In force
Saudi Medical Devices Law
نظام الأجهزة والمستلزمات الطبية
Regulates medical devices and supplies in Saudi Arabia. It concerns manufacturers, importers, distributors and health facilities that produce, market or use them.
- Articles
- 49
- In force
- 49
- Amended
- 0
- Issued
- 6/7/1442 AH
Issued by: مرسوم ملكي رقم (م/54) وتاريخ 1442/7/6هـ · قرار مجلس الوزراء رقم (377) وتاريخ 1442/7/4هـ
Each article shows the official Arabic text, which is the only legally binding version, followed by our plain-English explanation.
Browse Medical Devices Law by topic
Scope and Definitions of the Medical Devices Law7 articlesRegistration and Licensing of Establishments5 articlesMarketing Authorization for Medical Devices4 articlesImporting and Clearing Medical Devices3 articlesObligations of the Manufacturer and Authorized Representative6 articlesUsing and Reprocessing Medical Devices4 articlesAdvertising Medical Devices2 articlesMedical Device Incidents and Safety Alerts7 articlesInspecting Medical Establishments6 articlesMedical Device Fraud Violations and Penalties4 articlesGrievances Against Authority Penalties and Compensation4 articles
Articles of the Saudi Medical Devices Law
- Article 1The article defines the key terms of the Medical Devices and Supplies Law, such as medical device, medical supply, adulterated, establishment, authorized representative, marketing authorization and safety alert.
- Article 2The article lists eight activities that are subject to the Medical Devices and Supplies Law, from design, manufacturing and importing to maintenance and representing a foreign manufacturer.
- Article 3The article treats accessories of medical devices and supplies, and assembled devices, as medical devices and supplies subject to the Law's provisions.
- Article 4The article requires the Food and Drug Authority to approve the technical and clinical specifications of radioactive medical materials before they are licensed by the Nuclear and Radiological Regulatory Commission.
- Article 5The article preserves the Nuclear and Radiological Regulatory Commission's jurisdiction to issue the license for protection from ionizing radiation emitted by medical devices, without the Law affecting it.
- Article 6The article bars any establishment from practicing the Law's activities except after registration and obtaining a license, with an industrial license for factories, subject to Article 4.
- Article 7The article requires a licensee to obtain the Authority's approval before starting any process of verifying clinical studies, in accordance with the Implementing Regulations.
- Article 8The article bars circulating any medical device or supply before registration and marketing authorization, and allows the Authority to exempt some of them on conditions under rules approved by the Board.
- Article 9The article allows the Authority to exempt an innovative medical device or supply from some marketing authorization conditions and procedures without affecting its safety and security.
- Article 10The article refers to the Regulations the conditions and procedures for registration, issuing the marketing authorization, and for the license and its renewal, amendment, transfer and cancellation.
- Article 11The article bars clearing imported medical devices and supplies except after the approval of the Saudi Food and Drug Authority.
- Article 12The article refers to the Regulations the conditions needed to issue the free sale certificate for medical devices and supplies.
- Article 13The article allows the Authority to permit medical devices and supplies for personal use to enter with a medical report and in limited quantities, with no commercial purpose.
- Article 14The article requires anyone who dispensed or sold an adulterated, unregistered or unauthorized medical device to notify the Authority as soon as he learns of it and to refund the buyer's price.
- Article 15The article requires a manufacturer residing outside the Kingdom that wants to circulate its products there to appoint an authorized representative, subject to the Commercial Agencies Law.
- Article 16The article requires the manufacturer to provide after-sales services for its medical devices and supplies in accordance with the Law and the Regulations.
- Article 17The article requires establishments to comply with the identifying information that must appear on medical devices and supplies, and refers its determination to the Regulations.
- Article 18The article requires a health care provider not to deal with any establishment in the Law's activities unless it is registered and licensed in the same field of dealing.
- Article 19The article prohibits reprocessing medical devices or supplies intended for single use.
- Article 20The article bars destroying, reprocessing, refurbishing, selling, lending or donating used medical devices and supplies except under the Regulations' conditions.
