PMRA current fee schedule, reviewed for 2026, in MWK / USD.
24 fee lines100% exact amountscurrencies MWK / USDFX rates 2026-10-28reviewed 2026-10-28
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Class I device registration — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 150,000 | $86.03 | Per applicable product event | Verified |
| Class I device registration — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 700 | $700 | Per applicable product event | Verified |
| Class I device renewal or reregistration — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 100,000 | $57.36 | Per applicable product event | Verified |
| Class I device renewal or reregistration — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 500 | $500 | Per applicable product event | Verified |
| Class I device retention — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 100,000 | $57.36 | Per applicable product event | Verified |
| Class I device retention — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 300 | $300 | Per applicable product event | Verified |
| Class II device registration — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 500,000 | $287 | Per applicable product event | Verified |
| Class II device registration — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 1,000 | $1,000 | Per applicable product event | Verified |
| Class II device renewal or reregistration — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 300,000 | $172 | Per applicable product event | Verified |
| Class II device renewal or reregistration — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 700 | $700 | Per applicable product event | Verified |
| Class II device retention — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 200,000 | $115 | Per applicable product event | Verified |
| Class II device retention — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 400 | $400 | Per applicable product event | Verified |
| Class III device registration — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 1,000,000 | $574 | Per applicable product event | Verified |
| Class III device registration — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 1,700 | $1,700 | Per applicable product event | Verified |
| Class III device renewal or reregistration — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 800,000 | $459 | Per applicable product event | Verified |
| Class III device renewal or reregistration — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 1,000 | $1,000 | Per applicable product event | Verified |
| Class III device retention — made in malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | MWK 500,000 | $287 | Per applicable product event | Verified |
| Class III device retention — made outside malawi First Schedule 7(a) registration/renewal or 8(a) retention. Local registration application charges exclude additional sample-collection costs (note 4). | USD 1,000 | $1,000 | Per applicable product event | Verified |
| Post-registration notification — made in malawi First Schedule 9: the applicable category must be determined separately; the tariff alone does not classify a particular change. | MWK 100,000 | $57.36 | Per change application | Verified |
| Post-registration notification — made outside malawi First Schedule 9: the applicable category must be determined separately; the tariff alone does not classify a particular change. | USD 150 | $150 | Per change application | Verified |
| Post-registration minor variation — made in malawi First Schedule 9: the applicable category must be determined separately; the tariff alone does not classify a particular change. | MWK 150,000 | $86.03 | Per change application | Verified |
| Post-registration minor variation — made outside malawi First Schedule 9: the applicable category must be determined separately; the tariff alone does not classify a particular change. | USD 200 | $200 | Per change application | Verified |
| Post-registration major variation — made in malawi First Schedule 9: the applicable category must be determined separately; the tariff alone does not classify a particular change. | MWK 250,000 | $143 | Per change application | Verified |
| Post-registration major variation — made outside malawi First Schedule 9: the applicable category must be determined separately; the tariff alone does not classify a particular change. | USD 500 | $500 | Per change application | Verified |
Government fees only — service and testing costs are separate- Government Notice 27 of 2026, effective 1 April 2026, First Schedule 7(a), 8(a), 9 and notes 4-5.
- Headline low/high amounts cover initial imported Class I and Class III device registration only. Locally manufactured products are priced separately in MWK; Class II, renewals, retention and changes are separate detail rows.
- Sample-collection costs for local registration and other applicable services are additional. These charges do not establish an IVD-specific tariff or a four-class risk scheme.
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Exact amounts verified against the PMRA fee schedule · full review 2026-10-28 · row IDs are stable — cite as government-fees:malawi:i-registration-made-in-malawi