SFDA approval for medical devices

The certificate is the result of an intensive and exclusive cooperation with Batterjee Medical Company. With this company we have a strong partner at our side, offering a wide range of surgical instruments, implants, medical devices and medical consumables.Batterjee Medical Company is known to be a company with a passion for providing the best innovative technology to their customers.

Especially in the field of medical technology, service is the top priority for Batterjee Medical Company. The med-tech division has state-of-the-art, well-equipped workshops, staffed by experienced technicians in all disciplines. The existing structures and the high level of service capability made the decision to establish this cooperation very easy for us.

Saudi Food and Drug Authority

Medical device quality and safety have long been a widespread concern for consumers and relevant authorities in the Kingdom of Saudi Arabia.
Established in 2003 by the Saudi Council of Ministers, the Saudi Food and Drug Authority (SFDA) is responsible for designing and implementing structures to ensure the quality of medical devices nationwide. GIZ supports the SFDA in achieving its goals with its expertise from the German and European sectors. Currently, ENDODOCTOR GmbH has received SFDA approval for medical devices after auditing its product files.

The main purpose of the SFDA facility is to regulate, monitor, and control food, drugs, and medical devices and to establish mandatory standard specifications for these products, whether they are imported or locally manufactured. Inspection and/or testing activities may be conducted at SFDA laboratories or other agencies. In addition, SFDA is responsible for educating consumers on all matters related to medical devices.

The main objectives of the SFDA can be outlined as follows:

  • Monitor the safety, security, and efficacy of medical device foods and drugs for humans and animals.
  • Monitor the safety of complementary biological and chemical substances, cosmetics and pesticides.
  • Monitor the safety of medical devices and their impact on public health.
  • Ensuring the accuracy and safety of medical and diagnostic devices.
  • Approval for medical devices.

The agency is to provide scientific basis for awareness and guidance as well as executive programs in the areas of medical devices, food and drugs. This can be done by recruiting experts and specialists or by partnering with research institutions such as King Abdulaziz City for Science and Technology (KACST) and/or university research centers.

Control and monitor licensing procedures for factories for food, medicines, and medical devices. Disseminate and share information with local and international scientific and legal agencies and establish a database for food and medicines.

Certificate according to annex Annex II – excluding Section 4 of Council Directive 93/42/EEC concerning medical devices