Medical Device Registration in Saudi Arabia

Saudi Arabia is a monarchical state with large oil reserves and is one of the leading members of OPEC. It is an oil-based economy and the government controls most major economic activities. Due to the low oil prices, the government is focusing on expanding its healthcare, education, nuclear, construction, and tourism industries. It is the third-largest recipient of FDI in Western Asia. With its land area of 2250000 square kilometers is one of the largest countries in the Middle East, consisting of mostly desert and huge subterranean reserves of oil. It is the leading member of OPEC. Its population is 27 million, including 8.4 million foreign residents.

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 The two factors that affect healthcare services are the large percentage of foreign workers in the country and the high percentage of young people. So demographics profoundly affect the future shape and direction of the Saudi healthcare system. Medical device registration in Saudi Arabia needs MDMA approval. The national regulatory authority agencies responsible for healthcare in Saudi Arabia are the Ministry of Health (MoH) & Saudi Food & Drug Authority.

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Operon Strategist is a medical device consulting company that provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.

The Kingdom of Saudi Arabia is one of the largest markets for medical devices and associated products in the Middle East region. As part of the Gulf Cooperation Council (GCC, also known as the economic union of the six Arab states), Saudi Arabia has experienced extraordinary growth, primarily due to its hydrocarbon-based economy. The results of this rapid progress can be seen not only in the increasing number of the Saudi population but also in healthcare expenditure. The national regulatory authority agencies responsible for healthcare in Saudi Arabia are the Ministry of Health (MoH) & Saudi Food & Drug Authority (SFDA). The Saudi Food & Drug Authority (SFDA) is the government agency that regulates drugs and medical devices in Saudi Arabia. The Medical Device Sector has three responsibilities: legislative, executive, and surveillance. As to the first, the sub-agency sets mandatory specifications for medical devices, IVDs, and radiation-emitting electronic devices; set good manufacturing practices; issues policies and procedures for medical device testing; sets requirements for medical devices marketing and distribution, and provides advertising regulations. The Authority’s objective is to ensure the safety of food and drug for man and animal and the safety of biological and chemical substances as well as electronic products. The main purpose of the Saudi Food and Drug Authority establishment is to regulate, oversee and control food, drug, and medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. The control and/or testing activities can be conducted in the SFDA or other agencies’ laboratories. Moreover, the SFDA is in charge of consumers’ awareness on all matters related to food, drug and medical devices, and all other products and supplies.

Saudi Food and Drug Authority (SFDA) looks after the safety of food, the safety, quality, and effectiveness of drugs, and the safety, quality, effectiveness, and performance of medical devices according to the intended purpose. And also has a responsibility of SFDA, whether they are imported or locally manufactured. The control and/or testing activities can be conducted in the SFDA or other agencies’ laboratories. Moreover, the SFDA is in charge of consumers’ awareness on all matters related to food, drug and medical devices, and all other products and supplies.

Saudi Food and Drug Authority (SFDA) has issued various guidelines to maintain the safety and performances aspect of medical devices. Medical Device Marketing Authorization (MDMA) approval from the SFDA is required before placing a product on the market. MDMA is an electronic system that aims to authorize medical devices after they comply with the Medical Devices Interim Regulation (MDIR) and in particular to the implementing rule MDS-IR6 for Medical Device Marketing Authorisation (MDMA).

Who Can Enrol?

Manufactures of medical devices
Exporters and importers of medical devices
Distributors/vendors of medical devices

Medical device Registration in Saudi Arabia requires prior approval in one of the following reference markets: Australia, Canada, Europe, Japan, or the USA. Generally, your medical device or IVD classification in the reference market will determine how the SFDA classifies your device. An authorized person should be appointed in Saudi Arabia, as he must have an authorized representative and must obtain a representative license, and renew it on an annual basis, Submitting all documents  and application to the required authority  and representing you in the Kingdom of Saudi Arabia.

You must also appoint a Saudi Arabia Authorized Representative if you do not have an office or entity in Saudi Arabia. Your Authorized Representative must obtain an Authorized Representative License, which is renewable on an annual basis, to legally represent you in the KSA(Kingdom of Saudi Arabia). Your KSA Authorized Representative is also responsible for submitting all application documents to the SFDA to register your device. Medical device manufacturers without a legal entity in the Kingdom of Saudi Arabia (KSA) must appoint a Saudi Arabia Authorized Representative who serves as a liaison between you and the Saudi Food & Drug Authority (SFDA), They actually protect your intellectual property and allow you to control your distribution options.

How to Enroll for Medical Device Registration in Saudi Arabia ?

Enrolment is online and only limited relevant information will be required. It consists of two main steps

Step 1: Account Creation

Step 2: Establishment Enrolment

Section A: Establishment Information

Section B: Authorized Person for the Establishment

Section C: Medical Devices Information

Section D: Post-Market Requirements

Section E: Post-Market Requirements

What Documents are required for MDNR( Medical Device National Regulatory) ?

1) Documents required for Section A

Business Registration Certificate.

Chamber of Commerce Certificate.

2) Documents required for Section B

National Identity or Iqama.
Official authorization letter from the Owner stamped by the company and approved by the Chamber of Commerce and Industry or legal authorization letter from the Court.

3) Documents required for Section C

Products Certificates such as “FDA, ISO, CE, .etc.”.

4) Documents required for Section D

Quality System Certificate if available.

5) Documents required for Section E

Declaration Form stamped and signed by the authorized person and approved by the Chamber of Commerce & Industry.

We have an impressive portfolio with existing industry giants which makes us competent for undertaking any project. We ensure your manufacturing unit is suitable for all National/International regulatory norms and expected audits. we already have completed and have some projects in progress at various global locations. Our Online Screen Sharing module facilitates effective training of the individuals of the organization. Project deliverables and timelines are tracked/handled through meticulous planning by our team.

References: https://mdma.sfda.gov.sa/