In the quickly changing field of medical technology, new product market access depends heavily on regulatory compliance. The Saudi Food and Drug Authority (SFDA) in the Kingdom of Saudi Arabia has established a robust regulatory framework to guarantee the security and effectiveness of medical devices. We will examine the latest developments and their implications for manufacturers looking to launch medical devices in the Saudi market as we delve into the nuances of this regulatory landscape in this article.
Understanding the Role of SFDA
The Saudi Food and Drug Authority (SFDA) oversees the regulatory framework for medical devices in Saudi Arabia. A thorough regulatory framework covering a medical device’s entire life cycle, from conception and design to post-marketing surveillance and monitoring, has been constructed by the SFDA. This system guarantees the effectiveness and safety of medical supplies and devices. The most recent changes brought forward by the SFDA can be navigated in the last two years:
The Year 2021
The year 2021 saw the implementation of the new Medical Devices and Supplies Regulation. This new regulation replaced The Medical Devices Interim Regulation. However, this regulation still contains most of the requirements from the interim regulation. All medical devices must receive market authorization, except those classified as safe and not meant for commercial purposes. SFDA also has the power to exempt innovative medical devices from some of its requirements and steps needed to receive market authorization.
The Year 2022
Until the SFDA extended the acceptance of Medical Device Marketing Authorization (MDMA) applications until January 1, 2022, SFDA also released guidelines for evaluating and approving AI and big-data-based medical devices.
The Version 5.0 of Classification Guidance
SFDA also published version 5.0 of the Saudi FDA Products Classification Guidance. This version discusses the following:
- Classification of borderline products and
- The e-Product Classification System (PCS) is used to submit product classification applications online.
Navigating the Changes in Version 5.0 of Classification Guidance
The following changes have been made in the Version 5.0 of Classification Guidance:
Several new examples of medical devices have been added, such as gases to operate medical devices and certain hygiene products (e.g., adult diapers).
The section on significant spare parts as being devices in their own right has been removed.
A clarification that the medical devices using cells and tissues of human (or animal) origin (or their derivatives), whether viable or non-viable, should have an MDMA obtained from the SFDA has also been added. Without obtaining MDMA from SFDA, the device won’t be allowed to be marketed in Saudi Arabia.
The Medical Device Approval Process for SFDA
The SFDA medical device approval comprises the following five steps:
- Step 1: The manufacturer must determine their device’s classification per SFDA’s rules.
- Step 2: KSA Authorized Representative (AR) must be appointed in this step. The AR manages device registration and interacts with SFDA on the manufacturer’s behalf. Also, KSA SR must present the authenticated AAR contract to the SFDA for review. The KSA SR will also obtain a license from SFDA to represent the manufacturer in KSA.
- Step 3: The manufacturer will prepare the Technical File and application form to be submitted to SFDA.
- Step 4: The manufacturer will pay the application fee for SFDA to review it. Here, SFDA can also ask for any additional information.
- Step 5: Once SFDA approves, the manufacturer will get a Medical Device Marketing Authorization (MDMA) certificate for their device.
Necessary Documentation for SFDA Device Approval Process
The following necessary documentation is required by SFDA while applying for the device’s approval. The submitted information must be in English and should contain the following:
- Trade name in English (and in Arabic if it is intended for lay use).
- Model name, number, and catalog
- Device’s description
- Intended purpose
- Classification, and
- Evidence of approval in other countries (if available).
- Labels and packaging
- Power supply label (where applicable)
- Instructions for Use (IFU) or justification letter
- Information regarding storage, maintenance, transportation, installation, and disposal.
- Proposed advertising material
Labeling information regarding barcodes is:
- They are only required for lay-device users, and
- The Unique Device Identification (UDI) section should be consulted for information regarding SFDA’s implementation of UDI requirements regarding all devices.
Also, it is important to mention that SFDA requests explanations regarding the version digits for software. For example, it may ask for an explanation regarding digits representing major and minor changes.
Design and Manufacturing Information
This will contain:
- Bill of materials
- Description of assembly and function of the device
- Technical specifications and
- Flow of the manufacturing process
Benefit-Risk Analysis and Risk Management
- Risk analysis
- Risk management plan, and
- Risk management report
Product Verification and Validation
This will include information on pre-clinical data and clinical data. Last, a Declaration of Conformity must also be submitted with the application. Manufacturers can further consult Annex 14 of MDS-REQ 1 for the template of the Declaration of Conformity.
TSQE Experts on KSA Regulations
In this blog, we presented the significant aspects of the regulatory environment concerning medical devices and their registration in the KSA. If you want to know more about the registration process or want to get your device registered in KSA, then contact us today!