Zimbabwe medical device regulatory resources

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

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 registrati…

Legal basis: Act Chapter 15:03 section 38(1)(b), with device control only through the Condom Regulations 2005 and Gloves Regulations 2006

statement: Medical device control in Zimbabwe rests on the Medicines and Allied Substances Control Act [Chapter 15:03] section 38(1)(b), which lets the Minister of Health, after consulting…

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

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 sp…

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

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…

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)

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 s…

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

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 differen…

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

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 o…

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

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…

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

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 Alli…

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

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 req…

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

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…

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

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…

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

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 an…

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

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, a…

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

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,…

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

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 regul…

MCAZ condom and glove type approval and batch release

Product-specific

POTRAZ equipment type approval

Wireless / radio

RPAZ authorisation for radiation sources and irradiating devices

Radiation

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

US$ 100.00

Package amendment for a condom type or brand

US$ 50.00

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

3 working days

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

30 days

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

5 working days

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

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 paya…

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

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 t…

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

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…

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

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 o…

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

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 tra…

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

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

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…

No source-verified answer is published for this dimension yet.

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

statement: MCAZ's Strategic Plan 2026 2030 lists among the Pharmacovigilance and Clinical Trials Division's functions 'Pharmacovigilance (PV) (safety monitoring of medicines, vaccines & med…

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

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…

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

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, o…

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

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, exer…