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MCAZ Β· structured requirements

πŸ‡ΏπŸ‡Ό Zimbabwe IVD regulatory data

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

1 facts1 dimensions1 official sourceslatest verification 2026-09-16
Explore questions and sources β†’

Common questions about changing a registered IVD in Zimbabwe. Each question separates published rules from details still awaiting verification.

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

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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: 'β€œmedicine”, 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, inβ€” (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;'.

Related structured datasets

Classification systems Β· 0 records

No maintained record.

Registration pathways, prior approvals and planning Β· 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Zimbabwe registration β†’
Country

Zimbabwe

Jurisdiction Id

zimbabwe

Country Code

ZW

Flag

πŸ‡ΏπŸ‡Ό

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 β€” the only device-facing approval periods Zimbabwe publishes.

Classes
  • Id

    rpaz-import-licence-radiation-device

    Class Name

    Ionising-radiation import licence β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” 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 β€” the Client Service Charter states that 'the service standard timelines are premised on the assumption that the client has met all regulatory requirements' β€” 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 β€” 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 β€” except for motor vehicles β€” 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

    πŸ“‹

  • 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

    πŸ“€

  • Step

    3

    Title

    Administrative Review

    Description

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

    Duration

    2-4 weeks

    Icon

    πŸ”

  • Step

    4

    Title

    Technical Evaluation

    Description

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

    Duration

    3 working days

    Icon

    βš™οΈ

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, MCAZ issues Zimbabwe market authorization certificate.

    Duration

    1-2 weeks

    Icon

    βœ…

Government fee schedules Β· 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Zimbabwe fees β†’
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) β€” 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) β€” 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 β€” 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 β€” '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 β€” 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 β€” '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 β€” 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 β€” '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 β€” 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) β€” 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 β€” '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 Β· 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Zimbabwe certifications β†’
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) β€” 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) β€” 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 β€” radiation devices and practices

    Url

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

  • Authority

    RPAZ

    Topic

    Radiation Protection Act [Chapter 15:15] β€” 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) β€” 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) β€” conditions and procedure

    Url

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

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DJ Fang
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