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Regulation and certification remain key for medical devices manufacturing in Africa

24th October 2023

By: Schalk Burger

Creamer Media Senior Deputy Editor

     

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Having harmonised medical devices regulatory regimes across Africa will help to reduce the costs for African manufacturers selling into other markets on the continent and thereby support the growth of Africa's local medical devices manufacturing.

Harmonised regulations will also improve the likelihood of multinationals setting up manufacturing facilities in Africa to sell regionally and for export.

Africa imports more than 90% of the medical devices and consumables it needs, despite having a 125-year history of making medical devices, researchers said during economic research institution Trade and Industrial Policy Strategies (TIPS) Development Dialogue on medical devices on October 23.

The vulnerability of countries in Africa, and worldwide, to disruptions in medical devices supply, such as personal protective equipment and ventilators, was highlighted during the Covid-19 pandemic.

There were several quick potential wins in terms of local manufacturing of medical devices that Africa could achieve, but long-term and sustainable local manufacturing of especially higher technology medical devices required long-term State support and enabling regulatory environments, said consulting firm HolaVic Consulting director Victor van Vuuren.

"During discussions with industry, institutions and government players, it has been made clear that two things are necessary, namely we need to ensure volumes and an enabling environment, and we do not have sufficient of either currently," he said.

South Africa alone could not produce the volumes required to have sustainable successful medical device manufacturing businesses, he emphasised.

Additionally, global competitiveness is one of the core pillars of the South African medical devices industry master plan, and cost and quality are important for businesses to be sustainable and effectively serve the healthcare industry, as well as to readily be able to export to other African countries and worldwide.

Africa should align its regulatory practices to reduce the burden of registration and certification for companies aiming to manufacture and trade in Africa. The regulatory fragmentation was causing more challenges than opportunities for medical device manufacturing in Africa, he added.

Additionally, incentives played a significant role in most countries that have successfully promoted their medical devices sector. They are necessary to increase investment in the sector, and procurement processes must also be employed to support local manufacturing.

However, the medical devices sector encompassed many different industries, including steel, plastics, chemicals and textiles, among others, and the impediments to greater local medical devices manufacturing in Africa were transversal across many different industries, said University College London Science, Technology, Engineering and Public Policy health innovation Professor Julius Mugwagwa.

"There is a need for multiple lobbies and collaboration between multiple sectors as well as government to confront the impediments, which include issues around creating sufficient economies of scale and addressing market access challenges.

"Further, we need to determine how localisation can happen and at the sufficiency and agility required by the market to make higher technology products," he noted.

There was lots of work needed to strengthen the pharmaceuticals and medical devices sectors in Africa. However, while there were 650 facilities manufacturing pharmaceuticals and medical devices in 29 African countries and there were things happening in the sectors, they were not sufficient in terms of the investment needed to match political rhetoric on healthcare, he added.

"There is a lack of sufficiency and the lack of agility in the sector is also an issue. African countries can repurpose some of the existing capabilities to make more medical devices components that are required immediately in the countries and/or their regions while longer-term requirements are addressed," he advised.

Africa produces tablets, powders, injector bowls, sprays, antibiotics and anti-infectives, among others, but, similar to the rest of the world, there is a shortage of active pharmaceutical ingredients (APIs) and little capacity to manufacture APIs in Africa.

"This is a big challenge but also an opportunity for African countries to move into API manufacturing," Mugwagwa said.

Further, the medical devices manufacturing sector has much more complex regulations than other manufacturing sectors, and policy incoherence is a barrier to localisation.

"The issues surrounding access to finances and incentives to grow the nascent sector shows how undervalued this strategic health sector is," he emphasised.

"The sector sits at the confluence of multiple interests, including politics, public health, manufacturing and trade. There is an opportunity for entities across this spectrum to come together and push for a long-lasting and capable sector.

"The growth of medical devices manufacturing will be the result of deliberate efforts, policy creation and trade-offs to develop and sustain the industry. The fledgling medical devices manufacturing sector needs support and standards and finances, but the potential is there.

"While there are lots of weaknesses and limitations, it is an evolving landscape with lots happening in it, and this can be leveraged to build a sustainable, more inclusive and more responsible medical devices manufacturing sector," he said.

Long-term State commitment and providing capital to the sector were key. Bangladesh had done this well, as had India for its pharmaceuticals manufacturing sector, but long-term State commitment was important as the benefits from the sector would not arise overnight, said Mugwagwa.

Meanwhile, many healthcare service providers insist on medical devices certifications that cannot be obtained and local manufacturers have to rely on European or US certification, which comes at a considerable cost for them.

"We need to establish a medical devices certification and standardisation regime for Africa, but, until we can do this, governments should look at subsidising the costs of certification, as they continue to be a barrier," said Van Vuuren.

A potential model to investigate is that adopted by Botswana in its legislation, which is based on the Irish model of medical devices regulation.

"Ireland is the go-to hub for medical devices production and distribution in Europe and has a simple yet effective system. We can use the Botswana model to align the Southern African Development Community countries and use that to provide certification assurances for exports into Africa," he said.

Edited by Chanel de Bruyn
Creamer Media Senior Deputy Editor Online

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