Pure Global AI
SAHPRA · structured requirements

🇿🇦 South Africa medical device regulatory data

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

51 facts23 dimensions14 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

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

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Advertisement content rules

advertising.content-rules
Fact-level verified

An advertisement may not contain a statement deviating from, conflicting with or going beyond the evidence accepted by the Council in the registration application and incorporated into the approved instructions for use; a written advertisement must contain the device name and, for a registered device, its registration number.

Conditions
  • Claims must align with approved evidence and IFU.
  • Registration number requirement applies to registered devices once registration is in force.

Offences: contravening the advertising regulation is punishable by a fine or imprisonment up to 10 years (reg 19(1)(f)).

Public advertising class restriction

advertising.public-audience-restriction
Fact-level verified

Only Class A and Class B medical devices and IVDs may be advertised to the public or a lay person; despite this, male or female condoms may be advertised to the public.

Conditions
  • Class C and Class D devices may only be advertised to professionals.
  • When a Class C/D device is advertised for the first time to a prospective user, written information at least equal to the IFU content must be given simultaneously (reg 21(1)(e)).

Gazette OCR text ('Class 8' is an OCR artifact for Class B).

Approval validity & renewal

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

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Expiry or lapse consequence

authorization.lapse
Fact-level verified

If the licence expires, the applicant is prohibited from trading; late renewal submissions are refused and a new application is required.

Conditions
  • Applies once the licence expiry date has passed.

Confirms baseline lapse fact on an official SAHPRA page.

Renewal deadline

authorization.renewal
Fact-level verified

An application for renewal of an establishment licence must contain the required information, be accompanied by the prescribed fee, and be made at least 90 days before expiry of the existing licence; SAHPRA states renewal applications submitted less than 90 days prior to expiry will not be accepted and a new application is then required.

Conditions
  • Renewal fee per the 2025 fee schedule: manufacturer R22,900; distributor R13,160; wholesaler R13,100.

FAQ: 'The license renewal application must be submitted at least 90 days prior to the license expiry date.'

Authority & regime

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

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Competent authority

authority.competent-authority
Fact-level verified

SAHPRA (South African Health Products Regulatory Authority), through its Medical Devices Unit, is the national authority regulating the licensing of medical device establishments and the registration of medical devices (IVD and non-IVD) in South Africa.

Conditions
  • Applies to all device classes.
  • SAHPRA also oversees radiation control under the Hazardous Substances Act 15 of 1973.

SAHPRA was enabled by the Medicines and Related Substances Act 101/1965 as amended (Amendment Acts 72/2008 and 14/2015).

Radiation-emitting device authority overlay

authority.radiation-control-mandate
Fact-level verified

SAHPRA Radiation Control licenses radiation-emitting devices under the Hazardous Substances Act 15 of 1973: electronic generators of ionising radiation (Group III, Regulation R1332 of 1973) such as X-ray equipment, linear accelerators and cyclotrons; radioactive sources above 4 kBq (Group IV, Regulations R246 and R247 of 1993); and listed electronic products (Regulation R1302 of 1991) including MRI systems and Class 3B/4 lasers.

Conditions
  • Applies in parallel to the medical-device establishment licence.
  • Import licence holders for listed electronic products must be permanently resident in South Africa.

The page also states listed electro-medical devices must comply with the EU Medical Device Directive (or its successors).

Change control

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

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Change notification and amendment

change.available-outcomes
Fact-level verified

A licensee must notify the Registrar in writing of any change to the particulars furnished in the application or entered in the register occurring after issue of the licence (Regulation 5(7)); licence amendments are handled under the SAHPRA amendment process (MD10-2025/26) with an amendment fee of R5,500, and product-list updates are notified separately (MD09-2025/26).

Conditions
  • Amendment applications must include the updated product listing including all previously approved products.
  • Significant device modifications constitute a 'modification' requiring their own application under reg 8(8) once registration applies.

Confirms baseline change-control fact; regulation text also verified directly in the gazette.

Product list update

change.product-list-update
Fact-level verified

Updates to the product list(s) of a licensed establishment are notified to SAHPRA under Regulation 5(7) as a separate notification process (SAHPRA MD09-2025/26), keeping the licence's device listing current.

Conditions
  • Notification-based for product additions/changes to a licensed establishment's listing.

Page quote: 'Regulation 5(7) ... makes provision for the amendment of a medical device establishment licence.'

Clinical investigation & performance

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

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Clinical investigation authorisation

clinical.prior-authorisation
Fact-level verified

A person may not conduct a clinical investigation, clinical trial or clinical performance assessment for an IVD without Council authorisation; the investigator must be appropriately qualified, approved by the Council and resident in the Republic, the study must follow good clinical practice guidelines determined by the Council, progress reports are due every six months and 30 days after completion or termination, and adverse event reports immediately or as soon as practically possible; investigational devices must be labelled 'for investigational use only'.

Conditions
  • Application on GLF-MD-17A, fee R33,700 (clinical trial application, safety and efficacy, GG 52106 item 7(a)(i)).

Gazette OCR text; form and fee verified on SAHPRA forms page and fee gazette.

Device definition & scope

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

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IVD definition

definition.ivd
Fact-level verified

Under Regulation 1 of GN R1515/2016, an IVD ('in-vitro diagnostic') means a medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.

Conditions
  • IVDs are regulated together with medical devices under the same regulations.

Gazette OCR text.

Medical device definition

definition.medical-device
Fact-level verified

Under section 1 of Act 101/1965, a 'medical device' is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article (including Group III and IV Hazardous Substances under Act 15/1973), intended by the manufacturer for diagnosis, prevention, monitoring, treatment or alleviation of disease, and related purposes, which does not achieve its primary intended action by pharmacological, immunological or metabolic means (but may be assisted by such means).

Conditions
  • Software is explicitly within scope.
  • Includes Group III and IV hazardous substances (radiation-emitting devices and radioactive sources).

