Medical Device Regulation in South Africa: What's Next?

By: Angela Gamalski

Medical devices play a crucial role in management of modern healthcare needs. The World Health Organization has defined a medical device to be “an article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or diseases, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose.”[1] Medical devices can range from the simplest tools, such as a tongue depressor or bandage, to highly complex machines, such as an implanted insulin pump.[2] The range of possible uses for these devices create significant risks if the device fails to work as intended. For the most complex of these devices, a product failure will likely result in a serious outcome for the patient and could result in the patient’s death.

Due to the potential for significant legal liabilities for such devices, modern legal systems have established a preemptory product liability system for medical devices.[3] Under such systems, existing product liability laws may have a carve-out for medical devices, or a national standard supersedes any local product liability case law. Additionally, devices are classified and scrutinized according to the risk posed by the device.

The World Health Organization has defined some standard uses and expectations for medical devices. However, while many countries can agree on a classification system for medical devices, there is less agreement on how to regulate and assign liability for defects. As a result, there is not one universal legal standard to control the usage of medical devices, which are increasingly able to move about the globe. There has been some attempt to harmonize legal standards for medical devices. [4]  In 2011, the International Medical Device Regulators Forum was established, with membership representing Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, and United States.[5]

The majority of medical device development and innovations currently happens in the United States and European Union countries. As a result, most countries outside these regions have derived medical device liability laws and regulations from either those established by the United States Food and Drug Administration or the previous European Union Medical Device Directive. The nation of South Africa is no exception.

South Africa, despite having a relatively minimal health infrastructure, is the wealthiest African nation and is also a leading supplier of medical devices to other African nations.[6] As imported medical devices become less affordable, the need for locally developed medical devices increases.[7] Local medical device demand is concentrated on relatively simple medical devices. Local medical device manufacturers need reasonable guidelines for development of products for this market. Under South Africa’s existing product liability laws, the manufacturer of a noncompliant product may be found criminally liable for any consumer harm which results as of the product’s deviation from proscribed safety standards.[8]

Traditionally, South African medical device regulation was traditionally limited to electronic medical devices which have E.U. market approval.[9] In December 2016, South Africa officially established its own medical device laws.[10] South Africa based its laws on the International Medical Device Regulators Forum and the then-European Union Medical Device Directive.[11] South Africa has established a national licensing system for medical devices, but this system is only applicable to those devices used in South Africa’s public health system.[12] By contrast, devices in the private health care system, which treats 70% of South Africans, are exempt from the licensing requirements.[13]

In 2017, the European Union finalized a new Medical Device Regulation.[14] This regulation replaces the previous Medical Device Directive and following a three-year transition period will become effective in 2020.[15] This nomenclature change, from a Regulation to a Directive, takes the EU’s standards from a recommendation that member states may adopt or adapt to a mandatory regulatory floor. Substantive changes include expansion of a medical device definition to include software intended for medical purposes;[16] establishment of a pan-European medical device database known as EUDAMED and requires implementation of a Universal Device Identifier as a means to track medical devices across the EU.[17] The goal of the new Regulation is to create stricter scrutiny for pre-market devices and a stronger post-market surveillance system.

The new Regulation poses several problems for countries such as South Africa. The Regulation was created to harmonize the European market and correct differing interpretations of the Directive from a regulatory perspective. The Regulation also provides a legal basis for member states to address issues of fraudulent medical devices and to assure a timely recall of defective devices. Countries which implement the EU’s standards while a non-member state gain all of the teeth of the new Regulation without enjoying its benefits. For example, a device which is recalled under the Regulation may be tracked by its Universal Device Identifier through EUDAMED; however, if that device found its way out of the EU and into South Africa, there is no way to assure that the South African device recipient could be notified of the potential health risk.

Should South Africa amend its new medical device regulation to maintain its congruence with the EU? It may not be prudent for South Africa to continue its regulatory alignment with the EU, post-Brexit. For example, as of 2013 almost 11% of medical devices in South Africa were imported from the United Kingdom.[18] An additional X% are imported from France and the Netherlands,[19] countries that now have political factions questioning whether the benefits of EU membership outweigh the costs.[20] Additionally, as South Africa increasing relies on medical devices developed by non-EU countries such as China and India,[21] reliance on an EU-dependent regulatory scheme such as the Medical Device Regulation does not make sense from a manufacturer’s point of view.

The nation of South Africa thus faces two choices: amend its current regulation to stay in alignment with the EU’s Medical Device Regulation or continue its independent medical device regulation development. The South African government should choose the path which meets the needs of that country’s health system, local device manufacturers, and which will grow its economy according to local political and social normative values.

[1] See, Medical Device Definitions, WHO www.who.int/medical_devices/defintions/en/ (Aug. 2014).

[2] Id.

[3] Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 Geo. Wash. L. Rev. 449, 459 (2008).

[4] About, International Medical Device Regulators Forum, http://www.imdrf.org/about/about.asp (last accessed Feb. 27, 2017).

[5] Id.

[6] South African Medical Device Industry Association, The South African Medical Device Industry – Facts, 8-10 (2014) http://www.samed.org.za/DynamicData/LibraryDownloads/224.pdf.

[7] Id. at 8.

[8] Global Product Liability Guide: South Africa, DLAPiper, http://www.dlapiperproductliability.com/countries/south-africa.html (last accessed Feb. 27, 2017).

[9] Medicines and Related Substances Act of 1965 (S. Afr.). See also, South Africa Medical Device Regulatory Strategy Report, EmergoGroup, https://www.emergogroup.com/services/south-africa/south-africa-regulatory-strategy (last accessed Feb. 27, 2017).

[10] Stewart Eisenhart, New Medical Device Registration Requirements Issued in South Africa, South Africa medical device QA/RA blog (Dec. 14, 2016) https://www.emergogroup.com/blog/2016/12/new-medical-device-registration-requirements-issued-south-africa

[11] Id.

[12] Id.

[13] Id.; South African Medical Device Industry Association, supra note 6, at 8.

[14] Commission Regulation 2017/745 of April 5, 2017, Medical devices, 2017 O.J. (L 117) http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=OJ:L:2017:117:TOC

[15] New Medical Devices Regulation now published, BSI Group (last accessed December 1, 2017) https://www.bsigroup.com/en-GB/medical-devices/our-services/MDR-Revision/

[16] Regulation, supra note 14, at Para. 19.

[17] Id.

[18] South African Medical Device Industry Association, supra note 6.

[19] Id. at 10.

[20] Matthew Holehouse, The Brexit contagion: How France, Italy and the Netherlands now want their referendum too, Telegraph (June 23, 2016) https://www.telegraph.co.uk/news/2016/06/23/the-brexit-contagion-how-france-italy-and-the-netherlands-now-wa/.

[21] Id .; South African Medical Device Industry Association, supra note 19.