**Medical Device Regulatory\
Requirements for\
South Africa**

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| **Disclaimer:** The information contained on this website is derived  |
| from public sources and is current to the best of our knowledge. For  |
| detailed and definitive information about a country\'s laws and       |
| policies, the government of the country concerned should be           |
| consulted.                                                            |
|                                                                       |
| **Introduction to South Africa Regulatory System**                    |
|                                                                       |
| The medical device market is not very well regulated in South Africa. |
| South Africa does not have a comprehensive system of medical device   |
| regulation. However, the market is very sophisticated and it is       |
| strongly advisable that the product be FDA approved or even better,   |
| carry the EC mark. The exception is for electromagnetic medical       |
| devices (or radiation emitting devices), which must be registered     |
| with the Department of Health, and must have the CE mark. FDA         |
| approved electro-medical products without the CE mark will not be     |
| accepted. A license must be obtained from the Directorate: Radiation  |
| Control, by any dealer wishing to sell a listed electro-medical       |
| product in the South African market, and the relevant application     |
| form has to be completed and attached for that purpose.               |
|                                                                       |
| However, electro-medical devices are regulated. The Directorate:      |
| Radiation Control of the South African Department of Health is        |
| responsible for regulatory control over the sale and use of the       |
| attached schedule of listed electronic products (below).              |
|                                                                       |
| **Regulatory System**                                                 |
|                                                                       |
| According to the Department of Health, South Africa does not make a   |
| distinction between refurbished/used and new medical equipment.       |
| Medical equipment -- other than electro medical devices -- including  |
| disposable or single use devices, is not regulated. The South African |
| Department of Health is currently in the process of drafting the      |
| necessary policy documents and has indicated that these may become    |
| available some time in the future.                                    |
|                                                                       |
| There are no special tariffs or restrictions reserved for             |
| used/refurbished equipment, as there is no distinction made between   |
| new and refurbished/used medical devices. No third party may legally  |
| import the same device in used/refurbished condition without the used |
| device being subjected to new safety inspections, since each importer |
| must obtain a license for each model that he/she imports. There are   |
| no restrictions on the number of licensed importers allowed per model |
| currently.                                                            |
|                                                                       |
| The sale of used equipment locally is not regulated. Public health    |
| institutions generally do not purchase refurbished/used medical       |
| equipment due to tendering conditions and/or internal hospital        |
| policy. However, there is no law prohibiting them from doing so.      |
|                                                                       |
| Single use or disposable devices are being reprocessed and reused by  |
| health practitioners, and is frequently done so in both private and   |
| public hospitals. Although not regulated yet, this practice is of     |
| considerable concern.                                                 |
|                                                                       |
| As mentioned, there are, however, exceptions with regard to specific  |
| electro medical products. Although there is no distinction between    |
| new and refurbished/used equipment, all importers -- whether the      |
| product is destined for commercial or personal use -- must apply for  |
| a license in terms of Section 4 (1)(b) of the Hazardous Substances    |
| Act, 1973 (Act 15 of 1973) from the Department of Health,             |
| Directorate: Radiation Control. Potential importers must apply for a  |
| license [for each model]{.underline} and must supply the following    |
| documentation:                                                        |
|                                                                       |
| 1.  Completed application form 41BM-1, obtainable from the Radiation  |
|     Directorate                                                       |
|                                                                       |
| 2.  A color brochure (including technical specifications) from the    |
|     manufacturer                                                      |
|                                                                       |
| 3.  A letter of appointment as authorized representative of the       |
|     original manufacturer                                             |
|                                                                       |
| 4.  EC Certificate(s) issued by a Notified Body in terms of EC        |
|     Directive 93/42/EEC, or 90/385/EEC (whichever one is applicable)  |
|                                                                       |
| 5.  EC Declaration of Conformity by the manufacturer in terms of EC   |
|     Directive 93/42/EEC or 90/385/EEC (whichever one is applicable).  |
|                                                                       |
| **Please note that FDA-approved only electro medical products are no  |
| longer accepted for import in South Africa. The Directorate will      |
| recognize EC certification only.**                                    |
|                                                                       |
| If the intention is to conduct clinical trials with a listed electro  |
| medical product, before it has been licensed to be imported or        |
| manufactured in South Africa, the importer must supply the following  |
| documentation:                                                        |
|                                                                       |
| > 1\. Completed application form 41BM-1, obtainable from the          |
