SAHPRA · structured requirements

🇿🇦 South Africa IVD regulatory data

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

14 facts8 dimensions13 official sourceslatest verification 2026-10-21

Changes after registration

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

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Change control

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

Compare countries

Successive amendments and renewal sequence

amendment.and.notification.sequence

Fact-level verified

All intended amendment changes must be stated in the cover letter and the updated full product listing includes approved products, with products intended for removal omitted as instructed. A further amendment may not be submitted while a prior amendment is pending. Product-list notifications may accompany renewal if the licence particulars and approved class do not change; amendments to company/entity/address/AR/holder/activities/personnel or new class must be filed after renewal is complete and the latest licence is issued.

Conditions

The cover-letter rule does not authorize one cross-regime filing/fee/clock for a new legal entity plus NIRMED or CFS changes.

Establishment amendment trigger and materials

establishment.amendment.trigger.and.documents

Fact-level verified

An establishment-licence amendment is required for changes to licence-holder particulars, an unapproved device class/category, responsible personnel/authorised representative, activities or special storage conditions reflected on the approved licence. MD10 requires a cover letter detailing the amendment, the latest complete application in Excel and signed/initialled PDF, proof of amendment payment, AR CV, updated quality manual or wholesaler site master file, current licence, and an ISO13485 certificate matching the licensed entity/address if available under the stated prerequisite. Submit by the designated medical-device administration email.

Conditions

This is establishment licensing, not a universal per-product marketing-authorization variation.
Apply the current Class A exemption before assuming an establishment licence is required.

GN 5855, GG 52105: Class A establishment-licence exemption, 12 February 2025

Class C/D originating-approval changes

foreign.approval.change.reporting

Fact-level verified

For a Class C or D device/IVD, the licence holder must submit full information within 30 days of a modification or a change in the status/certification of the originating approval supporting its licence application. Recall in that originating market requires immediate notification and recall action; withdrawal requires immediate notification and an agreed withdrawal plan. A corporate, brand or REF project must identify whether its supporting foreign approval actually changes.

Conditions

This is an applicant reporting duty, not an SAHPRA review time or an automatic sell-through allowance.

Additional listed-electronic-product licence gate

listed.electronic.product.change.route

Fact-level verified

If the product is a listed Group III electronic product, the NIRMED guidance requires a new licence application with compliance evidence for a manufacturer/brand change, a new brand/model name, or a different model. Administrative address/contact updates can be sent under the stated existing-licence detail-update route. Assess the actual R1302 listed category: the schedule includes blood-gas analysers, so the gate cannot be excluded solely because a product is an IVD. Local manufacture also includes assembly, preparation, processing, repair or maintenance under the Hazardous Substances Act.

Conditions

This is an additional conditional regime, separate from an establishment licence.
A pure orderable REF change is not automatically a licensed-model name change.
The current medical-manufacture application acceptance/form remains an authority interpretation issue; non-medical 01C, legacy MAN or X-ray-only XR24D must not be substituted as a confirmed current medical form.

R1302: Schedule of listed electronic products, 14 June 1991 Hazardous Substances Act 15 of 1973, consolidated

Product-list-only notification route and materials

product.list.notification.gate

Fact-level verified

A product-list update may use notification only where no other particulars of the issued establishment licence change and the approved classes remain unaffected. Original-manufacturer/supplier details and same-class product additions may fall within that gate. Submit the signed cover letter, AR declaration that licence/class details are unaffected, latest full application in Excel and PDF, current licence, retention-payment proof, supporting product documents and matching ISO13485 certificate if available. If licence particulars are affected, apply for amendment instead.

Conditions

The notification cannot absorb a change of local legal entity/address, AR, activity, personnel or approved class.
COVID-related updates have a separate Q&A amendment qualification.

SAHPGL-MD-07 v4: Guideline on Questions and Answers: Licensing of Medical Device Establishments (21 May 2025)

Notification implementation window and no application fee

product.list.notification.ten.day.condition

Fact-level verified

For a product-list-only notification within MD09’s conditions, no application fee is applicable. If SAHPRA has not responded or communicated an outcome within 10 working days after submission, the organisation may implement the change only if it does not constitute an amendment or otherwise affect particulars reflected on the licence. SAHPRA may require reclassification as an amendment; ten working days is not deemed approval for a change outside the notification gate.

Conditions

Do not apply this window to an establishment amendment, true successor licence or NIRMED application.

Dossier requirements

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

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CFS after identity/product changes

cfs.local.manufacturer.and.exempt.route

Fact-level verified

The 2026 CFS guideline applies to South African manufactured medical devices including IVDs for export, with a licensed-manufacturer route and a specific exempt Class A route. Submit GLF-MD-21A, destination/purpose cover letter, current manufacturer/product/GMDN/class particulars, licence and product listing where applicable, supporting conformity/ISO/essential-principles evidence as required and payment proof. Exempt Class A applicants instead supply the exemption declaration, classification rationale and labels/IFU/marketing evidence. Current manufacturer and product identities must match the requested certificate; a foreign product import change alone does not establish eligibility for a South African CFS.

Conditions

Confirm the manufacturer’s actual South African activity, Class A exemption details and destination needs.
The guideline’s Class A wording uses and/or in places; do not silently broaden eligibility for a borderline sterile/measuring portfolio.

