The imperative for medical device regulation to ensure safety and efficacy in healthcare

style="font-weight: 400;">over 2,500 companies hold active medical devices establishment licences from Sahpra. In their applications for these licences, companies must list the medical devices that they will manufacture, import or wholesale in South Africa, and the establishment licences that they are granted are specific to the class of products that they are manufacturing or handling.

Medical devices are classed in four groups from lowest to highest risk products, based on the risk posed by the product to patients and the broader public health. Bandages, for example, are classed as low risk, while heart valves are classed as high risk. Using a risk-based approach allows Sahpra to harmonise how medical devices are regulated in South Africa with international norms and will allow the regulator to prioritise the review of high-risk products as it phases in requirements for registration of medical devices used in the country.

In addition to listing the devices that they manufacture, distribute, or wholesale, companies seeking medical device establishment licences from Sahpra are also required to provide a declaration regarding the quality management systems that they have in place.

Critically, however, the devices themselves are not yet being assessed by Sahpra.

Dr Dimakatso Mathibe, senior manager of Sahpra’s medical device unit, told Spotlight that more than 200,000 different medical devices are used in South Africa. While over 2,000 companies hold active medical device establishment licences, she explained that a single company may be importing over a hundred products. She noted that as Sahpra has increased the regulatory requirements for operating in South Africa, some medical device companies have voluntarily withdrawn from the market.

ISO 13485 certification

Sahpra’s second big move, which is now being rolled out, is the introduction of requirements for medical device companies to gain ISO 13485 certification verifying that they meet international quality management standards.

Medical device companies operating in South Africa can receive certification that they meet ISO 13485 standards from an international or local conformity assessment body that has been accredited to provide this certification.

When Sahpra first introduced medical device establishment licences, it did not require companies to have ISO 13485 certification, as it was concerned that enforcing this too quickly could disrupt access to medical devices in the country. This was in part due to the lack of local conformity assessment bodies accredited by the South African National Accreditation System (Sanas) to grant this certification at the time.

John Ndalamo, accreditation manager for Sanas’ certification programme, told Spotlight that six local conformity assessment bodies have now been accredited to provide ISO 13485 certification.

Sahpra now requires that companies renewing their five-year medical device establishment licences provide either proof of ISO 13485 certification or evidence that the company has begun the process of seeking this certification.

What about regulation of the actual devices?

While important strides have been made by Sahpra toward regulating the medical device industry, medical devices themselves still remain mostly unregulated in South Africa.

What this means is that, as pointed out by SA Diabetes Advocacy, medical devices may currently be marketed in the country without an independent regulator confirming that they are safe to use and perform as advertised.

The registration of the more than 200,000 medical devices in use in the country is a mammoth job. Mathibe said that when Sahpra introduces requirements for the registration of medical devices, it will do so in a phased and transitional manner. She explained that the call-up of medical devices for registration will probably be phased by product risk classes and conditions. Presumably, Sahpra will start with the highest risk products and work down from there.

Assessing feasibility

Sahpra is conducting a feasibility study of its intended approach to register medical devices. Companies holding medical device establishment licences have been asked to voluntarily participate in the study.

In documentation published for the feasibility study, Sahpra indicated it plans to include 32 medical devices used for HIV and TB in the study. These will cover in vitro diagnostic tests, condoms and X-ray devices used for TB screening.

Sahpra also aims for half of the products included in the study to be manufactured locally, and the other half to be imported. In doing so, Sahpra can use the study to test its approach for registering products that are evaluated locally, as well as products assessed in other countries with which it has a regulatory reliance mechanism in place (meaning it can rely on regulatory evaluations performed in these countries).

How will safety and performance be assessed in the feasibility study?

Mathibe said that Sahpra will not directly assess the safety and performance of medical devices in the feasibility study. Instead, this will be done by accredited conformity assessment bodies, which is the same approach used by regulators in Europe. The assessment made by the conformity assessment bodies will then be used by Sahpra in determining whether a product should be approved for use in the country.

For medical devices already registered in jurisdictions with which Sahpra has a reliance mechanism in place, like the European Union, Australia, and Japan, companies can submit evidence of such conformity assessments and marketing approval. Sahpra can then use this information to help make its own registration decisions.

Devices that are not approved by a regulatory authority recognised by Sahpra must undergo a safety and performance assessment by a locally accredited conformity assessment body.

Mathibile said insights from the study will be shared with stakeholders next year, and the lessons will help inform how Sahpra introduces medical device registration in South Africa.

Emergency authorisation of Covid-19 and Mpox medical devices

While Sahpra has not yet registered medical devices, it introduced rules in 2020 for emergency authorisation listings for certain medical devices used for Covid-19 in South Africa, and it announced in 2024 that diagnostic tests for Mpox required approval from Sahpra before they could be used in the country.

Sahpra has thus “listed” multiple Covid-19 tests and two Mpox diagnostic tests as approved for use in South Africa. Khanyisile Nkuku of Sahpra’s medical devices unit told Spotlight that the diagnostic products for Covid-19 and Mpox received interim Section 21 authorisation.

Section 21 authorisation allows for the use of unregistered products under certain conditions, including public health emergencies. This mechanism has been used by Sahpra both to respond to the public health needs posed by Covid-19 and Mpox and to prevent the use of substandard products, which was a challenge faced in the early days of Covid-19.

Nkuku added while South Africa has had a relatively low number of Mpox cases, South Africa is a leading supplier of in vitro diagnostics to the rest of the continent, including countries facing large Mpox crises, and so Sahpra shares the responsibility of ensuring that Mpox diagnostics used on the continent work properly and is working with the African Medicines Regulatory Harmonisation programme to review Mpox diagnostics. DM 

This article was first published by Spotlight — health journalism in the public interest. Sign up to the Spotlight newsletter.