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Focus on Regulation

Medical devices – South Africa’s changing landscape

Subject to certain exceptions, medical devices have historically not been heavily regulated in South Africa.  Prescriptive requirements for medical devices were not in force and advertisers and marketers of medical devices had few legislative and regulatory formalities to comply with.

As of December 2016, the local regulatory framework governing medical devices underwent a substantial overhaul, as the regulations relating to medical devices and in vitro diagnostic medical devices (“IVD devices“) were published by the Minister of Health (“Device Regulations“).

The primary purpose of the Device Regulations is to provide for the registration of medical and IVD devices, including matters related thereto.  By means of a high-level summary, the Device Regulations provide for the following:

  1. Requirements regarding the importation of medical and IVD devices into South Africa.
  2. The process for the application by a manufacturer, wholesaler or distributor of medical and IVD devices for a manufacturer, distributor or wholesale licence. The Device Regulations go further to indicate the period of validity of a licence and the renewal thereof.
  3. Details regarding the application process for the registration of medical and IVD devices as well as the classification thereof.
  4. The introduction of various offences and penalties in relation to non-compliance with certain of the Device Regulations (i.e. a failure to comply, or a contravention or intentional submission of incorrect information, in respect of certain regulations, amounts to an offence that may result in a fine or imprisonment for a period not exceeding 10 years).
  5. Requirements relating to the advertising of medical and IVD devices, as well as the labelling thereof.

In addition, the Medicines and Related Substances Amendment Act 72 of 2008 (“Amendment Act”), which substantially amends the provisions contained in the Medicines and Related Substances Act 101 of 1965 (“Medicines Act“), commenced on 1 June 2017.

In terms of the Amendment Act, medical and IVD devices are now included in the general requirement that, unless exempted, no person may sell any  medical or IVD device, which is subject to registration, without it being registered.

It is important to note that the definition of “sell” in the Medicines Act includes to “advertise”.

Section 14 of the Amendment Act provides that no person shall advertise any medical or IVD device, unless such advertisement complies with the prescribed requirements, as detailed in the Device Regulations.

The existing restrictions in the Medicines Act regarding bonusing and sampling have been amended in order to include medical and IVD devices within the ambit thereof.

Importantly, section 19 of the Amendment Act is a particularly noteworthy section in that it now includes medical and IVD devices within the prohibition of publication or distribution of false advertising.

Section 24 of the Amendment Act stipulates that a manufacturer, wholesaler or distributer of medical or IVD devices, may not manufacture, act as a wholesaler of, or distribute, as the case may be, any medical or IVD device, unless it is a holder of a licence.  This aligns with the comparable provisions in the Device Regulations.

The above is intended to provide an overview of the noteworthy changes as regard medical and IVD devices, from what has been a relatively unregulated environment to one that is now more highly regulated, however this is not a detailed list of all of the amendments effected to the Medicines Act.

The South African regulatory authority’s deadline for submission of licensing applications, in respect of domestic manufacturers and distributors of medical and IVD devices, is August 2017.

Domestic medical and IVD device wholesalers have until February 2018 to submit their licensing applications to the regulator.