GN 5855, GG 52105: Class A establishment-licence exemption, 12 February 2025

Economic-operator roles

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

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Same company amendment versus a new legal licensee

same.entity.versus.new.company

Fact-level verified

A company/establishment/entity-name change where the company registration remains the same is an establishment amendment. A South African establishment licence is not transferable to another company: each new applicant must obtain its own licence. An overseas original-manufacturer change that leaves all local licence particulars unchanged must instead be assessed under the product-list gate, with its updated supporting evidence; these are distinct roles.

Conditions

A change of contact or authorised representative is not proof of a change of legal entity.
If an actual product registration certificate exists, assess its separate statutory transfer route; an establishment amendment fee is not a product-certificate transfer fee.

SAHPGL-MD-07 v4: Guideline on Questions and Answers: Licensing of Medical Device Establishments (21 May 2025)Notification of an Update to the Product List(s) of a Medical Device Establishment Licence (MD09-2025/26, 27 January 2026) — SAHPRA document page

Establishment, import & distribution

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

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Class A establishment-licence exemption

class.a.establishment.exemption.condition

Fact-level verified

GN5855 of 12 February 2025 exempts the specified establishments dealing only in the described Class A medical devices/IVDs from section22C(1) establishment licensing for three years and repeals the 2024 exemption. Its operative text uses the wording “do not have measuring properties/characteristics and /or are non-sterile”; the 2026 CFS guide gives a separate exempt-applicant evidence route. Check the actual sterile/measuring characteristics and authority treatment rather than treating all Class A products or all IVDs as exempt.

Conditions

Conservative clear case: only non-measuring, non-sterile Class A portfolio. Borderline and/or cases need specific interpretation.
The exemption is not an exemption from label, vigilance or a triggered listed-electronic-product licence.

SAHPGL-MD-21 v1: Certificate of Free Sale guideline, 23 April 2026

Fees

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

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Establishment amendment fee gate

amendment.fee.versus.notification

Fact-level verified

A change that affects the approved establishment licence is a fee-bearing amendment under MD10 and the current gazetted establishment-licence amendment tariff. MD09’s qualified product-list-only notification carries no application fee. New-company establishment licensing, approved-licence issuance/collection, retention and CFS are distinct chargeable events; none is a universal product-registration transfer tariff.

Conditions

Use the separately referenced exact fee records for amounts; do not sum them into an automatic combined-case fee.

Medicines and Related Substances Act (101/1965): Regulations regarding fees payable in terms of the provisions of the Act, GN 5856, GG 52106, 12 February 2025 Notification of an Update to the Product List(s) of a Medical Device Establishment Licence (MD09-2025/26, 27 January 2026) — SAHPRA document page

Label, IFU & language

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

Compare countries

IVD label identity and separate catalogue field

ivd.label.change.identities

Fact-level verified

An IVD label must carry the name/trade name, product description/intended use, catalogue code where applicable, manufacturer name/business address, holder-of-registration name/business address and the other prescribed traceability/safety particulars. It must be in at least English. Catalogue code is an expressly distinct label field; an orderable REF does not by itself establish a new model or UDI. Reagents separately supplied from a kit must individually comply.

Conditions

Check product-specific UDI/GS1 requirements separately rather than treating REF and UDI as synonyms.

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 (5 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 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 cycles 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 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 SAHPRA 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

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

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

Review clocks

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

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CFS clock and validity

cfs.issue.time.and.validity

Fact-level verified

Where all CFS requirements are met, SAHPRA’s 2026 guideline states issue within 15 working days. Incomplete applications are not finalised until deficiencies are addressed; the applicant must respond within two working days and only two review opportunities are allowed. The certificate is valid for 12 months from issue. This CFS clock does not govern amendment, product registration, NIRMED or corporate-succession decisions.

Conditions

Use the current CFS tariff separately; a changed CFS is not automatic approval of the underlying establishment/product change.

Related structured datasets

Classification systems · 1 record

Open Risk classes A through D. →

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

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 South Africa registration →

Country

South Africa

Jurisdiction Id

south-africa

Country Code

Flag

🇿🇦

Regulator

South African Health Products Regulatory Authority

Regulator Abbrev

SAHPRA

Region

africa

Tier

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

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 South Africa fees →

Jurisdiction Id

south-africa

Country

South Africa

Country Code

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
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
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

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 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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Pricing

Changes after registration

Change control

Successive amendments and renewal sequence

Establishment amendment trigger and materials

Class C/D originating-approval changes

Additional listed-electronic-product licence gate

Product-list-only notification route and materials

Notification implementation window and no application fee

Dossier requirements

CFS after identity/product changes

Economic-operator roles

Same company amendment versus a new legal licensee

Establishment, import & distribution

Class A establishment-licence exemption

Fees

Establishment amendment fee gate

Label, IFU & language

IVD label identity and separate catalogue field

Reliance & recognition

South Africa approvals and evidence in other markets (0 records)

Prior approvals and evidence for South Africa (5 records)

China NMPA approval: not reference

China NMPA approval: outside SAHPRA reliance-guideline recognised authorities

CE Mark (EU MDR)

Recognised regulatory authority (reliance guideline)

FDA 510(k)/PMA

Review clocks

CFS clock and validity

Related structured datasets

More South Africa medical device resources