Unlike with medicines, and with a few exceptions, South Africa’s regulator does not assess whether diagnostic tests and other medical devices are safe and work as they are supposed to. However, steps are being taken that should eventually lead to their regulation, writes Catherine Tomlinson for Spotlight.
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 are used briefly and then disposed of after a single use, while others are designed to stay in our bodies for long periods, like implants to prevent pregnancy and pacemakers.
Most are used in medical settings, but some, like bandages, thermometers, condoms, and blood pressure monitoring devices, are used at home.
The World Health Organisation estimates that there are more than 2m types of medical devices used around the world.
Because they are sold for medical purposes, they require regulatory oversight to ensure 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 organisation engaged in the development of diagnostics for low-resource settings, 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”.
“Unfortunately, that’s not the case. I have had people sharing stories of life-threatening situations because of inaccurate readings from continuous glucose monitors (CGMs),” she said.
To address the challenge of poor-quality CGMs on the market, South African diabetes advocates and FIND launched a tool to assist diabetics 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 devices used in this 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 them. The relevant legal requirements were introduced in the 2015 Medicines and Related Substances Amendment Act 14. Before this came into force in 2017, only electromagnetic or radiation-emitting medical devices were regulated here.
The 2015 amendments provided for SAHPRA to replace the Medicines Control Council as the health products regulator and expand its scope to cover all medical devices.
SAHPRA’s first big move was to introduce requirements for medical device companies to be licensed as medical device establishments, in a Government Gazette notice issued in 2017. (Manufacturers of the lowest risk products – Class A devices that don’t have a measuring function and/or are not required to be sterile – are currently exempt from the requirements.)
Today, more than 2 500 companies hold active medical devices establishment licences from SAHPRA. In their applications, they must list the devices that they will manufacture, import, or wholesale in South Africa and the establishment licences that they are granted are specific to that class of products.
The devices are classed in four groups, based on their risk to patients and the broader public health. Bandages, for example, are low risk, while heart valves are high risk. Using a risk-based approach allows SAHPRA to harmonise how these are regulated in South Africa with international norms.
In addition to listing the devices they manufacture, distribute, or wholesale, companies seeking medical device establishment licences must also provide a declaration regarding their quality management systems.
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 medical devices are used in the country. And while more than 2 000 companies hold active medical device establishment licences, a single company may be importing more 100 products.
She noted that as regulatory requirements have increased, some companies have voluntarily withdrawn from the market.
ISO 13485 certification
SAHPRA’s second big move, now being rolled out, is the introduction of requirements for these 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.
When SAHPRA first introduced medical device establishment licences, it did not require companies to have ISO 13485 certification – it was concerned that enforcing this too quickly could disrupt access to devices. This was partly due to the lack of local conformity assessment bodies accredited by the SA National Accreditation System (SANAS) to grant this certification at the time.
John Ndalamo, accreditation manager for SANAS’ certification programme, told Spotlight six local conformity assessment bodies have now been accredited to provide ISO 13485 certification.
SAHPRA now requires that companies renewing their five-year establishment licences provide either proof of ISO 13485 certification or evidence that they have begun the process of seeking this certification.
What about regulation of the actual devices?
While important strides have been made by SAHPRA toward regulating medical devices, these still remain mostly unregulated.
What this means, as pointed out by SA Diabetes Advocacy, is that they may currently be marketed here without an independent regulator confirming they are safe to use and perform as advertised.
To register the more than 200 000 devices in use here will be a mammoth job, and Mathibe said that when SAHPRA introduces requirements for this registration, it will be done in a phased, transitional manner. She said the call-up of devices for registration would 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 the devices, and companies holding medical device establishment licences have been asked to voluntarily participate.
In documentation published for the feasibility study, SAHPRA said it plans to include in the study 32 devices used for HIV and TB.
These will cover in vitro diagnostic tests, condoms, and X-ray devices for TB screening.
SAHPRA also wants half of the products included in the study to be manufactured locally and the other half to be imported. This way, it 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.
How safety, performance will be assessed
Mathibe said SAHPRA will not directly assess the safety and performance of the devices in the feasibility study. Instead, this will be done by accredited conformity assessment bodies – 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 here.
For 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 these assessments and marketing approvals, using this information to help make its own decisions.
Devices 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 this country.
Emergency authorisation of Covid-19, mpox devices
In 2020, SAHPRA introduced rules for emergency authorisation listings for certain medical devices used for Covid-19, and then also announced in 2024 that diagnostic tests for mpox required approval from SAHPRA before they could be used here.
It has thus “listed” multiple Covid-19 tests and two mpox diagnostic tests as approved for use in South Africa, under interim Section 21 authorisation.
Khanyisile Nkuku of SAHPRA’s medical devices unit said that while South Africa has had relatively few mpox cases, it is a leading supplier of in vitro diagnostics to the rest of the continent, including those facing large mpox crises, and is working with the African Medicines Regulatory Harmonisation programme to review mpox diagnostics.
See more from MedicalBrief archives:
Medical device regulation in SA is a ‘tangled web’
UCT call on SAHPRA to revisit single-use medical device ruling
Covid-19 exposes SA’s ‘covert’ crisis in the medical device sector