| > Radiation Directorate                                               |
| >                                                                     |
| > 2\. Color brochure (including technical specifications) from the    |
| > manufacturer                                                        |
| >                                                                     |
| > 3\. A letter of appointment as authorized representative of the     |
| > original manufacturer                                               |
| >                                                                     |
| > 4\. List of medical institutions where the clinical trials will be  |
| > conducted                                                           |
| >                                                                     |
| > 5\. List of the medical practitioners who will supervise the        |
| > clinical trials                                                     |
|                                                                       |
| F. 6. Copy of the letter in which the Medical Ethics Committee of a   |
| medical institution gives approval for the clinical trials to be      |
| performed at that particular medical institution                      |
|                                                                       |
| > 7\. Copy of the approved Research Protocol for the clinical trials  |
| >                                                                     |
| > 8\. Copy of the "Informed Consent" form                             |
|                                                                       |
| This product must be re-exported to the original manufacturer after   |
| completion of the clinical trials and may not be re-sold in South     |
| Africa. However, if the model is to be offered for local sale then EC |
| documentation (as outlined in Points 3 and 4) must be submitted.      |
| Further, the date of importation or manufacture of units of that      |
| model may not precede the dates of the documentation required under   |
| Points 3 and 4.                                                       |
|                                                                       |
| Electro- medical devices are regulated. The Directorate: Radiation    |
| Control of the South African department of Health is responsible for  |
| regulatory control over the sale and use of the attached schedule of  |
| listed electronic products.                                           |
|                                                                       |
| ### T                                                                 |
| he Schedule of Listed Electronic Products Hazardous Substances Act, N |
| o. 15 of 1973 Regulation No. R. 1302, 14 June 1991 are the following: |
|                                                                       |
| **A Any electronic product generating X-rays or other ionizing beams, |
| electrons, neutrons or other particle radiation, namely-**            |
|                                                                       |
| 1\. any diagnostic X-ray unit, including medical, dental and          |
| veterinary units;                                                     |
|                                                                       |
| 2\. any therapeutic X-ray unit;                                       |
|                                                                       |
| 3\. any X-ray unit used for industrial, research, educational,        |
| security or any other purposes;                                       |
|                                                                       |
| 4\. any electron accelerator;                                         |
|                                                                       |
| 5\. any heavy particle accelerator;                                   |
|                                                                       |
| 6\. any neutron generator;                                            |
|                                                                       |
| 7\. any electron microscope;                                          |
|                                                                       |
| 8\. any visual display unit, including any television receiving       |
| apparatus and video display monitoring system, that employs a cathode |
| ray tube with an accelerating voltage exceeding 15kV; and             |
|                                                                       |
| 9\. any cold cathode gas discharge tube producing X-rays, including   |
| those for teaching of X-ray principles and high voltage switchgear.   |
|                                                                       |
| **B Any electronic product generating electromagnetic radiation in    |
| the ultraviolet region, namely**                                      |
|                                                                       |
| 1\. any sunlamp designed for the tanning of the skin of a human       |
| being;                                                                |
|                                                                       |
| 2\. any therapeutic lamp;                                             |
|                                                                       |
| 3\. any high-intensity mercury-vapor discharge lamp;                  |
|                                                                       |
| 4\. any intra-oral curing device; and                                 |
|                                                                       |
| 5\. any ultraviolet A lamp, including 'black lights'.                 |
|                                                                       |
| **C Any electronic product emitting coherent electromagnetic          |
| radiation produced by stimulated emission, namely all laser products  |
| that emit radiation in excess of 0,8 x 10-9 watt in the wavelength    |
| region up to and including 400 nm or that emit radiation in excess of |
| 0,39 x 10-6 watt in the wavelength region greater than 400 nm.**      |
|                                                                       |
| **D Any electronic product emitting electromagnetic radiation in the  |
| infrared region, namely -**                                           |
|                                                                       |
| 1\. any industrial heating and drying lamp installation exceeding 200 |
| watt; and                                                             |
|                                                                       |
| 2\. any medical heating lamp exceeding 200 watt.                      |
|                                                                       |
