Introduction

In this article, we provide a brief overview of the requirements for the advertisement of medical devices in South Africa.

Requirements relating to advertisements

In terms of the Medicines and Related Substances Act 101 of 1965 (Act), the following requirements are applicable to the advertisement of medical devices:

  1. only low and moderate risk medical devices may be advertised to the public with the exception of male and female condoms;
  2. the advertisement of a medical device may not contain a statement which deviates from the evidence which was submitted and accepted for the purposes of applying for registration;
  3. a written advertisement of a medical device must contain its name as well as the registration number of the device if it has been registered; and
  4. an advertisement of a moderate high risk or high risk medical device must if the medical device is advertised to the prospective user for the first time be accompanied by information pertaining to how the medical device is to be used.

For the purposes of the Act, advertisements are defined as any written, pictorial, visual or other descriptive matter or other verbal statement (i) appearing in any newspaper, magazine, pamphlet, electronic media including radio and television or other publication, (ii) distributed to members of the public or (ii) brought to the notice of the public in any manner whatsoever.

Responsible persons

In addition to the persons selling medical devices being bound by the above-mentioned advertisement requirements, the Act also prohibits persons from publishing or distributing false advertisements. However, the Act provides that if the publisher or distributer of such advertisements can show that it did not know or could not reasonably have known that the advertisement was false, the distributer or publisher will not be prosecuted.

What are medical devices?

A medical device is defined as 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 contemplated in the Hazardous Substances Act, 1973, which:

  1. is intended by the manufacturer to be used, alone or in combination, for humans or animals, for one or more of the following:
    • diagnosis, prevention, monitoring, treatment or alleviation of disease;
    • diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
    • investigation, replacement, modification or support of the anatomy or of a physiological process;
    • supporting or sustaining life;
    • control of conception;
    • disinfection of medical devices; or
    • providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and
  2. does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means.

What is apparent is that the definition of a medical device is very wide. This means that it is likely that a number of medical instruments fall into this definition and the advertising of these devices will have to comply with the requirements as set out in the regulations.

Consequences of non-compliance

Non-compliance with the applicable advertisement requirements is an offence, the penalty for which is a fine and/or imprisonment for a period not exceeding 10 years.