any package amendment is US$50. Testing costs are additional and are borne by the applicant. MCAZ publishes no separate medical device fee schedule: its medical devices fee schedules page carries only the Laboratory Fee Schedule.

Conditions
  • The 2005 and 2006 application fees are stated in the currency of the time and have not been restated in the device instruments since.
  • The recurring device fees are gazetted in the amending statutory instruments, not in MCAZ's circular fee schedules - the fee schedule published as MCAZ Circular No. 20 of 2023 contains no condom or glove item.
  • The 2014 amendments were published as supplements to the Zimbabwean Government Gazette dated 29 August 2014.

Effective from 2014-08-29

Verbatim (SI 131 of 2014, Condom amendment, s.3): 'The principal regulations are amended in the Third Schedule after "(ii) foreign . . ." by the insertion of the following fees- US$ "Fee payable for the retention of a type or brand of a condom . . . 100,00 | Fee payable for package amendment . . . 50,00".' Verbatim (s.2, new s.14(3)-(4)): 'The fee payable for the retention of the right to sell a type or brand of condom shall be as prescribed in the Third Schedule which shall be payable on or before the 1st April, annually. (4) The fee payable for any package amendment shall be as prescribed in the Third Schedule.' Condom Regulations s.14(1): 'The fee payable in respect of an application for the approval of a type and brand of condom shall be two hundred thousand dollars.' Gloves Regulations s.13(1): 'The fee payable in respect of an application for the approval of a type of glove shall be one hundred thousand dollars.' SI 130 of 2014 inserts the identical US$100 retention and US$50 package amendment for gloves. The 2014 amending instruments are scanned images read by OCR.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Condoms: each individual pack must show date of manufacture and expiry; each package the manufacturer's name and address

label.condom-pack-and-package-marking
Fact-level verified
Statement

Condom labelling is prescribed by regulation rather than by guideline: every condom must be sealed in an individual pack stating the date of manufacture and the date of expiry, and each package of condoms must state the name and address of the manufacturer. No instructions-for-use requirement and no language requirement is stated in the regulations.

Conditions
  • Because the device regulations are silent on language, no English-language labelling duty is imposed on condoms or gloves by the device instruments.

Verbatim (Condom Regulations s.7): '(1) Every condom shall be sealed in an individual pack which shall state thereon the date of manufacture of such condom and the date of expiry. (2) Each package of condoms shall state thereon the name and address of the manufacturer of such condom.' Import and sale controls reinforce the marking: no condom may be sold on a date later than the expiry date on its package, and no condom more than 36 months old from manufacture may be sold without stability data supporting a longer shelf life.

Gloves: each package must state nine prescribed items including batch number, size, sterilisation method, warnings and intended use

label.glove-package-marking-nine-items
Fact-level verified
Statement

Each package of gloves must state the name of the manufacturer and place of manufacture, the date of manufacture, the batch number, the date of expiry if any, the size of gloves, the methods of sterilisation if any, any warnings, the type of lubrication and the intended use. No instructions-for-use document and no language requirement is prescribed.

Verbatim (Gloves Regulations s.8): 'Each package of gloves shall state thereon - (a) the name of manufacturer and place of manufacture; and (b) the date of manufacture; and (c) the batch number; and (d) the date of expiry, if any; and (e) the size of gloves; and (f) the methods of sterilization, if any; and (g) any warnings; and (h) the type of lubrication; and (i) the intended use.' The regulations prohibit selling a glove after its expiry date, which makes the expiry marking on the package operative.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Four statutory forms (M.C.Con.1, M.C.Con.2, M.C.G.1, M.C.G.2) plus the SR 03 device sample receipt form; no online device portal

forms.four-device-forms-and-sample-receipt
Fact-level verified
Statement

Zimbabwe's device process runs on four statutory forms set out in the First Schedules to the two sets of regulations: Form M.C.Con.1 for approval of a type and brand of condom and Form M.C.Con.2 for testing batches of condoms; Form M.C.G.1 for approval of a type of glove and Form M.C.G.2 for testing batches of gloves. Each is submitted in duplicate to the Director-General at MCAZ, 106 Baines Avenue, Harare, or lodged at the Director-General's offices. Alongside them MCAZ operates form SR 03 (Rev 7, October 2020), the Sample Receipt Form - Medical Devices, used by its Samples Repository Office. There is no online device registration portal: MCAZ's Quality Assurance page states that the online sample submission link is 'currently available for Medicines only' and that sample receipt forms 'have to be submitted in person with the samples to the MCAZ Samples Repository Office'. MCAZ publishes registers of approved and retained condoms (MDF 039) and gloves (MDF 040) on its Medical Devices registers page.

Conditions
  • The sample receipt form captures customer details, product details (sample classification, brand, type, manufacturer, country of origin, product licence number, package size, batch number, dates of manufacture and expiry, container size, sample appearance and storage conditions) and requires the customer to accept stated privacy, confidentiality and decision-rule terms.

Verbatim (MCAZ Registers page): 'MDF 039 Rev 2_June 2026 List of approved and retained condom register ... MDF 040 Rev 2_ June 2026 List of approved and retained Gloves Register ...'. Verbatim (MCAZ Quality Assurance page): 'For submission of samples (Medical Devices or Medicines) you can download the forms below, or use the online link which is currently available for Medicines only under Online Services. ... Sample Receipt forms have to be submitted in person with the samples to the MCAZ Samples Repository Office.' Forms named in the First Schedules: 'Form M.C. CON. 1', 'Form M.C.Con. 2', 'Form M.C.G. 1', 'Form M.C.G. 2'. SR 03 Rev 7 (October 2020) is titled 'Sample Receipt Form-Medical Devices'.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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MCAZ carries out cGMP factory inspections of condom and glove manufacturing facilities

qms.cgmp-inspections-condom-and-glove-factories
Fact-level verified
Statement

MCAZ's Strategic Plan 2026-2030 assigns the Medical Devices Unit responsibility for 'Factory inspections (cGMP) of condom and glove manufacturing facilities', alongside the regulation and quality conformity assessment of male condoms (SI 183 of 2005) and medical gloves (SI 1 of 2006). The Medical Devices Unit is listed separately from the Microbiology Unit and from the medicines licensing and inspection functions. No ISO 13485 certification requirement, notified-body system or third-party audit recognition is prescribed in the device regulations, which impose no quality-management-system obligation: approval turns on the product meeting the Second Schedule standards.

Conditions
  • MCAZ's Good Manufacturing Practice Guideline (GL 09) and Good Storage and Distribution Practices guideline (GL 08 Rev 7, August 2023) are written for medical products and medicines; they are not device-specific instruments.

