Medical Devices Aren’t Regulated in SA, but that is Set to Change
By Catherine Tomlinson
Unlike with medicines, and with a few exceptions, South Africa’s regulator does not assess whether diagnostic tests and other medical devices on the market are safe and work as they are supposed to. The regulator has however started down a road that should eventually lead to the regulation of all medical devices in the country.
From scalpels to surgical robots, finger-prick diagnostic tests to MRIs, thermometers to wearable AI-powered health monitoring devices, bandages to prosthetics: the range of products classified as medical devices is vast.
Some medical devices are used briefly and then disposed of after a single use, while others are designed to stay in our bodies for long periods of time, such as implants to prevent pregnancy and pacemakers to help the heart beat regularly.
While most medical devices are used in medical settings, some, like bandages, thermometers, condoms, and blood pressure monitoring devices, are used at home.
The World Health Organization estimates that there are more than two million different types of medical devices used around the world. Given the enormous diversity of medical devices, it can be tricky to see what links all these products together.
One answer, and essentially the one used in South African law, is that it is the intended use of the device. A medical device is thus simply any device that is intended to be used to prevent, diagnose, monitor, or treat a disease, injury, or other medical condition.
Because medical devices are sold for medical purposes, they require regulatory oversight to ensure that they are safe to use and work as intended. But in South Africa, this regulatory oversight is not yet fully in place, and you can’t always trust that devices do what they claim to do, or that tests are accurate.
‘Inaccurate readings’
On a recent webinar hosted by FIND, an international non-profit engaged in the development of diagnostics for low resource settings, the chairperson of NGO SA Diabetes Advocacy, Kirsten de Klerk, told participants that “a lot of people assume that if a medical device is available for purchase, it has been correctly tested and approved for use” but “unfortunately, that’s not the case”.
De Klerk added: “I have unfortunately had community members sharing stories of life-threatening situations because of inaccurate readings” from continuous glucose monitors (CGMs). These are medical devices used by people with diabetes to monitor their blood sugar level.
To address the challenge of poor-quality CGMs on the market, South African diabetes advocates and FIND launched a tool to assist people with diabetes and healthcare providers to identify and use monitors that have been properly assessed for safety and functioning.
But what role does the South African Health Products Regulatory Authority (SAHPRA) play in ensuring the safety and effectiveness of medical devices used in the country, and what steps is it taking to better protect the public?
A mandate to regulate
Though medical devices aren’t yet registered, SAHPRA does have a legal mandate to regulate medical devices. The relevant legal requirements were introduced in the 2015 Medicines and Related Substances Amendment Act 14. Before the 2015 Amendment Act came into force in 2017, only electromagnetic or radiation-emitting medical devices were regulated in South Africa.
The 2015 amendments provided for the establishment of SAHPRA to replace the Medicines Control Council as the country’s health products regulator and expanded SAHPRA’s regulatory scope to cover all medical devices.
SAHPRA’s first big move towards regulating the medical device industry was to introduce requirements for medical device companies to be licensed as medical device establishments. Medical device companies were informed that they would need a medical device establishment license to operate in the country in a government gazette notice issued in 2017. (Manufacturers of the lowest risk products – Class A medical devices that don’t have a measuring function and/or are not required to be sterile – are currently exempt from the licensing requirements.)
Today, over 2 500 companies hold active medical devices establishment licenses from SAHPRA. In their applications for these licenses, companies must list the medical devices that they will manufacture, import, or wholesale in South Africa and the establishment licenses 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 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 licenses 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 two thousand companies hold active medical device establishment licenses, 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 licenses, 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 licenses 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 over 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 likely 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 licenses 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.
Republished from Spotlight under a Creative Commons licence.
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