Explore the medical device requirements currently available for South Africa, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
A licence issued under regulation 5 (medical device establishment licence) is valid for a period of five (5) years from the date of issue.
If the licence expires, the applicant is prohibited from trading; late renewal submissions are refused and a new application is required.
Confirms baseline lapse fact on an official SAHPRA page.
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.
FAQ: 'The license renewal application must be submitted at least 90 days prior to the license expiry date.'
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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).
Confirms baseline change-control fact; regulation text also verified directly in the gazette.
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.
Page quote: 'Regulation 5(7) ... makes provision for the amendment of a medical device establishment licence.'
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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.
Confirms the baseline archetype: a responsible natural person, not the EU AR legal-entity archetype.
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.
Confirms baseline representative-change fact; SAHPRA process document MD10-2025/26 (27 Jan 2026).
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.
Gazette OCR text.
Which current law, regulation, guidance, and transition provisions apply?
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 and IVDs and provides for establishment licensing (s22C(1)(b)), licence validity/renewal (s22D), s21 authorisation for unregistered products, and s36 exemptions.
Consolidated Act text as published in GG 40869.
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 Minister of Health in terms of section 35(1)(xxvii) of Act 101/1965, govern licensing (reg 5-6), registration (reg 8-12), clinical investigations (reg 16), vigilance (reg 17), advertising (reg 21), labelling/IFU (reg 22-24) and transitional call-up (reg 27-28).
Is the product a device, IVD, accessory, software, or borderline product locally?
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).
Definition substituted by s1(g) of Act 72/2008 and s1(h) of Act 14/2015.
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.
Gazette OCR text.
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.
Gazette OCR text.
Which registration, notification, listing, reliance, or conformity route applies?
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.
SAHPRA's unit page confirms the three licence types are currently the operative market-entry control.
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)).
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.'
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.
FAQ cross-reference: 'the requirement is applicable even in cases where the establishment is exempted from licensing'.
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.
The six recognised jurisdictions are listed in SAHPGL-MD-07 v4: Australia, Brazil, Health Canada, Europe, Japan, USFDA.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
The SAHPRA Medical Devices page confirms reliance pathways will use registrations in these recognised jurisdictions or WHO PQ.
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.
Confirms the existing WHO PQ-to-CRP reliance edge on an official SAHPRA page.
Which establishment licences, importer permissions, and distribution controls apply?
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.
A 2017 gazette notice requested manufacturers and distributors to apply within 6 months (wholesalers 12 months).
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.
Gazette OCR text.
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.
Gazette full text hosted on SharePoint; verified via SAHPRA's official notice page.
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.
Gazette OCR text.
Which evidence, local deltas, formats, and signatures are required?
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.
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.
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.
Gazette OCR text. Reg 8(4): 'The information referred to in sub-regulation (3) must, at least, be in English.'
Which current form, portal, account, and submission package must be used?
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'.
Licence application forms are completed in Microsoft Excel with formatting restricted; a signed/initialed PDF is also submitted.
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.
Enquiries to mdenquiries@sahpra.org.za; general enquiries enquiries@sahpra.org.za.
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
Gazette OCR text.
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).
Gazette OCR text.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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.
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.'
What regulator fee applies to this class, route, event, and date?
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.
Fee gazette scanned; text recovered by OCR.
What review, validation, and applicant stop-clock rules apply?
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.
Stop-clock style rule: the 6-8 week processing time depends on applicant response time.
Which UDI, device listing, database, and traceability duties apply?
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).
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.
Gazette OCR text.
Which clinical or IVD performance evidence or study is required and accepted?
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'.
Gazette OCR text; form and fee verified on SAHPRA forms page and fee gazette.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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.
Section 36 of the Act separately allows applications for exemption from any provision of the Act (SAHPGL-MD-07 s3.1.25).
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).
Gazette OCR text.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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.
SAHPGL-MD-03 s4.3: exempt events must still be documented with reasons for non-reporting retained on record.
What is reportable, by whom, where, in what format, and by what deadline?
48
Report on form GLF-MD-11A to mdvigilance@sahpra.org.za.
10
If uncertain whether an event is reportable, a report must be submitted within the timeframe for that event type.
30
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).
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.
Document dated 24 June 2026, signed by the SAHPRA CEO.
Which recall, FSCA, notice, and authority-coordination duties apply?
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.
Regulation 18 additionally allows Council investigation where a device is recalled in South Africa or any other country or an international alert exists.
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.
SAHPRA's document archive publishes classified recall notices (e.g. Class I Type B, August 2026).
Which claims, audiences, channels, approvals, and restrictions apply?
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.
Gazette OCR text ('Class 8' is an OCR artifact for Class B).
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.
Offences: contravening the advertising regulation is punishable by a fine or imprisonment up to 10 years (reg 19(1)(f)).
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
Appeals are contemplated in section 24 of the Act. Gazette OCR text.