Verbatim (MCAZ Strategic Plan 2026-2030, Medical Devices Unit functions): 'Medical Devices Unit: i. Regulation and Quality Conformity Assessment of male condoms in accordance with SI 183 of 2005 ii. Regulation and Quality Conformity Assessment of medical gloves in accordance with SI 1 of 2006 iii. Factory inspections (cGMP) of condom and glove manufacturing facilities.' The device regulations themselves impose no QMS obligation: approval turns on the product meeting the Second Schedule standards, and the cGMP inspection programme is an administrative practice recorded in the Strategic Plan.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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MCAZ may require withdrawal of a condom or glove batch where necessary for the protection of the public

recall.authority-withdrawal-of-condoms-and-gloves
Fact-level verified
Statement

Each of the device instruments gives the Authority a withdrawal power: where the Authority is of the opinion that the withdrawal of any batch of condoms (or gloves) is necessary for the protection of the public, it may require any person to withdraw such batch in accordance with the procedure it determines. Recalls of registered medicines are handled under MCAZ's separate product defects and recalls function, and the Strategic Plan assigns 'Monitoring product defects & recalls' to the Pharmacovigilance and Clinical Trials Division.

Conditions
  • There is no device field safety corrective action instrument, and no device recall reporting form was found among MCAZ's published device documents.

Verbatim (Condom Regulations s.13): 'Where the Authority is of the opinion that the withdrawal of any batch of condoms is necessary for the protection of the public, the Authority may require any person to withdraw such batch of condoms in accordance with the procedure as determined by the Authority.' Gloves Regulations s.12 is identical except for 'gloves'. The regulation does not prescribe the recall procedure itself - it is 'the procedure as determined by the Authority'.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Two-step pathway: type/brand approval of the device, then batch approval before each shipment may be sold

registration.type-and-brand-approval-plus-batch-release
Fact-level verified
Statement

For the two regulated device classes the pathway has two steps. First, a person who wishes to obtain the Authority's approval of a type and brand of condom applies in duplicate on Form M.C.Con.1, and a person seeking approval of a type of glove applies in duplicate on Form M.C.G.1, each accompanied by the prescribed fee and the appropriate number of samples. Second, and separately, no importer, manufacturer or wholesaler may sell a condom or glove unless the batch of which it is part has been approved for distribution by the Authority; that batch application is made in duplicate on Form M.C.Con.2 or M.C.G.2. MCAZ's own description is that 'Male condoms and medical gloves types and brands are initially registered and granted market authorisation prior distribution' and that 'Routine compliance checks of subsequent shipments is also done for all the condom and glove batches imported into the country.' There is no registration pathway for any other medical device.

Conditions
  • Batch approval is not time-limited by the instrument: for condoms, 'such batch may be sold for such period as determined by the Authority'.
  • MCAZ publishes registers of approved and retained condoms (MDF 039) and gloves (MDF 040) rather than a general device register.

Verbatim (Condom Regulations s.5): 'Any person who wishes to obtain the approval of the Authority for a type and brand of condom shall apply to the Authority, in duplicate, in Form M.C.Con.1 and such application shall be accompanied by - (a) the fee specified in section 14; and (b) the appropriate number of samples as required by the Authority.' Verbatim (s.9(1)): 'No importer, manufacturer or wholesaler, as the case may be, shall sell any condom unless the batch, of which such condom is a part, has been approved for distribution by the Authority.' MCAZ Medical Devices Laboratory page: 'Male condoms and medical gloves types and brands are initially registered and granted market authorisation prior distribution. Routine compliance checks of subsequent shipments is also done for all the condom and glove batches imported into the country.' Type/brand approval is gazetted: where the Authority approves a type and brand of condom (or a type of glove) the Director-General must cause notification of the approval to be published in the Gazette.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Zimbabwe approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Zimbabwe (8 records)

ZimbabweUS FDA · EU conformity assessment · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

No reliance route for medical devices: Zimbabwe operates no general device registration pathway at all

reliance.no-device-registration-route
Fact-level verified
Statement

An FDA, CE, PMDA, MFDS or NMPA approval holder has nowhere to file it in Zimbabwe. Zimbabwe does not operate a general medical device registration pathway: the Medicines and Allied Substances Control Act's registration machinery covers medicines, and devices enter control only through ministerial regulations made under section 38(1)(b). The only device classes ever brought under control are male condoms (SI 183 of 2005) and medical gloves (SI 1 of 2006). For any other device - an infusion pump, an orthopaedic implant, a CT scanner, an IVD - there is no marketing authorisation to apply for, so no foreign approval can open, shorten or substitute for one. MCAZ's own Strategic Plan 2026-2030 records the Medical Devices Unit's entire regulatory function as the assessment of male condoms and medical gloves, and lists an 'expanded scope to medical devices and allied substances' as an effect of a Medical Products and Allied Substances Control Bill that is still only proposed.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

No

Target Decision Retained

Yes

Conditions
  • sourceApproval is recorded as 'none' because there is no device registration route for a foreign approval to attach to. This is a structural no-route, not a policy of refusing foreign approvals.
  • The absence is transitional rather than permanent: the Strategic Plan and the Reliance Policy both look forward to device regulation, but neither has been brought into force.

The claim rests on the Act's long title and structure (Part IV, 'REGISTRATION OF MEDICINES', ss.26-41, is the only registration regime in the Act) read together with the exhaustive MCAZ listing of device instruments (only the Condom Regulations, the Glove Regulations and their 2014 amendments) and the Strategic Plan 2026-2030 statement that the Medical Devices Unit's functions are 'Regulation and Quality Conformity Assessment of male condoms in accordance with SI 183 of 2005', 'Regulation and Quality Conformity Assessment of medical gloves in accordance with SI 1 of 2006' and 'Factory inspections (cGMP) of condom and glove manufacturing facilities'. No device registration guideline, application form or device fee schedule exists in MCAZ's published document set.

ZimbabweWHO

Prior approval / evidence record

MCAZ's operating reliance mechanisms (WHO CRP, expedited, Zazibona, AMA, EDA and SAHPRA MoUs) are medicines registration pathways

reliance.operating-reliance-mechanisms-are-medicines-only
Fact-level verified
Statement

MCAZ does operate abridged and recognition routes, but they are medicines routes. The published reliance pathways are the WHO Collaborative Registration Procedure (3 months), the expedited registration pathway (3 months), the Zazibona SADC Centralised Procedure (3 months, country-level approval) and the African Medicines Agency route (3 months, country-level approval), against 'other products' at 9 months. MCAZ's Reliance Policy adds that an application supported by a replica dossier and the reference authority's full evaluation report can be expedited 'from 16-24 months to 3 months', and it names its functional agreements as the Egyptian Drug Authority (EDA) and the South African Health Products Authority (SAHPRA), with an agreement with the Islamic Republic of Iran Food and Drugs Authority under discussion. The EDA framework itself is titled 'Recognition Framework for Medicines Manufactured in Egypt and Approved by the Egyptian Drug Authority (EDA)' and is 'restricted to products manufactured in Egypt and are currently active on the Egyptian market'. None of these instruments mentions medical devices, and none creates a device route.

Source Approval

Egyptian Drug Authority (EDA) approval; South African Health Products Authority (SAHPRA) approval; WHO Collaborative Registration Procedure; ZAZIBONA/SADC centralised procedure

Edge Type

Cooperation Mou

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • These pathways apply to medicines registration; no equivalent pathway, timeline or MoU was found for medical devices.
  • The EDA recognition framework is limited to products manufactured in Egypt and active on the Egyptian market.
  • The EDA framework requires an EDA-endorsed Quality Information Summary plus a CTD dossier matching it and a cGMP report generated within two years, and commits MCAZ to finalise the application within 30 days of a complete submission.
  • The AMA row on the Key timelines page is a published pathway with a country-level approval caveat; no Zimbabwean instrument giving the AMA legal effect over approvals was found.

