South Africa: Regulating Everything Medical

Last Updated: 26 October 2011
Article by Neil Kirby

The draft regulations were published in the Government Gazette on 22 July 2011 (under notice 586 in Government Gazette No. 34463) for public comment. The three month period for public comment expired on or about 22 September 2011.

Regulations relating to medical devices

The proposed regulations consist of two sets of regulations. The first deals with regulations relating to medical devices. This set stands independently from regulations already in place under the Medicines and Related Substances Act No. 101 of 1965, as amended (the Medicines Act).

The scope and ambit of the regulations is dependant largely on whether or not a particular item falls within one of the eight categories of medical devices that are identified in proposed regulation 2. In so far as an item does fall within one of the categories, the item must be registered within that category as a medical device with the Medicines Control Council (the MCC).

The categories that have been published for comment are as follows:

" (a) Category C1: non-invasive medical devices which do not penetrate the body;

(b) Category C2: invasive medical devices that in whole or in part, penetrate the body, either through a body orifice or through the surface of the body;

(c) Category C3: active medical devices whose operation depend on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting energy;

(d) Category C4: combination medical devices that incorporate, as an integral part, a substance which, if used separately, can be considered to be a medicine, and which act son [sic] the human body with action ancillary to that of the medical device;

(e) Category C5: medical devices that are manufactured from or incorporating animal with human cell, tissue [sic] or derivative thereof;

(f) Category C6: medical devices used for sterilising or disinfecting other medical devices;

(g) Category C7: medical devices used for contraception or the prevention of the transmission of sexually transmitted diseases; and

(h) Category C8: in vitro diagnostic medical devices which, whether used alone or in combination, are 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".

The legal obligation to register a medical device will become operative once the final regulations are published. In terms of proposed regulation 4(1), the sale of an unregistered medical device will become prohibited.

The legal obligation to register a medical device will arise under proposed regulation 2. However, it is not clear whether or not the proposed regulations are to apply retrospectively to devices that are already in the marketplace and in use and where no sale occurs as contemplated in proposed regulation 4(1).

The proposed regulations endeavour to create a system of regulation in terms of which the MCC will determine which categories of medical devices are to be registered. Presumably, the MCC will issue a call-up notice, pursuant to proposed regulation 4(2), and require that category of medical devices to become registered.

In this regard, the resolution by the MCC will, in all likelihood, be published in the Government Gazette timeously under the direction of the Registrar of Medicines. Once such a publication occurs, an application for the registration of a medical device will have to be submitted to the MCC in accordance with the provisions and detailed contained in proposed regulation 5.

In terms of proposed regulation 6, manufacturers, importers or local representatives of such manufacturers of medical devices will have two years from the date that the regulations become effective to provide specified information to the Registrar of Medicines.

This information is set out in proposed regulations 6(1)(a) to (g) and includes the following:

" (a) name of the manufacturer or importer;

(b) address of [the] manufacturer or importer;

(c) name of [the] medical device;

(d) unique identification number, where practicable [of the medical device];

(e) [the] number [applied to medical device] according to an internationally recognised device nomenclature system as approved by the Council;

(f) category or class of medical device; and

(g) brief description of the medical device and its use".

Once the information is supplied to the Registrar, the Registrar will then allocate the medical device a number in accordance with proposed regulation 6(2). The number is not a registration, but rather recognition by the MCC of the existence of the device in the Republic.

Proposed regulation 6(4) allows the MCC to impose particular requirements on that medical device, which are currently unknown, "in order to ensure that the medical device is safe and of good quality".

The balance of the proposed regulations endeavour to align the control of medical devices with the manner of regulatory control already imposed by the Medicines Act on medicines.

Therefore, further proposed regulations deal with:

  • amending and updating registration details;
  • transferring certificates of registration;
  • licensing manufacturers,
  • exporters and importers; the duties of licence holders; and
  • cancelling a registration or licence.

Particular provision is also made for combination devices in proposed regulation 7.

Advertisements and promotions will be particularly controlled in terms of proposed regulation 13. In terms of proposed regulation 13(2), the MCC may prohibit the promotion or restrict the advertisement of certain medical devices "to the general public".

Proposed regulations for labelling and instructions for use for medical devices are contained in proposed regulation 14.

The manner in which medical devices are to be disposed of is outlined in proposed regulation 18.

In terms of proposed regulation 17, the MCC is afforded power to recall medical devices and specific duties are imposed upon persons using medical devices in health establishments. In this regard, the head of any health establishment attracts certain duties to ensure that the use of medical devices complies with the regulations in terms of proposed regulations 19 and 20.

In terms of proposed regulation 22 any person who contravenes the provisions of the proposed regulations, once final, is guilty of an offence. He or she will be liable for a fine and imprisonment for a period not exceeding five years or to both the fine and imprisonment.

Regulations relating to complementary medicines

Regulations concerning the control of complementary medicines are also proposed. However, these regulations are amendments to the existing general regulations in terms of the Medicines Act.

The scope and ambit of the amendments turn directly on the definition of "complementary medicine". A complementary medicine will be defined as follows:

"a medicine that is used –

  1. or intended to be used for, or manufactured or sold for use in assisting innate healing power of a human being or animal; and
  2. in accordance with the practice of the professions regulated under the Allied Health Professions Act, 1982 (Act No. 63 of 1982)" (emphasis added).

Complementary medicines fall within a category of medicines described as category D. Category D medicines are those in addition to the medicines or substances that are classified currently in categories A to C in terms of the General Regulations to the Medicines Act.

The introduction of formal regulations for complementary medicines is a significant step in the control of an extensive complementary medicines market in the Republic. Should the regulations proceed in their current format, complementary medicines - or substances falling within the four corners of the definition contained in the proposed regulations - will be subjected to the same process for registration as substances that fall into the existing categories A to C of the Medicines Act.

Therefore, complementary medicines will be treated in almost the same manner, from a regulatory and registration point of view, as is currently applicable to branded or allopathic medicines. Such a system of registration presents unique challenges for the purposes of controlling complementary medicines bearing in mind the broad nature of the types and variations of substances that fall within this category.

The one failing that is immediately noticeable is the division of complementary medicines into two distinct markets:

  • the first is the market defined by the definition contained in the proposed regulations, being the market dealt with and governed by the professions regulated under the Allied Health Professions Act No. 63 of 1982, and
  • the second is the market consisting of those complementary medicines that are used by professions not governed by the aforementioned Act or the Health Professions Act No. 56 of 1974, as amended.

The legality of such a definition will have to be carefully examined in relation to the principles of administrative law and the Constitution of the Republic of South Africa, 1996. This may produce the result that the definition of "complementary medicine", upon which legality of the balance of the regulations pertaining to complementary medicines rests, may be too vague for proper enforcement in terms of existing principles of South African law.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions