The new system, GHAD, provides a single platform for submitting Medical Device Marketing Authorization (MDMA), Medical Device National Registry (MDNR), Saudi Authorized Representative and related applications to SFDA.
Saudi New medical device regulations & MDMA fee increases (update)
- Saudi Arabia moved from Global Harmonization Task Force (GHTF) jurisdictions in March 2020, as a basis of regulations, to medical devices Technical File Assessment (TFA). Receiving new marketing authorization requests via the GHTF route will be extended until (01/07/2021), and optionally via the Saudi Route (TFA), the Saudi Food & Drug Authority (SFDA) reserve the right to request the technical file or part of it whenever needed.
- In January 2020, the SFDA issued guidance on requirements of medical devices quality management system for distributors, importers and authorised representatives. Organisations manufacturing and servicing medical devices (manufacturers, authorised representatives, distributors and importers) now have to be certified to ISO 13485:2016, the international quality management system (QMS) standard for medical devices.
- The Saudi Food & Drug Authority (SFDA), the medical device market regulator, plans to raise registration fees as well as implement a new device regulatory system in the coming months.
- SFDA announced that both guidance are dedicated to innovative medical devices and new applicable standards and have been developed during the process of making general improvements to the medical device regulatory framework.
In December 2019, Saudi Arabia launched a new Unified Electronic System “GHAD” replacing existing medical devices systems for listing, registration and establishment licensing (MDMA, MDNR and SFDA). As per July 2021, local and foreign Medical Devices manufacturers are request to register or renew their licences under the new system GHAD. Accordingly, Saudi medical device market registrants and in-country representatives face a July 1, 2021 deadline to open GHAD accounts and transfer both existing and in-process applications over to the new system. Following that deadline, any applications not yet migrated to GHAD will be cancelled. The new SFDA requirements include a new risk classification system for devices, which may result in manufacturers no longer being able to leverage reference markets such as the European Union or US to obtain registration in Saudi Arabia. Besides establishing a new regulatory system for medical devices, SFDA increased the fee for Medical Device Marketing Authorization (MDMA).
If implemented as planned, the new fees would mean an increase of between roughly USD $3’000 to $8’000 per application. The new fees will be based on the number of devices and/or accessories included in an MDMA application, whereas currently fees are assessed according to device risk class as well as leveraged reference market.
To assist medical device manufacturers failing to comply with new requirements in the time, SFDA has postponed the reinforcement of the new system from December 26, 2019 to January 1, 2021 and then to July 1, 2021. The interested companies have until March 31, 2020 to register or renew under the current system.
60-calendar-day deadline
SFDA has set a 60-calendar-day deadline for MDMA applicants to respond to inquiries from the regulator or from Conformity Assessment Bodies. Applicants needing additional time to address issues should provide justifications to SFDA. Otherwise, failure to meet the 60-day deadline will result in SFDA deleting the MDMA application in question. Although some manufacturers will be challenged to meet these requirements, the new deadline may reduce overall SFDA review and approval timeframes for MDMA applicants. It is noteworthy that SFDA is willing to enhance the transparency of the working mechanism for the deletion of applications due to repeated observations or delayed response.
SFDA Technical Files Assessment
As per the new regulation, more “technical files” will be required from the manufacturers to provide evidence of compliance to a certain route. Thus, the manufacturer has to provide the following:
- The Technical File document in which the intended use and clinical benefits are stated to each device.
- Post-Market Surveillance (PMS) plan and report for each device.
- Risk management report and plan.
- Classification and compliance check list.
- Clinical evaluation report.
- Post marketing clinical follow up.
- The new regulations (MDS-G5)
The published (MDS-G5)
Guidance on Requirements for Medical Device Listing and Marketing Authorization Requirements describes the conditions to be assessed by the authority when deciding on the possibility of marketing authorization required by the medical device manufacturer or its authorized representative to be allowed to place the device on the Saudi market. The guidance also provides information regarding general requirements and essential principles to be applied at each step of the medical device’s lifecycle.
New product approval validity and fees
The expiry date of the product approvals used to depend on the expiry of the manufacturer certificates and maximum of 3 years. However, the new system will issue an approval for 3 years consistently, and fees for review will depend on the number of items in the application.
New guidance for innovative devices and standards
The SFDA also released two new guidance documents. Guidance on Innovative Medical Devices that specifies the designation criteria for innovative medical devices and outlines a priority review procedure for them, with the stated intention of maintaining both safety evaluation and rapid market access. The second document describes over 350 standards, which are recognised by the SFDA that can be used in support of premarket submissions.