| **E Any electronic product emitting microwaves, radio or low          |
| frequency electro­magnetic radiation, namely-**                        |
|                                                                       |
| 1\. any microwave oven;                                               |
|                                                                       |
| 2\. any microwave diathermy unit;                                     |
|                                                                       |
| 3\. any short-wave diathermy unit;                                    |
|                                                                       |
| 4\. any electro surgical unit;                                        |
|                                                                       |
| 5\. any neuro-muscular stimulator;                                    |
|                                                                       |
| 6\. any medical magnetic stimulator;                                  |
|                                                                       |
| 7\. any radio-frequency generating device, system or installation,    |
| including radars, generating a radio-frequency output exceeding 200   |
| watt RMS;                                                             |
|                                                                       |
| 8\. any low power radio-frequency generating device, system or        |
| installation, including citizen band radios, land mobile              |
| transmitters, marine transmitters and two-way (walkie talkie) radios, |
| where normal operation entails close proximity to the operator or     |
| third parties and generating a radio-frequency output exceeding 25    |
| watt RMS;                                                             |
|                                                                       |
| 9\. any microwave generating device, system or installation,          |
| including radars, generating a microwave output exceeding 400 watt    |
| RMS ;                                                                 |
|                                                                       |
| 10\. any radio-frequency sealer;                                      |
|                                                                       |
| 11\. any magnetic resonance imaging device; and                       |
|                                                                       |
| 12\. any blood warmer.                                                |
|                                                                       |
| **F Any electronic product emitting ultrasonic vibrations, namely-**  |
|                                                                       |
| 1\. any diagnostic ultrasound appliance;                              |
|                                                                       |
| 2\. any therapeutic ultrasound appliance;                             |
|                                                                       |
| 3\. any surgical ultrasound appliance;                                |
|                                                                       |
| 4\. any lithotripsy appliance; and                                    |
|                                                                       |
| 5\. any pest and rodent control appliance.                            |
|                                                                       |
| **G Any electronic product used for medical, dental or veterinary     |
| applications em­ploying radio-active nuclides, namely -**              |
|                                                                       |
| 1\. any gamma camera;                                                 |
|                                                                       |
| 2\. any whole body counter;                                           |
|                                                                       |
| 3\. any positron emission tomography scanner;                         |
|                                                                       |
| 4\. any linear scanner; and                                           |
|                                                                       |
| 5\. any single photon emission computed tomograph (SPECT).            |
|                                                                       |
| **H Any high-risk electronic product used for medical or dental       |
| applications, namely -**                                              |
|                                                                       |
| 1\. any intra-aortic balloon pump;                                    |
|                                                                       |
| 2\. any electronically controlled ventilator;                         |
|                                                                       |
| 3\. any electronically controlled anesthetic machine;                 |
|                                                                       |
| 4\. any cardiac pacemaker;                                            |
|                                                                       |
| 5\. any intra-cardiac electro- and phono-cardiographic monitor;       |
|                                                                       |
| 6\. any electro convulsive therapy unit;                              |
|                                                                       |
| 7\. any photo coagulator;                                             |
|                                                                       |
| 8\. any infusion pump;                                                |
|                                                                       |
| 9\. any syringe pump;                                                 |
|                                                                       |
| 10\. any infant incubator;                                            |
|                                                                       |
| 11\. any infant transport incubator;                                  |
|                                                                       |
| 12\. any hyper baric therapy chamber;                                 |
|                                                                       |
| 13\. any hem dialysis device;                                         |
|                                                                       |
| 14\. any peritoneal dialysis machine;                                 |
|                                                                       |
