Medical Device Manufacturing in Emerging Markets

A report produced by BMJ for ITC

Transforming my daily clinical practice case study

Overview

Emerging markets have steadily become increasingly important in medical device manufacturing as companies seek lower production costs, faster access to growing healthcare demand, and more resilient supply chains. It is an industry that operates globally and is thus driven by complex and competing factors, in particular regulation and trace demands. The market is truly international as development often happens in one market, manufacturing in another and usage somewhere different again.

This work was made possible by ITC’s UKTP Programme, with funding from the UK’s FCDO.

In focus

Manufacturing decisions cannot be separated from regulation

Limited commercial value if a company cannot secure the required manufacturing licence, maintain an accepted quality-management system.

Overseas manufacturers must be aware of the regulations in the export and import countries.

Patient safety, quality and efficacy is paramount

Labour practices and environmental impact are aspects of regulation that cannot be ignored

Why this matters

Regulation matters because patient safety is paramount and medical devices must be safe, effective, and reliable before reaching the market.

It ensures consistent quality, proper oversight, and trust in products used in healthcare settings.

It also matters beyond the product itself, by addressing labour conditions, environmental impact, and ethical supply chains.

In global procurement, this helps ensure devices are not only compliant, but also produced responsibly and without avoidable harm.

Who should read

ESG and sustainability officers

Procurement and supply chain managers

 

Healthcare managers and executives

Regulatory affair professionals

Policy Advocates

Further reading

Device regulation UK
Learn more > 

Medical Device Management file: Krämer, A., Franco, C., Chamorro, I.P., Bogdanov, G. (2026). International Markets and Developments for Medical Devices. In: Krämer, A., Franco, C., Hartung-Linz, F., Thom, E. (eds) Medical Device Management. Springer Series in Healthcare Management and Innovation. Springer, Cham.
Learn more >

Trueba ML, Bhutta MF, Shahvisi A. Instruments of health and harm: how the procurement of healthcare goods contributes to global health inequality Journal of Medical Ethics 2021;47:423-429.

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