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South Africa medical device registration resources

Research SAHPRA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every South Africa medical device resource.

8 free resources23/25 requirements covered3 regulations trackedAug 2026 fees reviewed
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Medical device registration database

Search official SAHPRA device registration records.

Medical device regulations

Browse official SAHPRA regulations and guidance documents.

AI medical device classifier

Describe your device and get a preliminary SAHPRA risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other South Africa requirements.

Medical device regulation news

Follow recent SAHPRA policy, guidance, safety, and compliance updates.

Government registration fees

Review current SAHPRA medical-device establishment and retention fee evidence.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare official and realistic SAHPRA approval times by device class and pathway.

Structured regulatory requirements

Explore all 49 source-linked facts →

23 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified
Competent authority
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 re…
Radiation-emitting device authority overlay
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)…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Primary statute
Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended by Act 72 of 2008 and Act 14 of 2015, is the primary statute; it broadened regulatory scope to medical devices a…
Medical device regulations
Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs), Regulation No. 1515 published in Government Gazette No. 40480 on 9 December 2016, made by the Ministe…
2 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
Medical device definition
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 re…
IVD definition
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 o…
3 source-linked facts
Checked 2026-08-25
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D04

Classification rules

Verified
Risk classes A through D.
Class A, Class B, Class C, Class D
1 maintained scheme
Checked 2026-08-25
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D05

Registration pathways

Verified
Establishment licence types
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 distributo…
Product registration status
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 typ…
4 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
Recognised reference jurisdictions
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…
WHO Collaborative Registration Procedure for IVDs
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.
2 source-linked facts
Checked 2026-08-25
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D07

Economic-operator roles

Verified
Authorised representative role
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 p…
Representative or holder change
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…
3 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Licence required to trade
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 20…
Designated ports of entry
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, Ki…
4 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Licence application content
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 aut…
Registration application content
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 o…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Current application forms
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 Applic…
Submission channel
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…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Label particulars and language
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…
Instructions for use language
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 incl…
2 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
ISO 13485 requirement
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 an…
1 source-linked fact
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
SAHPRA electrical/EMC evidence
Electrical safety
ICASA Type Approval
Wireless / radio
NRCS Letter of Authority
Adapters / components
5 maintained overlays
Checked 2026-09-07
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D14

Fees

Verified
New medical-device/IVD establishment licence - manufacturer
ZAR 26,200
New medical-device/IVD establishment licence - distributor or wholesaler
ZAR 15,600
11 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Unresolved
Medical device establishment licence · SAHPRA establishment licensing
6-8 weeks
Medical device establishment licence renewal
4-8 weeks
2 maintained pathways · 1 related fact
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Establishment licence validity
A licence issued under regulation 5 (medical device establishment licence) is valid for a period of five (5) years from the date of issue.
Expiry or lapse consequence
If the licence expires, the applicant is prohibited from trading; late renewal submissions are refused and a new application is required.
3 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Change notification and amendment
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…
Product list update
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 devic…
2 source-linked facts
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Device listing on licence
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 licens…
Implantable and custom-made record retention
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, devic…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical investigation authorisation
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 qualifi…
1 source-linked fact
Checked 2026-08-25
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D20

Special access & derogation

Verified
Section 21 unregistered product authorisation
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 part…
Custom made device regime
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)) b…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market safety duties
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…
1 source-linked fact
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Serious public health threat deadline
48
Death or serious deterioration deadline
10
4 source-linked facts
Checked 2026-08-25
Open details →
D23

Recall, FSCA & market surveillance

Verified
Field Safety Corrective Action reporting
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,…
Recall notification channel
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 devic…
2 source-linked facts
Checked 2026-08-25
Open details →
D24

Advertising, claims & promotion

Verified
Public advertising class restriction
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.
Advertisement content rules
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…
2 source-linked facts
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Appeal process
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; t…
1 source-linked fact
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (11 lines) →

SAHPRA registration fees in ZAR · reviewed 2026-08-25

Fee lineAmountProvenance
New medical-device/IVD establishment licence - manufacturerZAR 26,200Verified
New medical-device/IVD establishment licence - distributor or wholesalerZAR 15,600Verified
Establishment-licence renewal - manufacturerZAR 22,900Verified
Establishment-licence renewal - distributorZAR 13,160Verified
7 more fee lines on the full schedule · 11 of 11 rows source-verified

Registration timeline

Full registration timeline →

South African Health Products Regulatory Authority (SAHPRA) review clocks and planning ranges · 4-class (A, B, C, D) — EU-aligned (licence-based system) classification

Class / pathwayReview clockPlanning totalProvenance
Medical device establishment licence(SAHPRA establishment licensing)6-8 weeks2-4 monthsVerified
Medical device establishment licence renewal4-8 weeks2-4 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(6-8 weeks)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 3 South Africa regulations →

Official SAHPRA rules and guidance · 3 of 3 documents linked to official sources

Government Gazette No. 40480 / Regulation 1515Regulations Relating to Medical Devices and IVDs
GeneralVerified
SAHPGL-MD-04 Version 5Classification of Medical Devices and IVDs
ClassificationVerified
SAHPGL-MD-22 Version 1Medical Device Regulatory Reliance Guideline
RegistrationVerified
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South Africa market-launch workpaper

Connect the SAHPRA route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

South Africa dossier reuse and delta

Compare an existing authorization and evidence set against SAHPRA administrative, testing, labeling, and dossier needs.

South Africa change notification workpaper

Map a product or manufacturing change to SAHPRA evidence, notification, timing, and implementation questions.

South Africa regulatory change impact

Assess a current SAHPRA update against one product and turn it into an owner-ready action workpaper.

South Africa cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for South Africa (SAHPRA).

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