Verbatim (MCAZ Key timelines): 'No. Pathway Time (months) 1 WHO Collaborative Registration Procedure 3 2 Expedited registration pathway 3 3 Zazibona (SADC) Centralised Procedure 3* 4 African Medicines Agency (AMA) 3* 5 Complementary medicines 9 6 Veterinary medicines 9 7 Variations 2 8 Other products 9 * Country level approval'. Reliance Policy s.6.1.4(vi): 'MCAZ committing to expedite approval of the product from 16-24 months to 3 months when a replica dossier from the applicant and the full evaluation report from the reference NRA were provided.' EDA framework: 'RECOGNITION FRAMEWORK FOR MEDICINES MANUFACTURED IN EGYPT AND APPROVED BY THE EGYPTIAN DRUG AUTHORITY (EDA) ... The framework is restricted to products manufactured in Egypt and are currently active on the Egyptian market.' The Reliance Policy PDF is a scanned image read by OCR.

ZimbabweNMPA

Prior approval / evidence record

China NMPA medical device registration certificate

Authority

China NMPA medical device registration certificate

Accepted

No

Benefit

No route, and the NMPA is not named in any Zimbabwean device instrument retrieved. An NMPA certificate carries no procedural benefit in Zimbabwe.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ZimbabweWHO

Prior approval / evidence record

WHO prequalification, SRA approval, or a ZAZIBONA / AMA collaborative-registration decision

Authority

WHO prequalification, SRA approval, or a ZAZIBONA / AMA collaborative-registration decision

Accepted

No

Benefit

No device route. MCAZ publishes reliance timelines for medicines only, and the MCAZ Reliance Policy (QPM 09 Revision 3, September 2025) describes reliance in medicines terms — a replica dossier, the reference authority's full unredacted evaluation report, and a commitment to expedite approval 'from 16-24 months to 3 months'. Zimbabwe has no device registration procedure through which such a decision could be taken, and the policy does not create one.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ZimbabweWHO

Prior approval / evidence record

WHO Prequalification for devices and diagnostics is named in the Reliance Policy but deferred until device regulations are approved

reliance.who-prequalification-for-devices-deferred
Fact-level verified
Statement

MCAZ's Reliance Policy (QPM 09, Revision 3, September 2025) provides expressly for reliance on WHO Prequalification - but its registration-reliance section opens 'When MCAZ is conducting evaluation and registration of medicines it considers', and the devices item is written as a future contingency: 'WHO Prequalification for devices and Diagnostics (once the regulations are approved)'. The Authority therefore treats WHO Prequalification of a device or diagnostic as something it will be able to rely on only when Zimbabwe has device regulations to hang it on. It is a declared policy intention, not an operating reliance route, and it does not give a WHO-prequalified device any Zimbabwean market access today.

Source Approval

WHO Prequalification of medical devices and in-vitro diagnostics

Edge Type

International Listing

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The Reliance Policy is issued under the Authority's general powers in section 14 of the Act, not under a device-specific provision.
  • The device item is conditional on the device regulations being approved; those regulations are still in draft and the Strategic Plan describes the enabling Bill as 'proposed'.
  • The other registration-reliance mechanisms listed in the same section are framed for medicines: registration in the country of origin, WHO PQ for medicines and for vaccines, the Zazibona Collaborative Registration Procedure, MoUs with other regulators, and approvals by stringent regulatory authorities.

Effective from 2025-09-26

Verbatim (QPM 09 Rev 3, s.6.1.1): 'When MCAZ is conducting evaluation and registration of medicines it considers i. Registration in the country of origin as a basic minimum. ii. World Health Organisation Prequalification (WHO-PQ) for medicines. iii. WHO Prequalification for vaccines. iv. WHO Prequalification for devices and Diagnostics (once the regulations are approved) v. WHO Emergency Use Listing of medicines or devices in the face of public health emergencies vi. Zazibona Collaborative Registration Procedure vii. Agreements/MoUs signed with other regulators who are willing to share information with MCAZ with the manufacturers' consent. Currently MCAZ has functional agreements with Egyptian Drugs Authority (EDA) and South African Health Products Authority (SAHPRA). In addition, MCAZ is working on further agreements with the Islamic Republic of Iran Food and Drugs Authority (IFDA). viii. Approval by Stringent Regulatory Authorities (European Medicines Agency (EMA), United States Food and Drug Authority (USFDA). Medical Health Products Regulatory Authority (MHPRA), Japan Pharmaceutical and Medical Devices Authority (PMDA), Health Canada, Swissmedic, Australia Therapeutic Goods Administration (TGA)) ix. European Union (EU) Article 58 Scientific Opinion evaluation reports for medicines developed in Europe for use outside EU.' The Reliance Policy PDF is a scanned image; the text was read by OCR and the passages were checked against the surrounding pages.

ZimbabweSource authority not specified

Prior approval / evidence record

A foreign certificate of conformity or free sale certificate

Authority

A foreign certificate of conformity or free sale certificate

Accepted

No

Benefit

Not a substitute for the domestic approvals: the condom and glove conformity assessment is performed by MCAZ's own Medical Devices Laboratory on samples submitted with the application, and the radiation-device licences are issued by RPAZ to the Zimbabwean facility.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ZimbabweSource authority not specified

Prior approval / evidence record

Registration by another SADC authority (ZAMRA, SAHPRA, PPB, TMDA)

Authority

Registration by another SADC authority (ZAMRA, SAHPRA, PPB, TMDA)

Accepted

No

Benefit

No abridgement. SADC and ZAZIBONA procedures cover medicines, and Zimbabwe has no device registration to abridge; a SADC registration cannot substitute for the MCAZ condom or glove type approval or the RPAZ radiation licences.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ZimbabweSource authority not specified

Prior approval / evidence record

For the two regulated device classes, approval is Zimbabwe's own laboratory conformity assessment; a foreign approval is recorded but not recognised

reliance.condom-glove-approval-is-own-conformity-assessment
Fact-level verified
Statement

For the only two regulated device classes the position is still not reliance. Approval of a type and brand of condom or a type of glove turns on whether the device meets Zimbabwe's own Second Schedule standards or standards the Authority specifies from time to time in guidelines; MCAZ's Medical Devices Laboratory performs the conformity assessment, testing condoms for bursting volume and pressure, freedom from holes and visible defects, package seal integrity, dimensions and total lubricant, and gloves for dimensions, watertightness and tensile strength before and after accelerated ageing. MCAZ states that the tests are performed 'in accordance with international standards and WHO guidelines and specifications'. An FDA, CE, PMDA, MFDS or NMPA approval is nowhere recognised or substituted; the foreign paperwork that appears in the process is descriptive - the SR 03 Sample Receipt Form for medical devices records the manufacturer, the 'Country of Origin' and the 'Product license Number' of the sample submitted. Foreign approval is therefore evidence on the file, not a route.