Definition substituted by s1(g) of Act 72/2008 and s1(h) of Act 14/2015.

Research-use-only IVD borderline

definition.ruo-ivd-borderline
Fact-level verified

A 'research use only IVD' (RUO IVD) is defined as an IVD labelled for 'research use only' and 'investigational use only' and may not be used for clinical diagnostic purposes; combination devices (device incorporating a medicine as an integral part with ancillary action) and custom made devices are separately defined with their own rules.

Conditions
  • RUO labelling restricts clinical diagnostic use.
  • Combination devices must declare scheduled/biological substances on the label (reg 22(1)(f)).

Gazette OCR text.

Dossier requirements

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

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Licence application content

dossier.licence-application-content
Fact-level verified

An establishment licence application is made on a form approved by the Council and must include documentary proof of the particulars of the owner of the business, the particulars of the authorised representative, certification to a Quality Management System as determined by the Council, specification of the devices (or groups/families) to be manufactured/imported/exported/distributed, and the application fee.

Conditions
  • The Registrar may request additional documentation within a specified reasonable time (reg 5(2)).
  • The Council may inspect the business premises (reg 5(3)).

SAHPRA FAQ adds: signed cover letter to the CEO (attention Medical Device Unit), application form in Excel plus initialed PDF, authorised representative CV, quality manual (or Site Master File for wholesalers) and proof of payment.

Registration application content

dossier.registration-application-content
Fact-level verified

A device/IVD registration application (when called up) must be in English, on the appropriate form, accompanied by the proposed label, the instructions for use, a copy of the manufacturer or distributor licence with a QMS conformity assessment certificate, a certified copy of the conformity assessment certificate for the device issued by a Conformity Assessment Body, a declaration of conformity, and the application fee; where the device is registered abroad, a certified copy of the foreign certificate of registration or premarket approval must accompany the application. Applications are per individual device, group/family or modification.

Conditions
  • Applies once registration call-up notices are in force.
  • Device must comply with the Essential Principles of Safety and Performance (reg 8(6)).

Gazette OCR text. Reg 8(4): 'The information referred to in sub-regulation (3) must, at least, be in English.'

Economic-operator roles

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

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Authorised representative role

market-entry.local-role
Fact-level verified

An 'authorised representative' is a natural person, resident in South Africa, holding a written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider, in whose name the manufacturer licence, distributor licence, wholesaler licence or certificate of registration is issued, and who is responsible for all aspects of the device including performance, quality, safety and compliance with conditions of registration.

Conditions
  • Must reside in South Africa.
  • One authorised representative may act for more than one company only where companies share an address/province or regulatory oversight sits at head office (SAHPGL-MD-07 s3.7.1).

Confirms the baseline archetype: a responsible natural person, not the EU AR legal-entity archetype.

Representative or holder change

market-entry.representative-change
Fact-level verified

Changes to licence particulars (including the authorised representative) after issue of the licence require written notification to the Registrar under Regulation 5(7) and are processed as establishment-licence amendments (SAHPRA MD10-2025/26 process); the amendment fee is R5,500.

Conditions
  • No product registration transfer is involved while product registration is not yet called up.

Confirms baseline representative-change fact; SAHPRA process document MD10-2025/26 (27 Jan 2026).

Manufacturer, distributor and wholesaler definitions

roles.operator-definitions
Fact-level verified

Under Regulation 1 GN R1515: a 'manufacturer' is the natural or legal person responsible for design, manufacture, packaging and labelling before placing on the market under their own name (regardless of whether operations are outsourced), or any person who assembles, packages, reprocesses, refurbishes or labels ready-made products or assigns their intended purpose; a 'distributor' imports or exports a registered device in its final form and places it on the market under its own name and sells to healthcare professionals, institutions, wholesalers or users; a 'wholesaler' purchases from a manufacturer or distributor and sells to a retailer.

Conditions
  • Persons who only assemble or adapt devices already on the market to their intended purpose for patients are excluded from 'manufacturer'.

Gazette OCR text.

Establishment, import & distribution

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

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Import permit requirements (2026 amendment)

import.import-permit-requirements-2026
Fact-level verified

An amendment to Regulation 6 of the General Regulations under Act 101/1965, published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026, expanded the ports of entry for import and export of health products and introduced requirements relating to import permits.

Conditions
  • Published for implementation on 7 August 2026; SAHPRA notice of correction dated 12 August 2026.

Effective from 2026-08-07

Gazette full text hosted on SharePoint; verified via SAHPRA's official notice page.

Licence required to trade

import.no-licence-no-trade
Fact-level verified

No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA establishment licence; acknowledgement letters stopped being accepted as of 31 March 2020.

Conditions
  • Subject to the Class A non-sterile, non-measuring exemption (position statement 9.106).

A 2017 gazette notice requested manufacturers and distributors to apply within 6 months (wholesalers 12 months).

Designated ports of entry

import.ports-of-entry
Fact-level verified

A person may not import a medical device or IVD into the Republic except through designated ports of entry: Cape Town International Airport or harbour, Port Elizabeth Airport or harbour, King Shaka International Airport or Durban harbour, or OR Tambo International Airport; used devices may be imported by a manufacturer only for service, repair, refurbishing or maintenance.

Conditions
  • Baseline list under Regulation 3(1)-(2) GN R1515; expanded by the 7 August 2026 amendment to the General Regulations (GG 55152, Notice 7780).

Gazette OCR text.

Import of unregistered devices

import.unregistered-import-authorisation
Fact-level verified

A person may only import a medical device or IVD if licensed under section 22C(1)(b) to import, and, in the case of unregistered devices, if authorised by the Council to import the unregistered device; devices transmitted through the Republic must be stored in a bonded warehouse registered with the Council and not be manipulated unless authorised.

Conditions
  • Bonded warehouse must comply with storage conditions determined by the Council.

Gazette OCR text.

