Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study

ABSTRACT

Introduction

Spinal implants play a vital role in healthcare delivery, and regulations are necessary to ensure their quality, approval, access, and use. In this article, we examine the current state of regulation and approval procedures for medical devices in low- and middle-income countries (LMICs), emphasizing the situation in Tanzania.

Areas covered

We conducted a systematic literature search and interviewed a local spine implant representative to investigate the approval, availability, and access of surgical and spinal implants in LMICs, particularly in Africa. Out of the 18 included articles, six referred to African regulations, with no mention of spinal implants. Our analysis revealed that LMICs face challenges in accessing implants due to affordability, poor supply chain, and lack of expertise for their application. However, surgeons have found alternative solutions, such as using lower-cost implants from Turkish manufacturers. The Tanzania Medical Devices and Drugs Authority oversees the local regulatory and approval process for implants.

Expert opinion

Regulation and accessibility of spinal implants in LMICs, particularly in Africa, are limited and negatively impact patient care and best medical practice. Potential solutions include capacity building within and collaboration among regulatory organizations to improve regulatory processes and allocating financial resources to qualitative and quantitative implant access.

KEYWORDS:

• Spine
• implant
• low- and middle-income countries (LMIC)
• regulation
• medical device
• good manufacturing practice (GMP)

Article highlights

• Spinal implants play a crucial role in healthcare. This article delves into the regulation of medical devices, specifically spinal implants, within LMICs.

• The African region faces challenges in its regulatory processes for medical devices, leading to restricted access to spinal implants because of affordability concerns, supply chain inefficiencies, and a lack of expertise.

• In Tanzania, the oversight of implant approval lies with the Tanzania Medical Devices and Drugs Authority (TMDA), while a Turkish company serves as the source of cost-effective implants.

• Recommendations for LMICs include enhancing regulatory entities, promoting local manufacturing, fostering collaborative standardization, building capacities, and implementing enabling policies.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.