| 15\. any heart-lung bypass (perfusion) device;                        |
|                                                                       |
| 16\. any shockwave lithotripsy device;                                |
|                                                                       |
| 17\. any auto transfusion device;                                     |
|                                                                       |
| 18\. any high pressure injection device;                              |
|                                                                       |
| 19\. any cryosurgical device; and                                     |
|                                                                       |
| 20\. any transcutaneous O2/CO2 monitor.                               |
|                                                                       |
| **I Any medium risk electronic product used for medical or dental     |
| applications, namely -**                                              |
|                                                                       |
| 1\. any audiometer;                                                   |
|                                                                       |
| 2\. any ambulatory electrocardiographic recorder;                     |
|                                                                       |
| 3\. any electrocardiograph;                                           |
|                                                                       |
| 4\. any electroencephalograph;                                        |
|                                                                       |
| 5\. any electromyograph;                                              |
|                                                                       |
| 6\. any cardiac catheterization laboratory system;                    |
|                                                                       |
| 7\. any physiological monitor (ECG, pressure, respiration,            |
| temperature);                                                         |
|                                                                       |
| 8\. any phonocardiograph;                                             |
|                                                                       |
| 9\. any non-invasive blood pressure monitor;                          |
|                                                                       |
| 10\. any cardiac output computer;                                     |
|                                                                       |
| 11\. any plethysmograph;                                              |
|                                                                       |
| 12\. any evoked response device;                                      |
|                                                                       |
| 13\. any pulmonary function analyzer;                                 |
|                                                                       |
| 14\. any blood gas analyzer;                                          |
|                                                                       |
| 15\. any infusion controller;                                         |
|                                                                       |
| 16\. any interferential device;                                       |
|                                                                       |
| 17\. any capnograph; and                                              |
|                                                                       |
| 18. any diagnostic exercise device, including treadmill               |
|                                                                       |
| Duties                                                                |
|                                                                       |
| Duties are not payable on most medical and laboratory equipment.      |
| Some, such as blood sample collection tubes may carry a Most Favored  |
| Nation (MFN) or Standard duty calculated at 10% of the value, and     |
| duties may be payable on certain plastics and disposables. An extra   |
| copy of customs paperwork will be needed for other products.          |
|                                                                       |
| Value added tax (VAT) is payable on all items imported into South     |
| Africa. The VAT is refundable to all local VAT registered importers.  |
|                                                                       |
| There are no special tariffs or restrictions reserved for             |
| used/refurbished equipment, as there is no distinction made between   |
| new and refurbished/used medical devices.                             |
|                                                                       |
| **Procurement Practices**                                             |
|                                                                       |
| Generally, it is the reagents that are purchased, and the analyzers   |
| are placed with the reagents. In other words, high volume analyzers   |
| are normally rented for a minimum fee that is added to the price of   |
| the reagents. Mid-range analyzers will normally carry a small rental  |
| fee, while low-range analyzers will be purchased outright, since the  |
| small amount of reagents needed will not cover the cost of the        |
| analyzer.                                                             |
|                                                                       |
| In the private sector, some laboratory groups will follow a more      |
| informal tender process and procurement may also be done directly via |
| the manufacturer if it is unavailable in the country. However, the    |
| public sector (such as the NHLS or universities and hospitals, who    |
| process their own equipment) will adopt a formal procedure and will   |
| source from local representatives only, unless the product is not     |
| available in South Africa. It is also likely that they will need to   |
| be on the institution's preferred supplier list.                      |
|                                                                       |
| All public procurements are subject to the Public Procurement Law No: |
| 4734-4735 and the related directives, which establish the principles  |
| and procedures to be applied in procurements held by all public       |
| entities and institutions governed by public law or under public      |
| control or using public funds. For detailed information please visit  |
| <http://www.kik.gov.tr/index2.htm>                                    |