Fees

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

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Retention fee and revocation rule

fees.retention-revocation-rule
Fact-level verified

An annual licence retention fee (R4,400 under the 2025 fee regulations) is payable in respect of a licence issued under section 22C(1)(b) on or before the last working day of June each year, failing which the licence may be revoked.

Conditions
  • Retention fees apply per licence where multiple licences are held.
  • Payable notwithstanding the five-year validity period (regulation 5(6) GN R1515).

Fee gazette scanned; text recovered by OCR.

Label, IFU & language

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

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Instructions for use language

ifu.language-and-content
Fact-level verified

The instructions for use of a medical device must contain the prescribed information in at least English (reg 23(1)); the IFU of an IVD must likewise be in at least English and must be included with the sale of each IVD, except that IFUs for Class A IVDs must be included only where applicable (reg 24).

Conditions
  • IFU content includes residual risks, contraindications, specifications, and for IVDs analytical/clinical performance characteristics and metrological traceability of calibrators.

Gazette OCR text.

Label particulars and language

label.particulars-english
Fact-level verified

The label of each medical device or IVD must contain: name/trade name, product description and intended use, catalogue code (where applicable), name and business address of the manufacturer and of the holder of the certificate of registration, scheduled/biological substance indication, lot number, serial number (control number for accessories, version number for software), expiry date (or manufacturing date), special storage/handling conditions, sterile state and sterilisation method, net quantity, warnings/precautions, and indications for single use, clinical investigation, non-clinical research, presentation, IVD use, or professional/near-patient/point-of-care/self-testing; the label must be in at least English and appear on the device itself or the packaging of each unit and of multiple devices.

Conditions
  • Reprocessed devices must state the re-processor's name and be identified as reprocessed.
  • Individual reagents/articles in IVD kits that are separate devices must each comply.

Gazette OCR text.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Post-market safety duties

pms.safety-duties
Fact-level verified

The authorised representative or holder of a certificate of registration must, within Council-determined time frames, inform the Council of steps taken to address adverse events; on Council request conduct a concise critical analysis of safety and performance and submit the results within a specified time frame; where safety concerns are confirmed, submit case reports, usage figures, periodic safety update reports and performance studies; and keep and maintain (or have access to) records of adverse event data for their devices.

Conditions
  • Duties sit with the authorised representative/licence holder and registration certificate holder.
  • Trend changes in normally exempt events lift the reporting exemption (SAHPGL-MD-03 s4.3.2).

SAHPGL-MD-03 s4.3: exempt events must still be documented with reasons for non-reporting retained on record.

Official forms & portals

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

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Current application forms

forms.current-list
Fact-level verified

Current SAHPRA medical device forms: GLF-MD-06A 'Licence Application Medical Device Manufacture'; GLF-MD-06B 'Licence Application Medical Device Wholesaler Form'; GLF-MD-06C 'Licence Application to Import Distribute or Export Medical Devices'; GLF-MD-11A 'Medical Device Adverse Event Reporting Form'; GLF-MD-17A 'Application for Clinical Investigation of Medical Devices'; GLF-MD-21A 'Application for Certificate of Free Sale for Medical Devices'; GLF-MD-25A 'Application to Import Section 21 Ruo Medical Devices Including IVDs'.

Conditions
  • Versions as displayed on the SAHPRA forms page (updates Feb 2025 - Jun 2026).

Licence application forms are completed in Microsoft Excel with formatting restricted; a signed/initialed PDF is also submitted.

Submission channel

forms.submission-channel
Fact-level verified

The cited SAHPRA guidance directs establishment licence applications to mdadmin@sahpra.org.za, with mdcovid@sahpra.org.za copied for applications including COVID-19 testing kits; vigilance reports go to mdvigilance@sahpra.org.za and recalls to recalls@sahpra.org.za.

Conditions
  • Email-based submission current as of the checking date.

Enquiries to mdenquiries@sahpra.org.za; general enquiries enquiries@sahpra.org.za.

QMS, audit & inspection

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

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ISO 13485 requirement

qms.iso-13485-requirement
Fact-level verified

Applicants must submit an ISO 13485 accreditation certificate or confirmation letter issued by a conformity assessment body recognised by SAHPRA; the requirement applies to manufacturers and distributors and is being phased in (Phase 3 in effect, voluntary confirmations to mdqueries@sahpra.org.za), with evidence required on licence renewal; wholesalers are not required to submit ISO 13485 certification, and the requirement applies even to establishments exempted from licensing.

Conditions
  • Applies to manufacturers and distributors (importers/exporters).
  • Not required for wholesalers.
  • Applies even to licence-exempt Class A establishments.

Regulation 5(4) requires the authorised representative to provide certified evidence of QMS certification. SAHPGL-MD-07 s3.4.4: 'The ISO 13485 needs to be submitted by manufacturers and distributors, and it will be compulsory upon communication from SAHPRA.'

Recall, FSCA & market surveillance

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

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Field Safety Corrective Action reporting

recall.fsca-report
Fact-level verified

The holder of a certificate of registration or licensee must submit a Field Safety Corrective Action report to the SAHPRA Medical Device Unit when correcting product already on the market, removing product from the market to facilitate corrections, or advising users of an issue relating to a medical device; FSCA notifications go to mdvigilance@sahpra.org.za.

Conditions
  • Applies to licence holders and registration certificate holders.

Regulation 18 additionally allows Council investigation where a device is recalled in South Africa or any other country or an international alert exists.

Recall notification channel

recall.recall-notification-channel
Fact-level verified

Recalls must be communicated to recalls@sahpra.org.za (Regulatory Compliance Unit) and must NOT be communicated to the Medical Device Unit; SAHPRA publishes recall notices for medical devices.

Conditions
  • Separate from FSCA/adverse-event reporting to the Medical Device Unit.

SAHPRA's document archive publishes classified recall notices (e.g. Class I Type B, August 2026).

