Saudi Arabia is an emerging market for medical device manufacturers. The country is heavily invested in improving its healthcare infrastructure and patient care services. Additionally, Saudi Arabia is focussed on strengthening its medical device industry. Thus, Saudi Arabia is a lucrative market for medical device manufacturers. Moreover, the country is streamlining its regulations for medical devices. It is aiming to develop a strong and comprehensive medical device regulatory policy. The policies focus not only on device quality and efficacy but also on improving market access for manufacturers. In this blog, we have highlighted why should you start a medical device manufacturing unit in Saudi Arabia.

Saudi Arabia offers a unique environment for establishing medical device manufacturing units. To market medical devices in Saudi Arabia, registration with Saudi Food and Drug Administration (SFDA) is mandatory. The SFDA medical device registration process has extensive guidelines, documentation requirements, and rigorous quality standards. Furthermore, the guidelines provide an understanding of the requirements for manufacturing, advertising, and distributing medical devices in Saudi Arabia.

Why set up a medical device manufacturing unit in Saudi Arabia?

Saudi Arabia is strategically located for setting up a medical device manufacturing facility. It is the gateway to the Middle East and North African region as well as has close proximity to European and Asian regions. Hence, starting a medical device manufacturing unit in Saudi Arabia will open up global export opportunities, thereby offering a prime location for companies seeking to expand internationally. Notably, Saudi Arabia is prioritizing indigenous manufacturing in the medical device sector. Moreover, to encourage domestic medical device production, the government has introduced several schemes.

6 reasons for setting up medical device manufacturing unit in Saudi Arabia

1. Government subsidies: The Saudi Arabian government is providing financial support to medical device manufacturers. Subsidized loans are being granted. The government grants will help cover operational costs, research and development expenses, and cost for setting up infrastructure.
2. Land and infrastructure support: Saudi Arabia is offering industrial lands at extremely subsidized rates. Moreover, medical device manufacturers will be provided access to world-class infrastructure, including central labs and testing facilities.
3. Streamlined regulatory framework: The SFDA provides a clear streamlined regulatory framework for approval of medical device in Saudi Arabia. The regulatory guidelines have been formulated to help medical device manufacturers efficiently market their products in Saudi Arabia while maintaining high safety and quality standards.
4. Technological advancements and skilled workforce: Saudi Arabia is investing in technological advancements to foster research and development in the medical device industry. The country is setting up state-of-the-art manufacturing facilities to meet international standards. Moreover, the number of skilled engineers, technicians, and healthcare professionals is growing in the country. Additionally, they are trained to operate advanced machinery and implement the best practices in medical device production.
5. Tax exemptions: Manufacturers planning to set up medical device manufacturing unit in Saudi Arabia will be provided tax exemptions and benefits. Additionally, they will have the privilege of reduced corporate tax rates, thereby have benefits of long-term investment.
6. Priority to locally manufactured medical devices: The government is pushing public and private healthcare facilities to purchase locally manufactured medical devices. To boost local medical device manufacturing, the government is prioritising procurement of locally-made devices.

Government support for locally manufacturing medical devices in Saudi Arabia

Saudi Arabia is prioritising self-reliance in the medical device sector. The government has launched various schemes to boost local medical device production. Moreover, it is supporting infrastructural development. Furthermore, it is fostering an environment conducive for research and development in the medical device sector. Thus, it is becoming viable to set up a medical device manufacturing unit in Saudi Arabia. Saudi Arabia is aiming to become a medical device manufacturing hub that will cater to not only the domestic demands but also be able to export to global markets. The government is taking the following proactive steps:

• Government subsidies: The government is offering financial support to medical device manufactures in way of subsidized loans. Also, the government is helping manufacturers cover initial investment costs, research and development expenditure, and operational expenses.
• Tax exemptions: Tax exemptions for a certain number of years for domestic medical device manufacturers.  
• Land access: The government is providing medical device manufacturers access to industrial lands at subsidized rates.
• Central laboratories: The government has taken the initiative of establishing centralised labs.  Centralised labs will be used by manufacturers to test and validate their medical devices for ensuring they meet global quality benchmarks.

Regulations for setting up medical device manufacturing unit in Saudi Arabia

The Saudi Arabia medical device regulations are dynamic and are constantly being updated to protect patient health. The first step for setting up a medical device manufacturing unit in Saudi Arabia is to comply with SFDA guidelines. The Saudi Arabia medical device registration process will depend on the medical device class. There are two primary SFDA medical device registration pathways.

1. Medical Device National Registry (MDNR) listing: For non-sterile/non-measuring low risk medical devices, listing in the Medical Device National Registry (MDNR) is required as a pre-requisite for marketing the device in Saudi Arabia. This listing can be done by any establishment importing or distributing the device in the country. Basic product and manufacturer information, proof of QMS, and reference country approval are required. Additionally, device labelling and marketing materials are also required. The SFDA usually grants approval in 4 working days. Furthermore, this approval is valid for 3 years.
2. Medical Device Marketing Authorization (MDMA): For all other classes of devices, medical device approval issued as Medical Device Marketing Authorization (MDMA) is required to market the device in Saudi Arabia. The SFDA medical device registration timeline for the MDMA approval is usually 35 days. Furthermore, the license will remain valid for the period of original license validity or 3 years for undefined original license validity.

What is the Saudi Arabia medical device registration process?

1. Medical device classification
2. Technical file and supporting document preparation
3. Foreign manufacturers to appoint an authorised representative
4. File the application online
5. SFDA will review the application and evaluate the documents
6. If applicable, SFDA will review the clinical data to assess the device’s safety and effectiveness
7. If applicable, SFDA will review the manufacturer’s compliance with relevant quality management standards
8. If the SFDA is satisfied with the documentation, assessments, and audits, they will issue a medical device registration certificate
9. Once the device is registered, manufacturers must comply with post-market surveillance and reporting requirements

Why choose Pharmadocx Consultants as your Saudi Arabia medical device registration consultant?

We possess in-depth knowledge of the Saudi Arabia medical device regulations. We will help identify the correct medical device class, prepare documents, file the application, prepare query response and provide assistance till you successfully secure your registration. Moreover, our support does not end with successful SFDA medical device registration. We also provide post license approval support and guidance. We provide the following services:

1. SFDA regulatory assistance
2. QMS implementation
3. Technical file and supporting document preparation
4. Prepare timely and correct SFDA query response
5. Follow up until SFDA regulatory approval is granted

Planning to set up medical device manufacturing unit in Saudi Arabia? Our aim is to help you secure swift and efficient SFDA approval. Drop an email at [email protected] or call/Whatsapp on 9996859227 for hassle-free medical device registration in Saudi Arabia. We tailor our services per client needs.