|                                                                       |
| **Distribution Systems**                                              |
|                                                                       |
| Typically, distribution is done through local agents and              |
| distributors. In South Africa, there is a distinction between an      |
| agent and a distributor. The agent orders the product on ad-hoc basis |
| and generally works on a commission basis. The distributor will       |
| usually have a larger stocking capacity and enters into a formal      |
| agreement with the manufacturer. Some will only carry a specific      |
| brand name and become a subsidiary, e.g. Bayer (Pty) Ltd South        |
| Africa. Others may carry a string of non-competing products from      |
| different manufacturers. Most potential distributors with a national  |
| sales territory will prefer to have exclusive arrangements with the   |
| original manufacturer. It is important to ensure that local           |
| distributors have maintenance and after-sales repair capabilities,    |
| and train staff regularly.                                            |
|                                                                       |
| Please note that the South African standard for electrical voltage is |
| 220 volts, as opposed to the US standard of 110.                      |
|                                                                       |
| **Contact Lists:**                                                    |
|                                                                       |
| Felicity Nagel                                                        |
|                                                                       |
| Commercial Specialist                                                 |
|                                                                       |
| U.S. Commercial Service                                               |
|                                                                       |
| Cape Town, South Africa                                               |
|                                                                       |
| Tel: +27-21-702-7300 Ext. 7345                                        |
|                                                                       |
| Fax: +27-21-702-7402                                                  |
|                                                                       |
| E-mail: <Felicity.Nagel@mail.doc.gov>                                 |
|                                                                       |
| Mr. Leon du Toit, Deputy Director (NIRMED)                            |
|                                                                       |
| Directorate: Radiation Control                                        |
|                                                                       |
| Department of Health                                                  |
|                                                                       |
| Private Bag X62                                                       |
|                                                                       |
| Bellville 7535                                                        |
|                                                                       |
| South Africa                                                          |
|                                                                       |
| Tel: +27-21-957-7483 (direct line)                                    |
|                                                                       |
| Fax: +27-21-946 1589                                                  |
|                                                                       |
| E-mail: <dutoil@health.gov.za>                                        |
|                                                                       |
| South African Medical Device Industry Association (SAMED)             |
|                                                                       |
| Mr. Owen Hooker -- Executive Director                                 |
|                                                                       |
| email: owenh@medco.co.za                                              |
|                                                                       |
| P.O. Box 651761                                                       |
|                                                                       |
| Benmore                                                               |
|                                                                       |
| 2010 Johannesburg                                                     |
|                                                                       |
| South Africa                                                          |
|                                                                       |
| Tel: +27-11-777-7585                                                  |
|                                                                       |
| Fax: +27-11-777-7501                                                  |
|                                                                       |
| [www.samed.co.za](http://www.samed.co.za/)                            |
|                                                                       |
| South African Bureau of Standards is currently in the process of      |
| drafting standards regulation for medical devices.                    |
|                                                                       |
| South African Bureau of Standards (SABS) -- SA equivalent to the UL   |
|                                                                       |
| Ms. Cecilia Woker                                                     |
|                                                                       |
| Tel: +27 12 428 6718                                                  |
|                                                                       |
| Fax: (012) 344 1568                                                   |
|                                                                       |
| Email: <wokercf@sabs.co.za>.                                          |
|                                                                       |
| Private Bag X191\                                                     |
| Pretoria 0001                                                         |
|                                                                       |
| [www.sabs.co.za](http://www.sabs.co.za/)                              |
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