Source Approval

US FDA 510(k)/PMA clearance; EU CE Marking under MDR; Japan PMDA approval; Korea MFDS approval

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The Second Schedule standards themselves are international: the glove schedule specifies sampling and inspection in accordance with ISO 2589-1 with inspection levels and AQLs for physical dimensions, watertightness and tensile strength; the condom schedule specifies batch size, sample size and non-complier allowances for dimensions, package seal, air inflation and water pinhole tests.
  • Approval is per type and brand, and per batch: subsequent shipments of the same approved brand still undergo conformity checking rather than being admitted on the strength of the approval.
  • MCAZ's sample receipt form requires samples to be submitted in person at the MCAZ Samples Repository Office; its online sample submission route is stated to be 'currently available for Medicines only'.

Verbatim (MCAZ Medical Devices Laboratory page): 'MCAZ, Medical devices laboratory does regulation and quality conformity assessment of male condoms and medical gloves. Medical gloves and male condoms are regulated prior to distribution as per SI 1 of 2006 and SI 183 of 2005 respectively. The laboratory is ISO 17025 accredited by SADCAS in condom testing methods. Quality conformity assessment tests of male condoms and medical gloves are performed in accordance with international standards and WHO guidelines and specifications.' Conformity to standards is made the test of approval by Condom Regulations s.4: 'No condom shall be approved by the Authority unless such condom meets the standards as set out in the Second Schedule or as specified by the Authority in guidelines from time to time.' Gloves Regulations s.7 is to the same effect. SR 03 Rev 7 (October 2020) Sample Receipt Form - Medical Devices records 'Manufacturer', 'Country of Origin' and 'Product license Number' for the sample submitted.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

The Authority may in writing exempt any medicine or substance from any or all provisions of the Act, subject to conditions (MASCA s.75)

special.section-75-exemption-power
Fact-level verified

Section 75 of the Medicines and Allied Substances Control Act empowers MCAZ to exempt, in writing and subject to any conditions it specifies, any medicine or substance from the operation of any or all provisions of the Act; this is the legal basis for 'Section 75 authorisations' to import unregistered products.

Conditions
  • The power is expressed for 'any medicine or substance'; 'medicine' is defined in s.2 'subject to section seventy-five' as any substance used in diagnosis, treatment, mitigation or prevention of disease. Condoms and gloves are controlled through regulations made under ss.38 and 74, and neither the Act nor the device regulations state whether s.75 authorisations are issued for devices.

Effective from 1997-08-01

Section 2: '“medicine”, subject to section seventy-five, means any substance or mixture of substances which is used, or is manufactured, sold or represented as suitable for use, in— (a) the diagnosis, treatment, mitigation or prevention of disease or any abnormal physical or mental state or the symptoms thereof in man or in animals; or (b) restoring, correcting or modifying any physical, mental or organic function in man or in animals;'.

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

Condoms are approved only if they meet the Second Schedule standards or MCAZ guidelines; Part II lists performance requirements verified by laboratory testing with ISO 2859-1 sampling and AQL 1.5 (SI 183 of 2005, s.4 and Second Schedule)

standards.condom-second-schedule-performance-requirements-iso-2859-sampling
Fact-level verified

No condom may be approved unless it meets the standards in the Second Schedule or as specified by the Authority in guidelines. The Second Schedule fixes batch-size/sample-size/non-complier tables (dimensions, package seal, air inflation, water pinhole) in Part I and, in Part II, performance requirements (burst volume and burst pressure before and after oven conditioning, freedom from holes, visible defects) verified by laboratory testing under ISO 2859-1 inspection level G-1 with AQL 1.5, plus dimensional and lubricant requirements at level S-2/S-3.

Conditions
  • Condoms only; gloves have their own Second Schedule (already recorded).

Effective from 2005-01-01

The 'SECTION' column (3.2, 3.3) references clauses of an underlying condom standard that the schedule does not name; MCAZ's laboratory page states testing is to ISO and WHO condom specifications.

Conformity assessment is done by MCAZ's own ISO 17025 accredited laboratory against the Second Schedule standards

testing.mcaz-laboratory-conformity-assessment-and-standards
Fact-level verified
Statement

Approval depends on the product meeting the standards in the Second Schedule to the relevant regulations, or standards the Authority specifies from time to time in guidelines, and the testing is performed by MCAZ's Medical Devices Laboratory. The laboratory is ISO 17025 accredited by SADCAS in condom testing methods, and quality conformity assessment is performed 'in accordance with international standards and WHO guidelines and specifications'. Condoms are tested for bursting volume and pressure, freedom from holes and visible defects, package seal integrity, dimensional testing (length, width and thickness) and total lubricant content; gloves are tested for dimensions, watertightness and tensile strength and elongation at break before and after accelerated ageing, with sampling in accordance with ISO 2589-1 and specified inspection levels and AQLs. Costs of testing are borne by the importer, manufacturer or wholesaler.

Conditions
  • There is no notified-body, conformity-assessment-body or third-party test-report recognition scheme for devices; MCAZ's own laboratory is the conformity assessment body.
  • The Second Schedule to the Condom Regulations sets batch sizes, sample sizes and permitted non-compliers for dimensions, package seal, air inflation and water pinhole tests.

Verbatim (Gloves Regulations s.7): 'No glove shall be approved by the Authority unless such glove meets the standards as set out in the Second Schedule or as specified by the Authority in guidelines from time to time.' Second Schedule: 'Gloves shall be sampled and inspected in accordance with ISO 2589-1. The inspection levels and acceptable quality levels (AQLs) shall conform to those specified in Table 1 for the characteristics listed.' Table 1: 'Physical dimensions (width, length, thickness) Inspection Level S-2 AQL 4,0 / Watertightness S-4 2,5 / Tensile strength and elongation at break (before and after accelerated ageing) S-2 4,0'; Table 2 sets minimum thicknesses of 0.08 mm for smooth areas and 0.11 mm for textured areas. Condom Regulations s.14(2): 'Any costs incurred in testing any condoms for the purpose of obtaining approval in terms of section 5 or 9 shall be borne by the importer, manufacturer or wholesaler, as the case may be.' MCAZ Medical Devices Laboratory page lists the condom tests and states the laboratory 'is ISO 17025 accredited by SADCAS in condom testing methods'.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

A decision of the Authority under MASCA is appealed to the Administrative Court by written notice within 30 days

appeal.administrative-court-within-30-days
Fact-level verified

Part VII of the Medicines and Allied Substances Control Act gives any person aggrieved by a decision of the Authority in terms of the Act a right of appeal to the Administrative Court, exercised by notice in writing filed within 30 days after the date of the decision. It is the general statutory remedy and it is unqualified as to the kind of decision or the kind of product, so a refusal or a condition-laden approval in the device instruments falls to be challenged there. The device instruments prescribe no review, reconsideration or appeal procedure of their own: the Condom Regulations 2005 and the Gloves Regulations 2006 provide for approval of a type and brand (and separately of each batch) but create no internal challenge route against the Authority's decision.