Registration pathways

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

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Class A licensing exemption

pathway.class-a-licensing-exemption
Fact-level verified

Manufacturers, distributors and wholesalers of non-sterile, non-measuring Class A medical devices are exempt from the establishment licensing requirement, per SAHPRA position statement 9.106; however the ISO 13485 requirement still applies even where the establishment is exempted from licensing.

Conditions
  • Class A devices that are sterile or have a measuring function are NOT exempt.
  • Exempted establishments remain subject to the ISO 13485 submission requirement per the licensing FAQ.

FAQ cross-reference: 'the requirement is applicable even in cases where the establishment is exempted from licensing'.

Establishment licence types

pathway.establishment-licence-types
Fact-level verified

Before commencing business, a manufacturer, wholesaler or distributor of medical devices/IVDs must apply for: (aa) a manufacturer licence to manufacture, import or export; (bb) a distributor licence to import, export and distribute; or (cc) a wholesale licence to act as wholesaler, and must appoint an authorised representative residing in South Africa.

Conditions
  • Applies to all medical devices and IVDs unless exempted.
  • A company can hold more than one licence type per site (retention fees payable per licence).

SAHPRA's unit page confirms the three licence types are currently the operative market-entry control.

IVD listing evidence requirement

pathway.ivd-listing-evidence
Fact-level verified

For licence applications listing COVID-19, HIV and Mpox IVDs, applicants must provide evidence of premarket registration from one of the six jurisdictions recognised by SAHPRA, plus the OEM's ISO 13485 certificate and a technical dossier.

Conditions
  • Applies to COVID-19, HIV and Mpox IVD listings.
  • Applies in addition to the establishment licence itself.

The six recognised jurisdictions are listed in SAHPGL-MD-07 v4: Australia, Brazil, Health Canada, Europe, Japan, USFDA.

Product registration status

registration.status-development
Fact-level verified

The registration process for medical devices is still in development; a Registration Call-Up Plan will be published setting out the phased approach in which devices will be called up by type and class. Under Regulation 11(2), devices (except custom made) must be registered in terms of call-up notices before being sold or used, and unregistered devices lawfully sold at commencement remain legal until their call-up period expires (reg 28(1)).

Conditions
  • Current operative control is establishment licensing plus product listing.
  • No general device registration call-up is in force as of the checking date.

Regulation 11(2) GN R1515: 'Medical devices, except custom made medical devices, and IVDs must be registered with the Council in terms of call up notices before they may be sold or used in the Republic.'

Reliance & recognition

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

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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.

South Africa 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 South Africa (7 records)

South AfricaNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference
Pending verification
Statement

SAHPRA recognises six jurisdictions for premarket evidence: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification. Establishment-licence applications must annex 'Evidence of premarket registration from one of the 6 jurisdictions recognised by SAHPRA', and Certificate of Free Sale applications for Class C and D devices must show pre-market approval/registration or emergency-use authorisation from at least one of the six or WHO PQ. China NMPA is not one of the six, so an NMPA-only Chinese device cannot satisfy the Class C/D evidence requirement.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

south-africa

China Classes In Scope

NMPA Class II/III certificates; target South Africa Class C and D devices and IVDs (licence listing and Certificate of Free Sale)

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Class C and D devices/IVDs listed in a CFS application (3.1.28).
  • ISO 13485 certification of the original manufacturer and a declaration of conformity with the Essential Principles are also required.
  • CFS processed within 15 days; valid at most one year.
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2025-05-21

Source passage: For medium to high risk (Class C) and high risk (Class D) medical devices listed in the Certificate of Free Sale application: o Evidence of pre-market approval/registration/evidence of emergency use authorisation for each listed medical device/s from at least one of the six jurisdictions recognised by SAHPRA (Australia, Brazil, Health Canada, Europe, Japan, USFDA) or pre-qualification by the World Health [Organization] o Evidence of ISO13485 certification of the original manufacturer

South AfricaNMPA

Regulatory reference

China NMPA approval: outside SAHPRA reliance-guideline recognised authorities

reliance.china-nmpa-not-reference-reliance-guideline
Pending verification
Statement

SAHPRA's Medical Devices Reliance Guideline (SAHPGL-MD-22 v1, 25 February 2026; consulted as the November 2025 consultation text SAHPGL-MD-19_v1) grants abridged review only to devices already approved by a Recognised Regulatory Authority with which SAHPRA aligns (list to be published on SAHPRA's agreements/MoUs page), by a WHO Listed Authority (WHO permanent WLA list), under WHO CRP/PQ/EUL, or under the AMA continental procedure; a device without prior approval from any listed recognised authority goes to the full evaluation route. China NMPA is neither on the WHO WLA list nor named as an RRA, and SAHPRA's agreements page currently lists no China arrangement.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

south-africa

China Classes In Scope

NMPA Class II/III certificates; target Class B, C and D product registration and licence listing (reliance pathways)

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Verification of sameness with the product approved by the reference authority is mandatory under every reliance pathway.
  • Not applicable to Class A non-sterile/non-measuring devices or emergency-use registrations.
  • MDSAP audit reports and locally recognised CAB ISO 13485 audits are recognised for QMS.
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2026-02-25

Source passage: A medical device that has not obtained any prior approval from any of the listed medical device recognised regulatory authorities at the point of application will be subject to the full evaluation route. [...] i) RECOGNISED REGULATORY AUTHORITIES An application must have been approved by one or more of the RRAs with which SAHPRA aligns itself. The list of RRA is available on the SAHPRA website. [...] iv) WHO Listed Authority (WLA) https://www.who.int/publications/m/item/list-of-who-listed-authorities-wlas

South AfricaWHO

Regulatory reference

WHO Collaborative Registration Procedure for IVDs

reliance.who-crp-ivds
Fact-level verified

SAHPRA applies the WHO Collaborative Registration Procedure (CRP) for IVDs, covering new product registration and post-registration amendments for IVDs, per the SAHPRA Medical Devices page.

