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.
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 an 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 Ministry of Health (MoH) is the highest-level supervisory board that oversees all aspects of the Kingdom’s healthcare services, and is responsible for building hospitals & health care centers, as well as issuing and enforcing regulations for the practice of medicine and pharmacology.
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 manufacture practices; issues policies and procedures for medical device testing; set requirements for medical devices marketing and distribution, and provides advertising regulations. The Authority objective is to ensure the safety of food and drug for man and animal, and safety of biological and chemical substance as well as electronic products. The main purpose of the Saudi Food and Drug Authority establishment is to regulate, oversee, and control food, drug, 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 agency’s 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 has issued a number of guidelines to assist an organization operating in the field of medical devices to understand its obligations under the Interim Regulation and the Implementing Rules.
The Saudi Food and Drug Authority (SFDA) regulates medical devices and IVDs sold and distributed in Saudi Arabia. For most devices, Medical Device Marketing Authorization (MDMA) approval from the SFDA is required before placing a product on the market. MDMA is an electronic system 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). The system allows local manufacturers and overseas manufacturers authorized representatives to apply electronically for medical devices marketing authorization which permits relevant medical devices to be placed on the market of the Kingdom of Saudi Arabia when satisfied that the applicant has provided all the required information for market authorization. The SFDA meticulously reviews MDMA applications, so prepare your submission carefully to ensure a timely approval.
What is needed before submitting a device registration?
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.
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.
Documentation Required for Submitting applications to the SFDA
All application documents are submitted via the Saudi Arabia’s MDMA system. SFDA submissions must be provided in English, and include the following documentation:
- Manufacturer and KSA Authorized Representative details.
- Medical device information, such as intended use and labeling/instructions for use and all marketing materials.
- Documents supporting your market authorization in the reference market (e.g., CE Certificate, FDA 510(k) Letter, etc.)
- Proof of QMS compliance in your reference market
- Attestations that the device can withstand local environmental factors (e.g., extreme heat), Declaration of Compliance to Saudi regulations, and attestation of electrical compatibility (for active devices).
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