Medical Devices
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The medical device category encompasses a wide range of instruments used in healthcare. These devices can be as simple as a toothbrush or as complex as a pacemaker, and each requires regulatory approval before marketing in most countries.
As with all regulated products, classification of a device is key to ensure a successful and efficient path to market. In all countries, medical device applications are highly specific, and the requirements of an application depend on the classification of the product in the intended market. Depending on the classification and the country, the device license may be associated with the manufacturing or importing facility or with the device itself.
In addition to the type, classification, and complexity of the device, the process, timeline and cost of applying for a medical device license depends on the quality systems in place at the involved facilities and the intended users of the device (personal or professional). In many countries, the manufacturing facility must be licensed by the regulatory authorities of the countries the product will be sold in.
Our team can classify your product, prepare and submit your medical device registration, and ensure your plan-to-market is complete by evaluating your facility, ensuring quality systems are complete and all is in place for a successful launch.
Find a list of our services on the left menu, or contact us for a registration/product categories – a unique service that evaluates your product/process/facility feasibility based on your plan-to-market, providing you with a customized overview of the regulatory processes you can expect for your business.
The Kingdom of Saudi Arabia has been rated in the top 20 most economically competitive countries in the world. With the government investment plans in the Health Care sector & stable economy, Saudi Arabia is always of key interest for international Medical Device Manufacturers planning to enter new markets.
The Kingdom of Saudi Arabia has been rated in the top 20 most economically competitive countries in the world. With the government investment plans in the Health Care sector & stable economy, Saudi Arabia is always of key interest for international Medical Device Manufacturers planning to enter new markets.
Regulatory Standards offers regulatory consultation services to assist our clients comprehend the intent and the sanctions of the Saudi Food & Drug Authority (SFDA) regulations. We can support with getting the appropriate Medical Device classification, approval for Research and Educational purpose devices, and approval for Demonstration and Training purpose devices from the SFDA. As part to our consultation services, Regulatory Standards provides clients with structured & reliable Medical Device Market Research Reports of Saudi Arabia. We can assist with the process of gathering, analyzing and interpreting information about Medical Device market, about a product or service to be offered for sale in that market, and about the past, present and potential customers for your Medical Devices, research into the characteristics, spending habits, location and needs of your business’s target market, the industry as a whole, and the particular competitors you face. Our team is always ready to assist local and foreign parties looking for guidance and support into the Medical Device Sector of Saudi Arabia.
Medical Device Registration in Saudi Arabia is based on companies already having approval in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA; and registration in one of these markets is mandatory in order to register in Saudi Arabia.
Per SFDA process, All medical devices & IVDs intended to be marketed in the Saudi Arabia should have a valid Medical Device Marketing Authorization (MDMA) as per the following enforcement dates.
Our services are based on medical devices regulation in Saudi Arabia in order to ensure your compliance with SFDA.