Conditions
  • Applies to WHO-prequalified IVDs.
  • National requirements and fees remain.

Confirms the existing WHO PQ-to-CRP reliance edge on an official SAHPRA page.

South AfricaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority

CE Mark (EU MDR)

Accepted

Yes

Benefit

A CE certificate is the technical dossier and QMS evidence SAHPRA works from on the reliance pathways.

Timeline Savings

None published

SAHPRA MD019 v1 (22 July 2020) — processing of medical device establishment licence applications: 6-8 weeks, expedited pathway 10-15 working days, observation-letter responses in 10 working days (2 on the expedited route), maximum two response cyclesSAHPRA Questions & Answers: License Renewal v1 (4 February 2022) — renewal filed at least 90 days before expiry, processing takes at least 4-8 weeks, annual retention fees applySAHPRA Medical Devices Reliance Guideline (SAHPGL-MD-19 v1, effective 31 October 2025) — reliance pathways for establishment listing, Class B/C/D product registration, ISO 13485 audits and clinical trials; publishes no processing periodsSAHPRA FAQs — medical device establishment licence processed in 6-8 weeks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

South AfricaSource authority not specified

Prior approval / evidence record

Recognised regulatory authority (reliance guideline)

Authority

Recognised regulatory authority (reliance guideline)

Accepted

Yes

Benefit

Prior approval by a recognised authority is what makes the abridged, recognition, work-sharing and verification pathways available at all, and a device without one falls out of reliance into full evaluation. What it does not buy is a shorter clock, because SAHPRA has not published one for either route.

Timeline Savings

None published — neither the reliance pathways nor full evaluation carries a period

SAHPRA MD019 v1 (22 July 2020) — processing of medical device establishment licence applications: 6-8 weeks, expedited pathway 10-15 working days, observation-letter responses in 10 working days (2 on the expedited route), maximum two response cyclesSAHPRA Questions & Answers: License Renewal v1 (4 February 2022) — renewal filed at least 90 days before expiry, processing takes at least 4-8 weeks, annual retention fees applySAHPRA Medical Devices Reliance Guideline (SAHPGL-MD-19 v1, effective 31 October 2025) — reliance pathways for establishment listing, Class B/C/D product registration, ISO 13485 audits and clinical trials; publishes no processing periodsSAHPRA FAQs — medical device establishment licence processed in 6-8 weeks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

South AfricaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

A US clearance or approval serves the same role as a recognised-authority approval on the reliance pathways.

Timeline Savings

None published

SAHPRA MD019 v1 (22 July 2020) — processing of medical device establishment licence applications: 6-8 weeks, expedited pathway 10-15 working days, observation-letter responses in 10 working days (2 on the expedited route), maximum two response cyclesSAHPRA Questions & Answers: License Renewal v1 (4 February 2022) — renewal filed at least 90 days before expiry, processing takes at least 4-8 weeks, annual retention fees applySAHPRA Medical Devices Reliance Guideline (SAHPGL-MD-19 v1, effective 31 October 2025) — reliance pathways for establishment listing, Class B/C/D product registration, ISO 13485 audits and clinical trials; publishes no processing periodsSAHPRA FAQs — medical device establishment licence processed in 6-8 weeks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

South AfricaAustralia TGA · Health Canada · Japan MHLW / PMDA · Brazil ANVISA · WHO

Regulatory reference

Recognised reference jurisdictions

reliance.recognised-jurisdictions
Fact-level verified

SAHPRA recognises six reference jurisdictions for reliance purposes: Australia, Brazil, Health Canada, Europe, Japan and USFDA, plus WHO prequalification of IVDs. For Class C and D devices listed in Certificate of Free Sale applications, evidence of pre-market approval/registration or emergency use authorisation from at least one of the six jurisdictions (or WHO PQ) is required.

Conditions
  • Used for Class C and Class D medical devices and IVDs.
  • SAHPRA retains the final decision based on South African regulations.

The SAHPRA Medical Devices page confirms reliance pathways will use registrations in these recognised jurisdictions or WHO PQ.

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Applicant deficiency response deadline

clocks.deficiency-response-2-working-days
Fact-level verified

An applicant receiving an observation letter on deficiencies in a medical device establishment licence application is required to respond within 2 working days; overall processing timelines depend on timeous applicant responses.

Conditions
  • Applies to establishment licence applications under SAHPRA's current process.

Stop-clock style rule: the 6-8 week processing time depends on applicant response time.

Special access & derogation

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

Compare countries

Custom made device regime

special.custom-made-devices
Fact-level verified

Custom made medical devices (made per a written prescription/order for the sole use of a particular user, excluding mass-produced adapted devices) are exempt from registration (reg 11(2)) but must be manufactured and sold in compliance with the guidelines applicable to medical devices (reg 25), with permanent order/traceability records (reg 26).

Conditions
  • Definition requires specific design characteristics and sole use by a particular user.

Gazette OCR text.

Section 21 unregistered product authorisation

special.section-21-authorisation
Fact-level verified

Under section 21 of Act 101/1965, the Authority may in writing authorise any person to sell, during a specified period, to any specified person or institution a specified quantity of a particular unregistered medicine, medical device or IVD; use is restricted to the purposes, manner and period determined by the Authority, and the authorisation can be withdrawn at any time.

Conditions
  • Written authorisation per product, quantity, recipient and period.
  • SAHPRA form GLF-MD-25A 'Application to Import Section 21 RUO Medical Devices Including IVDs' applies to RUO imports under this route.

Section 36 of the Act separately allows applications for exemption from any provision of the Act (SAHPGL-MD-07 s3.1.25).

Submission communications & appeal

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

Compare countries

Appeal process

appeal.30-days
Fact-level verified

A person aggrieved by a decision of the Council may lodge a written appeal within 30 days of being notified of the decision, to the Chairperson of the Council for attention the Registrar; the Registrar must within 30 days meet the appellant to try to resolve the matter, failing which the appellant may within 30 days (on payment of the prescribed fee) request the Minister to convene an appeal committee, which must decide within 30 days of its first hearing.