Conditions
  • The appeal is to the Administrative Court, not to the Authority or to the Minister; there is no internal reconsideration stage in the device instruments.
  • The Act's own registration part is drafted for 'medicines' and directs a refused applicant to Part VII (section 33(2)(b)); the device instruments made under section 74 and section 38 fix no separate appeal route, so this general remedy is the one that applies.
  • Section 33(6)'s proviso, which bars gazetting a refusal until the 30-day appeal period has expired or the appeal is determined, is written for medicines.

MASCA [Chapter 15:03] consolidated text, retrieved 2026-09-16 over direct HTTPS (HTTP 200, application/pdf, 628037 bytes). Section 62 was substituted by Act 1 of 1996 with effect from 1 August 1997 per the consolidation's marginal note. What is quoted is the whole of section 62 — the section has no subsections.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Supply-chain stakeholders must keep traceability records for a year past expiry and report identifier errors or losses to MCAZ within 48 / 24 hours

traceability.traceability-records-and-48-hour-error-reporting
Fact-level verified

Under MCAZ's traceability guideline the brand owner or manufacturer must share the unique-identifier data of a medical product with the Authority before placing it on the market, and supply-chain stakeholders must electronically capture and share the unique identifier together with its associated traceability information (date, time and time zone of manufacture, receipt and distribution or dispensing; physical location; source received from; destination distributed to; GSRN and master data of handlers where available; logistics processing; disposition including in transit, expired, recalled, stolen, sold and dispensed; and any other information the Authority requires). Records of the linkage between products created, received, processed or dispatched must be kept for a minimum of one year after the expiry date of the product and transmitted to the Authority on request. Identified errors in the unique-identifier data must be captured and shared with the Authority within 48 hours of becoming aware of them; where a data carrier cannot be scanned the manufacturer or supply-chain stakeholder must inform the Authority within 48 hours before taking any further action; and stolen or lost medical products must be reported with their unique identifier within 24 hours.

Conditions
  • The record-keeping and reporting duties in §5.1.10.4 and §5.1.12.1 are addressed to 'pharmaceutical supply chain stakeholders' and the record-retention clause speaks of the 'pharmaceutical product'; the pre-market sharing duty in §5.1.10.1 is addressed to the 'brand owner or manufacturer' of the product.
  • Records must be transmitted to the Authority on request; the guideline creates no periodic reporting cycle of its own.
  • The obligations are phased in by §5.3.

Same instrument and retrieval as the preceding fact. §5.1.10.4's roman numeral markers are mis-set in the published PDF (the list runs i, ii, iii, iv, v, vi across wrapped lines); the quoted sentences are transcribed exactly as printed, without guessing at the numbering.

Medical products placed on the Zimbabwean market must carry a unique identifier encoded in a GS1 data matrix

traceability.unique-identifier-and-gs1-data-carrier
Fact-level verified

MCAZ's traceability guideline applies to the traceability of medical products manufactured, imported, exported, advertised, sold, distributed or used in Zimbabwe. A medical product placed on that market must be identified with a unique identifier created and assigned by the brand owner, and that unique identifier must consist of the GTIN, the batch or lot number, the expiry date and the serial number at primary and secondary packaging level (GTIN, batch or lot number and expiry date at tertiary level). The unique identifier of the primary and secondary package must be encoded in a GS1 data matrix. The guideline admits only a closed list of exceptions, none of which is a general device carve-out: pharmaceutical product imported for personal use, unregistered medical product imported with the Authority's approval, medical product for clinical trials, medical product for research purposes, extemporaneous preparations, and any other product approved by the Authority.

Conditions
  • The guideline's umbrella term is 'medical products'; it never defines that term or 'medical device', and its definitions section is pharmaceutical-supply-chain framed (4.7, 4.13, 4.15 and 4.23 all say 'pharmaceutical'). Device applicability therefore rests on the guideline's own umbrella wording and on its publication in MCAZ's Medical Devices documents list, not on a definitional clause.
  • The compliance duty is enforceable through the Medicines and Allied Substances Control Act and SI 150 of 1991 (guideline §5.1.14).
  • The guideline sets phase-in periods for the traceability obligations (§5.3: 0-12, 12-36 and 36-60 months from publication).

MCAZ/LED/GL-22 Rev 0, July 2025, retrieved 2026-09-16 over direct HTTPS (HTTP 200, application/pdf, 232804 bytes). §1.0 and §5.1.2 say 'medical products'; §5.1.10.4 by contrast addresses 'pharmaceutical supply chain stakeholders' and speaks of a 'pharmaceutical product', and MCAZ's GDP guideline MCAZ/LED/GL-08 Rev 6 §4.10.3 treats 'medicinal products' and 'medical devices' as separate categories — that is a real internal-tightness caveat, but the scope clause §1.0 and the §5.1.13.2 exemption list are both written in terms of medical products and neither excludes devices, so the bounded claim above is what the quoted passage supports.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

MCAZ pharmacovigilance and clinical trials functions are stated to cover medical devices, but no device reporting duty is prescribed

vigilance.pharmacovigilance-covers-medical-devices-generically
Fact-level verified
Statement

MCAZ's Strategic Plan 2026-2030 lists among the Pharmacovigilance and Clinical Trials Division's functions 'Pharmacovigilance (PV) (safety monitoring of medicines, vaccines & medical devices) including active PV programs & projects', 'Monitoring product defects & recalls', and 'Regulation of clinical trials of medicines, vaccines & medical devices, including Good Clinical Practice (GCP) inspections'. MCAZ's Reliance Policy similarly provides that in vigilance it 'considers vigilance related decisions, reports or information from other countries, regional or international bodies such as WHO in making decisions on the safety and effectiveness of medical products', from WHO global pharmacovigilance newsletters and databases, WHO listed countries, and any other countries or bodies with functional and reliable pharmacovigilance systems. Neither instrument creates a device-specific adverse-event reporting duty, timeframe or field safety notice procedure, and the device regulations themselves contain no vigilance clause.

Conditions
  • The Reliance Policy's vigilance section is drafted broadly enough to cover devices ('medical products') but describes how MCAZ uses other authorities' safety information internally; it creates no route to market.
  • For the two regulated device classes the operative safety mechanism is batch-level: batch approval before sale, batch conformity checking of imported shipments, and withdrawal powers.

Verbatim (MCAZ Strategic Plan 2026-2030, PVCT Division functions): 'i. Pharmacovigilance (PV) (safety monitoring of medicines, vaccines & medical devices) including active PV programs & projects. ... vi. Monitoring product defects & recalls.' Reliance Policy QPM 09 Rev 3 s.6.5: 'The MCAZ continually ensures the safety of marketed products through its established Pharmacovigilance system. ... The MCAZ considers vigilance reports and decisions from the following: 1. WHO Global pharmacovigilance newsletters, and databases. 2. WHO listed countries. 3. Any other countries or bodies with functional and reliable pharmacovigilance systems.'

