Inside NCMDR: Everything You Should Know About Medical Device Reporting

The National Center for Medical Device Reporting (NCMDR) is an entity body managing a database of information on safety and performance related aspects of medical devices and helps to resolve any problem raised. NCMDR is responsible for safeguarding patient’s health. To achieve this, Saudi FDA maintains an up-to-date database of medical device FSN (Failure Safety Notice) recalls and adverse event reports, encompassing products manufactured in or imported into the Kingdom of Saudi Arabia. The Saudi FDA also collaborates closely with hospitals and healthcare providers to ensure they take appropriate corrective actions.

Saudi FDA Medical Device Definition

It is defined as “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or – intended to affect the structure or any function of the body of man or other animals and does not achieve its primary intended purposes through chemical action” (CDR Kimberly Piermatteo, 2021)

The Role and Responsibilities of NCMDR

The National Center for Medical Devices Reporting (NCMDR) receives reports of suspected adverse events and confirmed product recalls related to medical devices from healthcare practitioners and Legal manufacturers within the Kingdom of Saudi Arabia. Saudi Food and Drug Authority (SAUDI FDA) personnel thoroughly investigate all submissions and, whenever possible, provide technical and clinical guidance to help all affected parties—not just the original reporter—avoid or resolve issues related to medical devices. NCMDR's overarching goal is to improve patient and caregiver safety through the distribution of accurate, actionable information.

Saudi FDA Introduces Saudi Vigilance System to Streamline NCMDR

The Saudi Food and Drug Authority (Saudi FDA) has launched the Unified Electronic System (GHAD) to streamline and replace the National Center for Medical Devices Reporting (NCMDR) for various services related to cosmetic and perfumery products. This new system is essential for manufacturers and exporters of these products to Saudi Arabia.

Effective from March 30, 2023, the Saudi Vigilance System will be Mandatory for the following services:

1. Notification of Cosmetic and Perfumery Products: Saudi Vigilance System will handle all notifications related to these products, replacing the role previously managed by NCMDR.
2. Notification of Manufacturing Sites: The registration and notification of manufacturing sites for cosmetic and perfumery products will now be processed through Saudi Vigilance System instead of NCMDR.
3. Warehouse Licensing: Licensing for warehouses storing cosmetic and perfumery products will transition from NCMDR to Saudi Vigilance System.

To facilitate this transition, Saudi FDA has instructed all users currently registered with NCMDR to create new accounts in the Saudi Vigilance system. This step will enable the automatic linking and migration of existing data from NCMDR to GHAD. Additionally, any ongoing applications in the NCMDR system must be completed before March 30, 2023, as no new applications will be accepted on NCMDR after this date. The NCMDR database will remain accessible until September 30, 2023.

Intertek is ready to assist businesses in navigating this significant regulatory change, ensuring compliance with the new Saudi FDA requirements and helping them understand and apply the latest market access regulations in Saudi Arabia.

Goal of NMCDR

The establishment of the National Center for Medical Devices Reporting (NCMDR) aims to:

• Improve the protection of the health and safety of patients, users, and others.
• Disseminate relevant device-related information which may reduce the likelihood of, or prevent the repetition of, adverse events, or alleviate the consequences of such repetitions.
• Encourage collaboration between manufacturers and healthcare providers to identify and investigate adverse events associated with medical devices and take appropriate action to execute a key aspect of Saudi FDA's post-market surveillance activities.
• Encourage the reporting of adverse events by medical device institutions and users, manufacturers, authorized representatives and organizations involved in supplying medical devices to the Saudi Arabia.

Adverse Events and Reporting

An adverse event refers to any occurrence that leads or could lead to unexpected safety issues affecting patients, users, or others. This includes problems like device design flaws, user errors, inadequate maintenance, or unsuitable storage conditions.

Reporting Criteria:

1. Occurrence of an Event: Includes device malfunctions, design deficiencies, labeling inaccuracies, public health concerns, and user errors.
2. Outcome of the Event: Includes incidents leading to death, serious injury, or potential for serious injury if repeated.
3. Device Association: Considers the healthcare professional's opinion, previous similar events, and other relevant information.

Recalls:

A recall addresses issues with medical devices that violate Saudi FDA regulations, due to defects or health risks.

Types of Actions in Recalls:

• Inspecting, repairing, or adjusting devices
• Re-labeling or scraping faulty devices
• Notifying users of potential issues

Recall Categories:

• Class I: High risk
• Class II: Medium risk
• Class III: Low risk

Responsibility for Recalls:

• Typically initiated voluntarily by manufacturers or other responsible parties.
• Saudi FDA can mandate a recall if necessary.

How to Report an Adverse Event

Who Can Report? Healthcare providers, manufacturers, authorized representatives, distributors, and the public can all submit reports about adverse events involving medical devices.