Conditions
  • Notice of appeal must set out the basis clearly and succinctly.
  • Legal representation is permitted before the appeal committee.

Appeals are contemplated in section 24 of the Act. Gazette OCR text.

UDI, listing & traceability

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

Compare countries

Device listing on licence

listing.devices-on-licence
Fact-level verified

A licence application must specify, as determined by the Council, the medical devices or IVDs (or group or family) to be manufactured, imported, exported or distributed and sold; the licensed product list is maintained through update notifications, and the device register (once registration is called up) records the registration number, class, holder, original manufacturer and nomenclature system code (GMDN-based).

Conditions
  • Product listing applies to all licences; the register entries apply once registration call-up occurs.

Implantable and custom-made record retention

traceability.implant-record-retention
Fact-level verified

A permanent record of Class D implantable and high-risk custom-made devices sold to patients must be kept on the premises of the healthcare institution/professional (patient identity, device model/batch/serial, user, manufacturer) and retained by the seller for at least five years beyond the expected life of the device; manufacturers, distributors or wholesalers of Class D or implantable custom-made devices must keep invoice records (date, product, purchaser, quantities, batch/serial) for fifty years from the date of sale.

Conditions
  • Applies to Class D implantable devices and high-risk custom-made devices.

Gazette OCR text.

Vigilance & incident reporting

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

Compare countries

Reporting channel and form

vigilance.reporting-channel
Fact-level verified

All reportable adverse events (regulation 17 duties of the authorised representative and holder of a certificate of registration) must be submitted on the Medical Device Adverse Event Reporting Form (GLF-MD-11A) to mdvigilance@sahpra.org.za; users may also report events to the licensee, manufacturer, authorised representative or the Council.

Conditions
  • Licensees/HCRs are the obligated reporters.
  • Anyone may report an adverse event (reg 17(3)).

Document dated 24 June 2026, signed by the SAHPRA CEO.

Death or serious deterioration deadline

vigilance.timeline-10d-death-serious-injury
Fact-level verified

10

Conditions
  • Calendar days after awareness.
  • Event leading to death or serious deterioration in the state of health of a patient, user or other person.

If uncertain whether an event is reportable, a report must be submitted within the timeframe for that event type.

Recurrence-risk event deadline

vigilance.timeline-30d-recurrence-risk
Fact-level verified

30

Conditions
  • Days after awareness.
  • Event whose recurrence might lead to death or serious deterioration in health.

Clinical-study timelines: 48 hours for serious health threats to the study population, 10 days for USADE/death events, 30 days for other serious events (s4.5).

Related structured datasets

Classification systems · 1 record
Open Risk classes A through D. →
Id

south-africa:medical-device

Jurisdiction Id

south-africa

Domains
  • medical-device
  • ivd
Name

Risk classes A through D.

Classes
  • Id

    a

    Label

    Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D

    Normalized Risk Level

    highest

Regulator

SAHPRA

Official Domains
  • sahpra.org.za
Source Status

official-source-verified

Source Title

SAHPRA SAHPGL-MD-04 v5 — Guideline for Classification of Medical Devices and IVDs (Regulation 11(1), GN R1515)

Source Url

https://www.sahpra.org.za/wp-content/uploads/2025/03/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
  • ivd-class-axis
  • ivd-classification-rules
Notes
  • Regulation 11(1) GN R1515 (GG 40480): Class A low, B low-moderate, C moderate-high, D high, where risk relates to the patient, user or public health; SAHPGL-MD-04 v5 (27 Feb 2025) supplies the technical classification rules.
  • Classification is the manufacturer's/distributor's responsibility using SAHPRA-supplied rules based on intended use, risk, invasiveness and duration; where inconclusive or between classes the higher class applies (reg 11(4)); groups/systems/procedure packs take the highest classification of any component; accessories are classified separately.
  • IVD technical rules: self-testing IVDs Class C unless otherwise specified; specified high-risk purposes/markers Class D; certain listed IVDs Class A; any IVD not mentioned in rules 1-7 defaults to Class B.
Registration pathways, prior approvals and planning · 1 record
Open South Africa registration →
Country

South Africa

Jurisdiction Id

south-africa

Country Code

ZA

Flag

🇿🇦

Regulator

South African Health Products Regulatory Authority

Regulator Abbrev

SAHPRA

Region

africa

Tier

3

Risk Classification

4-class (A, B, C, D) — EU-aligned (licence-based system)

Classes
  • Id

    establishment-licence

    Class Name

    Medical device establishment licence

    Pathway

    SAHPRA establishment licensing

    Official Timeline
    Min

    6

    Max

    8

    Unit

    weeks

    Realistic Timeline
    Min

    2

    Max

    4

    Unit

    months

    Notes
    • SAHPRA communication MD019 §3: establishment licence applications are processed within 6-8 weeks, and the same figure is repeated in the licensing FAQ
    • An expedited pathway aiming to conclude within 10-15 working days exists but is scoped to devices and IVDs required during the COVID-19 pandemic under MD005, so it is not generally available
    • The clock is conditional on the applicant: a deficiency observation letter must be answered within 10 working days on the standard route or 2 working days on the expedited one, only two response cycles are permitted, and a third round or a missed deadline ends the licensing process with no recommendation
    • One clock covers the whole route and it does not vary by device class
    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    SAHPRA MD019 v1 (22 July 2020) — processing of medical device establishment licence applications: 6-8 weeks, expedited pathway 10-15 working days, observation-letter responses in 10 working days (2 on the expedited route), maximum two response cycles

    Url

    https://www.sahpra.org.za/wp-content/uploads/2020/07/MD019-Processing-of-licence-applications-v1-22072020.pdf

