Officially Enforcing Newer Conditions on Import/Manufacture of Medical Supplies

A new system for medical devices and supplies was issued. It is officially enforced after one hundred and eighty days. Strict standards and conditions for marketing, advertising, manufacturing, import and storage activities were set, provided that the Food and Drug Authority undertakes licensing, follow-up, prosecution and review activities.

According to the system, the violating establishment is punished with a fine of not more than SR 5 million, the temporary closure for a period of 180 days, the suspension of the marketing permission for a year, and the prevention of the violator from practicing the activity of selling devices for a period not exceeding 180 days.

The system defines the medical device as every instrument or performance used in diagnosing, preventing, monitoring, controlling, treating, mitigating, or relieving diseases or injuries or used for examination, x-rays, etc.

It is subject to the provisions of the system, the design, marketing and storage of medical devices and supplies, and the approval of the Food and Drug Authority is required.

 It is not permissible to circulate any medical device or equipment except after registration and permission to market. The authority may exclude some of them from the requirement to obtain permission after ensuring their safety and not using them for commercial purposes.

 Medical devices for personal use are permitted based on a medical report in limited quantities, provided they are not used for any commercial purpose. Anyone who sells a device that is fraudulent, counterfeit, or not registered with the Food Authority shall refund its value to the buyer.

The Medical Devices and Supplies Law affirmed that when a factory residing outside the Kingdom wishes to trade its products in Saudi Arabia, the health care provider is obligated not to deal with any facility practicing the profession without a license or registration, and it is not permissible to reprocess the devices that are used once.

It is also not permissible to destroy, repair, or donate them without the approval of the authority, and the system prohibits the dispensing of high-risk medical devices and supplies outside the health care provider’s facility without a prescription.