Leveraging your 510(k) in the Saudi Arabia regulatory landscape

by | Jun 13, 2024 | IMed Consultancy, MDR, New Markets

New markets - Mexico

Understanding how US approvals may support market entry into Saudi Arabia

The landscape of medical device regulations has seen major changes in the last few years, with different countries taking a different approach to developing a framework that ensures the safety and efficacy of medical devices. For manufacturers, understanding these regulations is crucial to successfully place and maintain their devices in new markets. One market of particular interest is Saudi Arabia, known for its attractive growth potential in the medical device industry. This blog explores whether manufacturers can leverage US medical device approvals, particularly the 510(k) clearance, to expedite their entry into the Saudi market.

The US 510(k) pathway: a benchmark for simplicity

The US regulatory framework for medical devices, particularly the 510(k) pathway, is renowned for its relative simplicity. Under the 510(k) process, manufacturers must demonstrate that their device is substantially equivalent to a legally marketed device. This contrasts with the more stringent requirements of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), making the US an attractive first market for new products, as discussed in our blog series dedicated to market entry.

Given the straightforward nature of the US system, manufacturers may seek to leverage US approvals in other markets. Countries like Australia, New Zealand, India, South Africa, Taiwan, Singapore, Israel, and Mexico have regulatory frameworks that recognize US approvals to some extent, facilitating easier market entry.  But what about Saudi Arabia?

Saudi Arabia’s medical device market: an overview

Saudi Arabia, officially known as the Kingdom of Saudi Arabia (KSA), presents a compelling opportunity for medical device manufacturers. With a population exceeding 36 million and a healthcare system undergoing rapid modernization and expansion, the demand for medical devices is robust. The market value for medical devices in Saudi Arabia is expected to reach US$6.55bn in 2029, and US$8.30bn in 2029, with a CAGR of 4.85%[2], driven by government initiatives to enhance healthcare infrastructure and services.

Regulatory Landscape in Saudi Arabia

The regulatory framework in Saudi Arabia is governed by the Saudi Food and Drug Authority (SFDA). Established in 2003, the SFDA has developed comprehensive regulations to oversee the safety and efficacy of medical devices.

In 2008, the SFDA published the Medical Devices Interim Regulation (MDIR)[3], marking the introduction of a regulated market for medical devices in Saudi Arabia. One of the key requirements under the MDIR was for manufacturers to obtain an authorized representative within the KSA and provide documentation demonstrating compliance with the regulations of one of the Global Harmonization Task Force (GHTF) founding member jurisdictions, which includes the US. This provision allowed manufacturers to leverage US approvals and clearances, such as the 510(k), to facilitate device registration in Saudi Arabia.

However, the regulatory landscape has since evolved. In 2021, the SFDA issued the Implementing Regulation of the Law of Medical Devices[4], which introduced new requirements for medical device classification and authorization. This regulation mandates that all medical devices be classified according to risk levels:

  • Low Risk (A)
  • Low to Medium Risk (B)
  • Medium to High Risk (C)
  • High Risk (D)

To obtain a Medical Device Marketing Authorization (MDMA), manufacturers must classify their devices according to these categories and submit the necessary documentation through an e-submission system. This includes a technical file for review and proof of a quality management system, in line with article 22.

Notably, the acceptance of the GHTF route, which allowed the leveraging of US approvals and clearances, was extended through a transition phase until January 1, 2022. Post this date, manufacturers must comply with the new regulatory requirements to gain MDMA. This means that while US approvals can still play a role, they are no longer sufficient on their own to expedite market entry.

Implications for manufacturers

The regulatory framework in Saudi Arabia has therefore become more stringent, reflecting the country’s commitment to ensuring high-quality medical devices for its population. While this is positive for patient safety and the medical device industry in the long term, manufacturers can no longer rely solely on US 510(k) clearances for swift market entry.

To navigate this landscape, manufacturers must:

  1. appropriately classify devices: understand the risk classification of their devices according to Saudi regulations.
  2. prepare comprehensive documentation: ensure that all required documents, including technical files and quality management system proofs, are ready for submission.
  3. engage authorized representatives: work with authorized representatives within Saudi Arabia to facilitate the registration process.

Saudi Arabia’s regulatory environment for medical devices has matured significantly, prioritizing safety and quality. Although no longer a fast-track into the Saudi market, US approvals and clerances like the 510(k) can provide a solid foundation. Manufacturers should engage with regulatory professionals that are able to consolidate compliance efforts across international markets to avoid duplication of tasks. This strategic approach will not only align with regulatory demands but also contribute to ensuring that compliance is taken care of in a holistic and efficient manner, expediting international expansion.

[1] Statista, Medical Devices – Saudi Arabia

[2] Statista, Medical Devices – Saudi Arabia

[3] SFDA, Medical Devices Interim Regulation

[4] SFDA, Implementing Regulation of the Law of Medical Devices

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