- Article 21The article requires the manufacturer to classify medical devices and supplies in accordance with the classification system approved by the Authority.
- Article 22The article requires establishments that want to circulate medical devices and supplies in the Kingdom to apply a quality management system.
- Article 23The article bars dispensing medical devices and supplies classified as high-risk for use outside a health care establishment without a medical prescription, and the Authority issues the list of them.
- Article 24The article bars advertising, announcing and promoting medical devices and supplies except after the Authority's approval and under the Regulations' conditions.
- Article 25The article bars holding awareness campaigns, charitable campaigns or the like relating to medical devices and supplies except after the Authority's approval and under the Regulations' conditions.
- Article 26The article gives the Authority power to monitor health care providers' compliance with applying the technical regulations inside their facilities to ensure devices' safety, security and adequacy.
- Article 27The article requires the establishment and the authorized representative to provide the Authority with every document or piece of information it requests to carry out its jurisdiction under the Law and the Regulations.
- Article 28The article requires the manufacturer, the authorized representative and the health care provider to report incidents involving their medical devices and supplies to the National Center for Device Reports.
- Article 29The article tasks the National Center for Device Reports with issuing the safety alert to warn users and health care providers of the risks of using medical devices and supplies.
- Article 30The article requires the manufacturer and the authorized representative to notify the Center of external safety alerts, risks affecting safety, and completion of the corrective action.
- Article 31The article requires the establishment and the health care provider, when a safety alert is issued, to stop circulating the devices and supplies until the Center notifies them that the corrective action is complete.
- Article 32The article requires the establishment and the authorized representative to respond to the Authority's request to trace medical devices and supplies, and refers the procedures to the Regulations.
- Article 33The article gives the Authority power to inspect establishments and devices through inspectors who are judicial police officers, who may seize violating items, hold them, take samples and recommend destruction.
- Article 34The article requires everyone subject to the Law to keep confidential any information he may obtain by virtue of his duties.
- Article 35The article requires the inspector to show his official card during inspection and seizure, and requires the establishment to enable him to do his work and not obstruct him.
- Article 36The article allows the President, by decision, to grant the Authority's inspectors financial rewards for the work they perform.
- Article 37The article allows the President, by decision, to grant a person other than an inspector who helps uncover a violation a reward of no more than 25% of the fine due.
- Article 38The article tasks the Authority with setting the rules for granting inspectors' rewards and reporters' rewards, referred to in Articles 36 and 37, in agreement with the Ministry of Finance.
- Article 39The article allows the Authority to take the necessary precautionary measures where it believes there is harm, a misleading claim, or an effect on the safety, security and adequacy of devices.
- Article 40The article bars circulating medical devices and supplies if the Authority decides to withdraw them from the market or ban their circulation.
- Article 41The article lists the acts that are violations of the Medical Devices Law, such as adulteration, selling adulterated items, bringing in unregistered ones, false promotion and breaching transport and storage conditions.
- Article 42The article sets the penalties for violations of the Law: a fine of up to five million riyals, closure, suspension and cancellation, and up to ten years in prison or a fine of up to ten million for adulteration offenses.
- Article 43The article gives the Authority power to impose the penalties in paragraph 1 of Article 42 under a violations table issued by the Board that takes account of seriousness and circumstances, with precautionary measures permitted.
- Article 44The article creates a committee to hear grievances against penalty decisions under paragraph 1 of Article 42, and its decisions may be challenged before the Administrative Court.
- Article 45The article refers the violations covered by paragraph 2 of Article 42 to the Public Prosecution to investigate and refer to the competent court under the legal procedures.
- Article 46The article allows a judgment or penalty decision to include publishing its operative part, at the violator's expense, in a local newspaper or another suitable medium, after it becomes final.
- Article 47The article recognizes the right of anyone harmed by a violation of the Law to claim compensation before the competent court for the damage the violation caused.
- Article 48The article requires the Board to issue the Implementing Regulations within 180 days of the Law's publication in the Official Gazette, to take effect from the date the Law takes effect.
- Article 49The article sets the start of effect of the Medical Devices and Supplies Law at 180 days after its publication in the Official Gazette.