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record
Open Zimbabwe registration →
Country

Zimbabwe

Jurisdiction Id

zimbabwe

Country Code

ZW

Flag

🇿🇼

Regulator

Medicines Control Authority of Zimbabwe

Regulator Abbrev

MCAZ

Region

africa

Tier

3

Risk Classification

None. Zimbabwe operates no risk-classification axis for medical devices and no general device registration pathway: medical devices are reachable only through the regulation-making power in s.38 of the Medicines and Allied Substances Control Act [Chapter 15:03], under which only the Condom Regulations (S.I. 183 of 2005) and the Glove Regulations (S.I. 1 of 2006) have been made, and those apply by product type rather than by risk class. The clocks published here are the Radiation Protection Authority's licensing service standards for radiation devices — the only device-facing approval periods Zimbabwe publishes.

Classes
  • Id

    rpaz-import-licence-radiation-device

    Class Name

    Ionising-radiation import licence — radiation devices and radioactive sources (RPAZ)

    Risk Level

    high

    Pathway

    Application to the Radiation Protection Authority of Zimbabwe for an import licence for a radiation device or radioactive source, under the Radiation Protection Act [Chapter 15:15] and the Radiation Protection (Safety and Security of Radiation Sources) Regulations (S.I. 62 of 2011)

    Official Timeline
    Min

    3

    Max

    3

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Radiation Protection Authority of Zimbabwe, Client Service Charter, RPAZ/CH/LCA-02, Version 2.0, January 2026 — section 8.0 Service Commitments and Standards, 'Licensing of radiation devices'

    Url

    https://www.rpaz.co.zw/wp-content/uploads/2026/08/CLIENT-SERVICE-CHARTER-2026.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    3

    Notes
    • The clock is RPAZ's published service standard in section 8.0 of its Client Service Charter 2026 (RPAZ/CH/LCA-02, Version 2.0, January 2026): 'Licensing of radiation devices — Import license Within 3 working days'.
    • It is a service-charter commitment rather than a statutory period, and the charter states that the service standard timelines are premised on the assumption that the client has met all regulatory requirements. The realistic band therefore adds the time an applicant needs to assemble a complete application and to satisfy the licence preconditions.
    • The import licence is route-wide: it is granted for a radiation device irrespective of any risk class, and Zimbabwe has no risk-class axis for devices to link it to.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    rpaz-use-licence-radiation-device

    Class Name

    Licence to use a radiation device — new application and renewal (RPAZ)

    Risk Level

    high

    Pathway

    Application to RPAZ for a licence to use a radiation device, in the prescribed form with the prescribed fee, under s.15(2) of the Radiation Protection Act [Chapter 15:15]; the licence is what authorises the holder to install, use, operate or dispose of an irradiating device under s.15(4)(b)

    Official Timeline
    Min

    30

    Max

    30

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Radiation Protection Authority of Zimbabwe, Client Service Charter, RPAZ/CH/LCA-02, Version 2.0, January 2026 — section 8.0 Service Commitments and Standards, 'Licensing of radiation devices'

    Url

    https://www.rpaz.co.zw/wp-content/uploads/2026/08/CLIENT-SERVICE-CHARTER-2026.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    5

    Notes
    • Section 8.0 of the RPAZ Client Service Charter 2026 publishes 'License to use a radiation device — New application Within 30 days; Renewal Within 14 days'. The row carries the new-application period; renewal is the same route at 14 days.
    • The same charter section publishes the neighbouring clocks an importer will meet: store and possess licence 30 days new / 7 days renewal, export licence 60 days, transport permit 7 days, transit permit 1 day, design approval certificate 5 working days, registration of low-risk practices 14 days new / 7 days renewal, and exemption of materials outside regulatory control 1 day.
    • The licence attaches to the facility that operates the equipment — RPAZ's list of activities requiring authorisation names medical diagnostic and interventional radiology (including x-ray machines, CT scanners, mammography, fluoroscopy and Gamma Knife/Cyber Knife), radiotherapy and nuclear medicine — so the applicant is a Zimbabwean hospital, clinic or service provider, not the foreign manufacturer.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    rpaz-design-approval-radiation-device

    Class Name

    Design approval certificate — radiation device (RPAZ)

    Risk Level

    high

    Pathway

    Application to RPAZ for a design approval certificate for a radiation device or its shielding, alongside the import and use licences

    Official Timeline
    Min

    5

    Max

    5

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Radiation Protection Authority of Zimbabwe, Client Service Charter, RPAZ/CH/LCA-02, Version 2.0, January 2026 — section 8.0 Service Commitments and Standards, 'Licensing of radiation devices'

    Url

    https://www.rpaz.co.zw/wp-content/uploads/2026/08/CLIENT-SERVICE-CHARTER-2026.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • Published in section 8.0 of the RPAZ Client Service Charter 2026 as 'Design approval certificate Within 5 working days', under the heading 'Licensing of radiation devices'.
    • This is the closest thing Zimbabwe publishes to a product-level approval for a radiation-emitting device: it is the Authority's approval of the device design rather than a registration certificate, and it is route-wide rather than class-specific.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    WHO prequalification, SRA approval, or a ZAZIBONA / AMA collaborative-registration decision

    Accepted

    No

    Benefit

    No device route. MCAZ publishes reliance timelines for medicines only, and the MCAZ Reliance Policy (QPM 09 Revision 3, September 2025) describes reliance in medicines terms — a replica dossier, the reference authority's full unredacted evaluation report, and a commitment to expedite approval 'from 16-24 months to 3 months'. Zimbabwe has no device registration procedure through which such a decision could be taken, and the policy does not create one.

  • Authority

    Registration by another SADC authority (ZAMRA, SAHPRA, PPB, TMDA)

    Accepted

    No

    Benefit

    No abridgement. SADC and ZAZIBONA procedures cover medicines, and Zimbabwe has no device registration to abridge; a SADC registration cannot substitute for the MCAZ condom or glove type approval or the RPAZ radiation licences.

  • Authority

    China NMPA medical device registration certificate

    Accepted

    No

    Benefit

    No route, and the NMPA is not named in any Zimbabwean device instrument retrieved. An NMPA certificate carries no procedural benefit in Zimbabwe.

  • Authority

    A foreign certificate of conformity or free sale certificate

    Accepted

    No

    Benefit

    Not a substitute for the domestic approvals: the condom and glove conformity assessment is performed by MCAZ's own Medical Devices Laboratory on samples submitted with the application, and the radiation-device licences are issued by RPAZ to the Zimbabwean facility.

Key Requirements
  • 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.
Local Rep Required

Yes

Local Rep Name

A local licensed importer, manufacturer or wholesaler for condoms and gloves (the Regulations bind those persons, and the forms require the importer's name and address); the RPAZ radiation licences are held by the Zimbabwean facility that imports or uses the equipment

Mdsap Accepted

No

Mdsap Benefit

MDSAP is not named in any Zimbabwean device instrument retrieved, and there is no device registration procedure in which a quality-management-system certificate could be accepted.

Registration Validity

No device registration certificate exists. A condom or glove type-and-brand approval is retained by paying the annual retention fee on or before 1 April each year; RPAZ licences, permits and the design approval certificate are separately issued and renewed through the applications above.