    Effective Date

    2020-07-22

    Accessed Date

    2026-08-30

  • Id

    establishment-licence-renewal

    Class Name

    Medical device establishment licence renewal

    Official Timeline
    Min

    4

    Max

    8

    Unit

    weeks

    Realistic Timeline
    Min

    2

    Max

    4

    Unit

    months

    Notes
    • SAHPRA licence-renewal Q&A §3.5: processing "may be for a period of at least 4 to 8 weeks", so the lower bound is a floor rather than a promise
    • The renewal application must be filed at least 90 days before the licence expiry date, and licensees whose licence had already lapsed at publication were given a grace period of up to 90 days
    • Product-list changes can ride along with the renewal without a separate amendment as long as the licensed device class does not change; address, company-name, activity, Class D additions and responsible-person changes are amendments that carry an extra fee and can only be filed after the renewed licence has been issued
    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    SAHPRA Questions & Answers: License Renewal v1 (4 February 2022) — renewal filed at least 90 days before expiry, processing takes at least 4-8 weeks, annual retention fees apply

    Url

    https://www.sahpra.org.za/wp-content/uploads/2022/02/License-Renewal-Q-and-A-to-support-communication-to-industry_Final.pdf

    Effective Date

    2022-02-04

    Accessed Date

    2026-08-30

Key Requirements
  • Local establishment (manufacturer, importer, distributor, or wholesaler) must hold a SAHPRA licence and appoint an authorised representative resident in South Africa
  • Product registration is no longer purely prospective: the Medical Devices Reliance Guideline effective 31 October 2025 sets out abridged, recognition, work-sharing and verification pathways for registering Class B, C and D devices and IVDs against the technical dossier guidelines, and SAHPRA ran a voluntary registration feasibility study in 2024
  • What registration still lacks is a clock. The reliance guideline publishes no processing period, and it points forward to a Guideline on Medical Device Registration Process that will carry the document requirements, so the step that will eventually decide market entry is currently unbounded
  • Class A non-measuring and non-sterile devices, and any device without prior approval from a recognised regulatory authority, fall outside the reliance route and face full evaluation
  • Certificate of Free Sale (CFS) issued within 15 days, valid 1 year
Prior Approvals
  • Authority

    Recognised regulatory authority (reliance guideline)

    Accepted

    Yes

    Benefit

    Prior approval by a recognised authority is what makes the abridged, recognition, work-sharing and verification pathways available at all, and a device without one falls out of reliance into full evaluation. What it does not buy is a shorter clock, because SAHPRA has not published one for either route.

    Timeline Savings

    None published — neither the reliance pathways nor full evaluation carries a period

  • Authority

    CE Mark (EU MDR)

    Accepted

    Yes

    Benefit

    A CE certificate is the technical dossier and QMS evidence SAHPRA works from on the reliance pathways.

    Timeline Savings

    None published

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    A US clearance or approval serves the same role as a recognised-authority approval on the reliance pathways.

    Timeline Savings

    None published

Local Rep Required

Yes

Local Rep Name

South African Licensed Establishment

Mdsap Accepted

Yes

Mdsap Benefit

Accepted as QMS evidence

Registration Validity

Each establishment licence carries its own expiry date printed on the licence; SAHPRA does not publish a single statutory term. Renewal must be filed at least 90 days before that date and annual retention fees are payable in the interim

Last Updated

2026-08-30

Verification Status

partially-verified

Reviewed On

2026-08-30

Official Sources
  • Title

    SAHPRA MD019 v1 (22 July 2020) — processing of medical device establishment licence applications: 6-8 weeks, expedited pathway 10-15 working days, observation-letter responses in 10 working days (2 on the expedited route), maximum two response cycles

    Url

    https://www.sahpra.org.za/wp-content/uploads/2020/07/MD019-Processing-of-licence-applications-v1-22072020.pdf

    Effective Date

    2020-07-22

    Accessed Date

    2026-08-30

  • Title

    SAHPRA Questions & Answers: License Renewal v1 (4 February 2022) — renewal filed at least 90 days before expiry, processing takes at least 4-8 weeks, annual retention fees apply

    Url

    https://www.sahpra.org.za/wp-content/uploads/2022/02/License-Renewal-Q-and-A-to-support-communication-to-industry_Final.pdf

    Effective Date

    2022-02-04

    Accessed Date

    2026-08-30

  • Title

    SAHPRA Medical Devices Reliance Guideline (SAHPGL-MD-19 v1, effective 31 October 2025) — reliance pathways for establishment listing, Class B/C/D product registration, ISO 13485 audits and clinical trials; publishes no processing periods

    Url

    https://www.sahpra.org.za/wp-content/uploads/2025/11/SAHGL-MD-19_v1-MEDICAL-DEVICES-RELIANCE-GUIDELINE-document-for-comment.pdf

    Effective Date

    2025-10-31

    Accessed Date

    2026-08-30

  • Title

    SAHPRA FAQs — medical device establishment licence processed in 6-8 weeks

    Url

    https://www.sahpra.org.za/faqs-medical-devices-licencing/

    Accessed Date

    2026-08-25

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 SAHPRA. Appoint a South African Licensed Establishment.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

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

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    SAHPRA 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. SAHPRA may issue questions.