Last Updated

2026-09-16

Verification Status

partially-verified

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by MCAZ. Appoint a A local licensed importer, manufacturer or wholesaler for condoms and gloves (the Regulations bind those persons, and the forms require the importer's name and address); the RPAZ radiation licences are held by the Zimbabwean facility that imports or uses the equipment.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to MCAZ including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    MCAZ reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. MCAZ may issue questions.

    Duration

    3 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, MCAZ issues Zimbabwe market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Zimbabwe fees →
Jurisdiction Id

zimbabwe

Country

Zimbabwe

Country Code

ZW

Authority

MCAZ

Low Risk Local
Min

100

Max

100

Currency

USD

Per Product

Yes

High Risk Local
Min

100

Max

100

Currency

USD

Per Product

Yes

Details
  • Id

    condom-type-retention

    Item

    Retention of the right to sell a type or brand of condom

    Currency

    USD

    Amount Local

    100

    Amount Local Formatted

    US$ 100.00

    Frequency

    Annually, payable on or before 1 April

    Notes

    Statutory Instrument 131 of 2014 inserts a new s.14(3) into the Condom Regulations 2005 and a fee into the Third Schedule under a 'US$.' column: 'Fee payable for the retention of a type or brand of condom … 100,00'. This is the recurring device fee for the only device class Zimbabwe registers by type and brand.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.mcaz.co.zw/wp-content/uploads/2022/04/si-131-of-2014.pdf

    Source Title

    Medicines and Allied Substances Control (Condom) (Amendment) Regulations, 2014 (No. 4) — Statutory Instrument 131 of 2014, Third Schedule ('US$.' column): retention of a type or brand, and package amendment

    Source Effective Date

    2014-08-29

    Verified On

    2026-09-16

  • Id

    condom-package-amendment

    Item

    Package amendment for a condom type or brand

    Currency

    USD

    Amount Local

    50

    Amount Local Formatted

    US$ 50.00

    Frequency

    Per amendment

    Notes

    Same instrument and same Third Schedule column: 'Fee payable for package amendment … 50,00', inserted as the new s.14(4) of the Condom Regulations 2005.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.mcaz.co.zw/wp-content/uploads/2022/04/si-131-of-2014.pdf

    Source Title

    Medicines and Allied Substances Control (Condom) (Amendment) Regulations, 2014 (No. 4) — Statutory Instrument 131 of 2014, Third Schedule ('US$.' column): retention of a type or brand, and package amendment

    Source Effective Date

    2014-08-29

    Verified On

    2026-09-16

  • Id

    condom-batch-testing-private

    Item

    MCAZ Medical Devices Laboratory — condom testing, private sector (all batch sizes)

    Currency

    USD

    Amount Local

    350

    Amount Local Formatted

    US$ 350.00

    Frequency

    Per batch

    Notes

    Laboratory Fee Schedule item 15.0, under the heading 'TEST FEES (USD)'. Batch approval under s.9 of the Condom Regulations 2005 is what makes a batch saleable, so this is the fee an importer actually pays per consignment.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.mcaz.co.zw/wp-content/uploads/2024/05/LABORATORY-FEE-SCHEDULE.pdf

    Source Title

    MCAZ Laboratory Fee Schedule FIN 011, Rev 2 June 2023 — 'TEST FEES (USD)', items 15.0 Condom Testing and 16.0 Glove Testing

    Verified On

    2026-09-16

  • Id

    condom-batch-testing-public

    Item

    MCAZ Medical Devices Laboratory — condom testing, public sector (all batch sizes)

    Currency

    USD

    Amount Local

    280

    Amount Local Formatted

    US$ 280.00

    Frequency

    Per batch

    Notes

    Laboratory Fee Schedule item 15.0, public-sector rate. The schedule publishes the two rates side by side rather than a band.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.mcaz.co.zw/wp-content/uploads/2024/05/LABORATORY-FEE-SCHEDULE.pdf

    Source Title

    MCAZ Laboratory Fee Schedule FIN 011, Rev 2 June 2023 — 'TEST FEES (USD)', items 15.0 Condom Testing and 16.0 Glove Testing

    Verified On

    2026-09-16

  • Id

    glove-testing

    Item

    MCAZ Medical Devices Laboratory — glove testing (all sizes)

    Currency

    USD

    Amount Local

    150

    Amount Local Formatted

    US$ 150.00

    Frequency

    Per batch

    Notes

    Laboratory Fee Schedule item 16.0 GLOVE TESTING All Sizes 150.00. The schedule publishes a single rate for gloves, with no public-sector differentiation.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.mcaz.co.zw/wp-content/uploads/2024/05/LABORATORY-FEE-SCHEDULE.pdf

    Source Title

    MCAZ Laboratory Fee Schedule FIN 011, Rev 2 June 2023 — 'TEST FEES (USD)', items 15.0 Condom Testing and 16.0 Glove Testing

    Verified On

    2026-09-16

Notes
  • The currency is the currency the tariff itself states. Statutory Instrument 131 of 2014 publishes the retention and package-amendment fees under a column headed 'US$.' and MCAZ's Laboratory Fee Schedule is headed 'TEST FEES (USD)'; Zimbabwe's domestic currency is the Zimbabwe Gold (ZWG), but no ZWG figure appears in either device tariff, and converting the published US-dollar amounts into ZWG would replace a published amount with a rate of the day.
  • Zimbabwe publishes no device registration fee, because it has no general device registration pathway. The only device-specific fee heads in force are the condom retention and package-amendment fees created by S.I. 131 of 2014 and the MCAZ laboratory testing fees for condoms and gloves. Both summary bands therefore carry the same US$ 100.00 figure (the annual per-type retention fee): Zimbabwe operates no risk-classification axis, so no fee is differentiated by class.
  • The principal 2005 and 2006 Regulations set their original application fees in the currency of that time — s.14 of the Condom Regulations 2005 states that the fee for approval of a type and brand of condom 'shall be two hundred thousand dollars' and s.14 of the Gloves Regulations 2006 states 'one hundred thousand dollars'. Those figures are in the Zimbabwe dollar of 2005/2006 and cannot be restated as a current US-dollar amount; they are recorded here rather than published as a fee row.
  • MCAZ laboratory prices exclude 15% VAT, as the schedule states on its last page.
  • The fee schedule's other heads are medicines, cosmetics and veterinary heads; no medical-device head exists in Zimbabwe's published fee instruments other than the condom and glove items above.
  • Statutory Instrument 131 of 2014 was read by OCR from a scanned gazette PDF: the fee column header renders as 'USS.' in OCR and is a 'US$.' column in the instrument, and both amounts (100,00 and 50,00) were read from that column.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Medicines and Allied Substances Control (Condom) (Amendment) Regulations, 2014 (No. 4) — Statutory Instrument 131 of 2014, Third Schedule ('US$.' column): retention of a type or brand, and package amendment

    Url

    https://www.mcaz.co.zw/wp-content/uploads/2022/04/si-131-of-2014.pdf

    Effective Date

    2014-08-29

    Accessed Date

    2026-09-16

  • Title

    MCAZ Laboratory Fee Schedule FIN 011, Rev 2 June 2023 — 'TEST FEES (USD)', items 15.0 Condom Testing and 16.0 Glove Testing