    Duration

    6-8 weeks

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, SAHPRA issues South Africa market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open South Africa fees →
Jurisdiction Id

south-africa

Country

South Africa

Country Code

ZA

Authority

SAHPRA

Low Risk Local
Min

15600

Max

26200

Currency

ZAR

Per Product

No

High Risk Local
Min

15600

Max

26200

Currency

ZAR

Per Product

No

Details
  • Id

    new-establishment-licence-manufacturer

    Item

    New medical-device/IVD establishment licence - manufacturer

    Currency

    ZAR

    Amount Local

    26200

    Amount Local Formatted

    ZAR 26,200

    Frequency

    Per establishment licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    new-establishment-licence-distributor-wholesaler

    Item

    New medical-device/IVD establishment licence - distributor or wholesaler

    Currency

    ZAR

    Amount Local

    15600

    Amount Local Formatted

    ZAR 15,600

    Frequency

    Per establishment licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    renewal-establishment-licence-manufacturer

    Item

    Establishment-licence renewal - manufacturer

    Currency

    ZAR

    Amount Local

    22900

    Amount Local Formatted

    ZAR 22,900

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    renewal-establishment-licence-distributor

    Item

    Establishment-licence renewal - distributor

    Currency

    ZAR

    Amount Local

    13160

    Amount Local Formatted

    ZAR 13,160

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    renewal-establishment-licence-wholesaler

    Item

    Establishment-licence renewal - wholesaler

    Currency

    ZAR

    Amount Local

    13100

    Amount Local Formatted

    ZAR 13,100

    Frequency

    Per renewal

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    annual-licence-retention

    Item

    Annual establishment-licence retention

    Currency

    ZAR

    Amount Local

    4400

    Amount Local Formatted

    ZAR 4,400

    Frequency

    Annual, by the last working day of June

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    establishment-licence-amendment

    Item

    Establishment-licence amendment

    Currency

    ZAR

    Amount Local

    5500

    Amount Local Formatted

    ZAR 5,500

    Frequency

    Per amendment

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    licence-issuance-collection

    Item

    Approved licence issuance / collection

    Currency

    ZAR

    Amount Local

    3500

    Amount Local Formatted

    ZAR 3,500

    Frequency

    Per licence

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    certificate-of-free-sale

    Item

    Certificate of Free Sale

    Currency

    ZAR

    Amount Local

    1460

    Amount Local Formatted

    ZAR 1,460

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    clinical-trial-application

    Item

    Clinical-trial application - safety and efficacy, including devices/IVDs

    Currency

    ZAR

    Amount Local

    33700

    Amount Local Formatted

    ZAR 33,700

    Frequency

    Per application

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

  • Id

    inspection-charge-out

    Item

    Inspection charge-out rate

    Currency

    ZAR

    Amount Local

    1660

    Amount Local Formatted

    ZAR 1,660

    Frequency

    Per hour, per inspector

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Source Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Source Effective Date

    2025-02-12

    Verified On

    2026-08-25

Notes
  • These are establishment-licensing charges, not a universal per-product registration tariff.
  • South Africa’s device product-registration framework remains route-dependent.
  • Fees are set by GG 52106 GN 5856 of 12 February 2025: the new-licence row is R26,200 for a manufacturer licence and R15,600 for a distributor or wholesale licence.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    South Africa Government Gazette 52106: SAHPRA fees payable

    Url

    https://www.sahpra.org.za/wp-content/uploads/2025/02/Regulations-Regarding-Fees-Payable-In-Terms-Of-The-Provisions-Of-The-Medicines-And-Related-Substances-Act-1965-Act-No.-101-Of-1965.pdf

    Effective Date

    2025-02-12

    Accessed Date

    2026-08-25

  • Title

    SAHPRA current medical-device establishment-licensing fee guide

    Url

    https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v4-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments.pdf

    Effective Date

    2025-05-21

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open South Africa certifications →
Slug

south-africa

Market

South Africa

Confidence

low

Schemes
  • Id

    sahpra-electrical-emc-evidence

    Name

    SAHPRA electrical/EMC evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Source Urls
    • https://www.sahpra.org.za/radiation-control/
    • https://www.sahpra.org.za/wp-content/uploads/2025/03/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf
    Source Binding

    candidate

  • Id

    icasa-type-approval

    Name

    ICASA Type Approval

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Covered Radio Or Terminal Equipment

    Source Urls
    • https://www.icasa.org.za/pages/type-approval
    Source Binding

    candidate

  • Id

    nrcs-letter-of-authority

    Name

    NRCS Letter of Authority

    Category

    General Electrical Components

    Status

    Mandatory If Feature

    Object

    Product Under Compulsory Specification

    Source Urls
    • https://www.nrcs.org.za/business-units/electro-technical
    Source Binding

    candidate

  • Id

    sahpra-radiation-control

    Name

    SAHPRA Radiation Control

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Radiation Product Importer Or Use Site

    Note

    Hazardous Substances Act 15/1973 licences administered by SAHPRA Radiation Control: Group III electronic generators of ionising radiation (section 3; Regulation R1332 of 1973), Group IV radioactive sources (section 3A; Regulations R246 and R247 of 1993) and listed electronic products under the Schedule for Listed Electronic Products (Regulation R1302 of 1991), with licences for the import, manufacture, sale and use of listed products.

    Source Urls
    • https://www.sahpra.org.za/radiation-control/
    Source Binding

    reviewed

  • Id

    legal-metrology

    Name

    Legal Metrology

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Regulated Measuring Instrument

    Note

    Measuring devices must display South African legal units of measurement (or units acceptable to the Authority) per Essential Principle 10; class A devices with a measuring function require conformity-assessment evidence beyond the South African Declaration of Conformity (SAHPGL-MD-04 v5 §3.3).

    Source Binding

    unresolved

Official Sources
  • Authority

    ICASA

    Topic

    type approval

    Url

    https://www.icasa.org.za/pages/type-approval

  • Authority

    NRCS

    Topic

    electrotechnical compulsory specifications and Letter of Authority

    Url

    https://www.nrcs.org.za/business-units/electro-technical

  • Authority

    SAHPRA

    Topic

    radiation control licence categories hazardous substances act

    Url

    https://www.sahpra.org.za/radiation-control/

  • Authority

    SAHPRA

    Topic

    SAHPGL-MD-04 v5 measuring function classification requirements

    Url

    https://www.sahpra.org.za/wp-content/uploads/2025/03/SAHPGL-MD-04_v5-Guideline-for-Classification-of-MD-and-IVDs.pdf

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