    Url

    https://www.mcaz.co.zw/wp-content/uploads/2024/05/LABORATORY-FEE-SCHEDULE.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Zimbabwe certifications →
Slug

zimbabwe

Market

Zimbabwe

Confidence

low

Schemes
  • Id

    mcaz-condom-and-glove-conformity-assessment

    Name

    MCAZ condom and glove type approval and batch release

    Category

    Product Specific Conformity

    Status

    Included In Medical Registration

    Object

    Condom Or Medical Glove

    Note

    Male condoms and medical gloves are the only medical-device classes the Medicines Control Authority of Zimbabwe controls, through the Medicines and Allied Substances Control (Condom) Regulations, 2005 (S.I. 183 of 2005) and the (Gloves) Regulations, 2006 (S.I. 1 of 2006), made under s.38 of the Medicines and Allied Substances Control Act [Chapter 15:03]. The applicant first obtains approval of a type and brand on Form M.C.Con.1 (condoms) or Form M.C.G.1 (gloves), with the statutory fee and samples, and the Director-General publishes the approval in the Gazette; no person may then sell any condom or glove unless the batch has been separately approved on Form M.C.Con.2 or M.C.G.2, which is why the fee schedule carries condom and glove batch-testing heads. Conformity is assessed by MCAZ's own Medical Devices Laboratory against the standards in the Second Schedule, so an importer's obligation is a Zimbabwean approval, not a foreign certificate.

    Source Urls
    • https://www.mcaz.co.zw/wp-content/uploads/2022/01/Condom-Regulations_2005.pdf
    • https://www.mcaz.co.zw/wp-content/uploads/2022/01/Gloves-Regulations-2006.pdf
    Source Binding

    reviewed

  • Id

    potraz-equipment-type-approval

    Name

    POTRAZ equipment type approval

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Covered Radio Or Terminal Equipment

    Note

    The Postal and Telecommunications Regulatory Authority of Zimbabwe publishes an Equipment Type Approval Application Form that applicants lodge for radio, telephone, PABX, modem and other telecommunications equipment, declaring the equipment's technical specifications and attaching test reports, and the form records an approval status and a certificate issue. A medical device with a radio or telecommunications function must therefore obtain POTRAZ type approval in addition to anything MCAZ requires. The binding is candidate because POTRAZ's own type-approval pages could not be retrieved from potraz.gov.zw during this review, so only the Authority's published application form is cited and no statutory section or period is asserted.

    Source Urls
    • https://www.potraz.gov.zw/wp-content/uploads/2015/04/TypeApprovalApplicarionForm.pdf
    Source Binding

    candidate

  • Id

    rpaz-ionising-radiation-authorisation

    Name

    RPAZ authorisation for radiation sources and irradiating devices

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Radiation Product Importer Or Use Site

    Note

    The Radiation Protection Authority of Zimbabwe licenses ionising-radiation practices under the Radiation Protection Act [Chapter 15:15] (Act 5 of 2004). Section 14(1) provides that no person shall mine, manufacture, import, export, distribute, sell, possess, use, operate, maintain, transport or dispose of a radiation source or irradiating device except in accordance with prescribed requirements, s.15(1) prohibits administering ionizing radiation without a valid licence, s.15(2) requires the application to be in the prescribed form with the prescribed fee, and s.15(4)(b) gives the licence holder the right to own, purchase, acquire, import, export, possess, sell or deal in, install, use or dispose of irradiating devices and other sources of ionizing radiation. RPAZ's own list of activities requiring authorisation names medical diagnostic and interventional radiology (fixed and mobile x-ray machines, C-arms, fluoroscopy, mammography, bone densitometry, CT scanners, Gamma Knife, Cyber Knife), radiotherapy, nuclear medicine, dental and veterinary radiography, and service providers who supply, install or maintain radiation equipment. The obligation falls on the importing or using facility rather than on a product registration, so a Zimbabwean hospital or clinic must hold the licence before it operates the equipment.

    Source Urls
    • https://www.rpaz.co.zw/licensing-2/activities-requiring-authorization/
    • https://www.rpaz.co.zw/Downloads/Radiation%20Protection%20Act.pdf
    • https://www.rpaz.co.zw/wp-content/uploads/2026/08/CLIENT-SERVICE-CHARTER-2026.pdf
    Source Binding

    reviewed

  • Id

    saz-consignment-based-conformity-assessment

    Name

    SAZ consignment based conformity assessment (destination inspection)

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Imported Goods Consignment

    Note

    Zimbabwe's Ministry of Industry and Commerce appointed the Standards Association of Zimbabwe as the Destination Inspection Service Provider for verification of conformity when goods and vehicles arrive at ports of entry without the necessary pre-shipment inspection certificates; the programme started on 1 June 2022 and replaced the Ministry's exemption letters. Destination inspection applies to goods controlled under SI 35:2024 and to goods and vehicle spare parts of a minimum FOB value of US$1,000.00 (all motor vehicles without pre-shipment certificates are inspected regardless of value); the applicant registers on the SAZ portal, requests an inspection, pays, and receives a verifiable e-Certificate of Conformity, a Certificate of Non-Conformity or a Conditional Certificate of Conformity, which ZIMRA uses to clear the consignment. The SAZ page does not enumerate the controlled goods, so whether a given medical device consignment falls inside SI 35:2024 is not evidenced here and would need confirmation with SAZ or the Ministry.

    Source Urls
    • https://www.saz.org.zw/consignment-based-conformity-assessment/
    Source Binding

    reviewed

Official Sources
  • Authority

    MCAZ

    Topic

    Medicines and Allied Substances Control (Condom) Regulations, 2005 (S.I. 183 of 2005) — type and brand approval and batch approval

    Url

    https://www.mcaz.co.zw/wp-content/uploads/2022/01/Condom-Regulations_2005.pdf

  • Authority

    MCAZ

    Topic

    Medicines and Allied Substances Control (Gloves) Regulations, 2006 (S.I. 1 of 2006) — type and batch approval

    Url

    https://www.mcaz.co.zw/wp-content/uploads/2022/01/Gloves-Regulations-2006.pdf

  • Authority

    POTRAZ

    Topic

    equipment type approval application form

    Url

    https://www.potraz.gov.zw/wp-content/uploads/2015/04/TypeApprovalApplicarionForm.pdf

  • Authority

    RPAZ

    Topic

    activities requiring authorisation — radiation devices and practices

    Url

    https://www.rpaz.co.zw/licensing-2/activities-requiring-authorization/

  • Authority

    RPAZ

    Topic

    Radiation Protection Act [Chapter 15:15] — licensing of radiation sources and irradiating devices

    Url

    https://www.rpaz.co.zw/Downloads/Radiation%20Protection%20Act.pdf

  • Authority

    RPAZ

    Topic

    Client Service Charter 2026 (RPAZ/CH/LCA-02) — published licensing service standards

    Url

    https://www.rpaz.co.zw/wp-content/uploads/2026/08/CLIENT-SERVICE-CHARTER-2026.pdf

  • Authority

    SAZ

    Topic

    consignment based conformity assessment (destination inspection) — conditions and procedure

    Url

    https://www.saz.org.zw/consignment-based-conformity-assessment/

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