SFDA 医疗器械注册 （MDMA）

Navigating the SFDA medical device registration in Saudi Arabia, particularly the Medical Device Marketing Authorization (MDMA) process, is essential for manufacturers seeking entry into the rapidly expanding Saudi market.

The MDMA requirements have evolved to accommodate the advancement of international standards, such as the transition from the EU Medical Device Directives (MDD) to the Medical Device Regulations (MDR). The continuous development of medical device regulations in Saudi Arabia has increased the complexity of this process.

For example, even low-risk medical devices (supplies and consumables) became in need of an authorised representative (AR) and an MDMA approval.

We at PharmaKnowl offer expert support for the registration process. Whether you’re introducing new devices or modifying existing products, our team provides the strategic insight and technical expertise necessary to achieve a timely and successful market entry in Saudi Arabia.

This article clarifies the SFDA medical device registration requirements and defines the classification differences.

有关其他类型的商品注册，请参阅 SFDA 注册 站。

Registration Application Types

The SFDA regulates medical device products in Saudi Arabia to ensure their safety, efficacy, and quality. The manufacturers must acquire MDMA approval before marketing their products. Post-approval, they are responsible for safety reporting and other life cycle management operations, such as updates, renewals, and Unique Device Identification (UDI) submission.

以下是医疗器械注册程序的摘要：

MDNR（低风险） – 已取消

Companies used to register Non-sterile, non-measuring, Low-Risk Medical Devices through the Medical Device National Registry (MDNR), also known as “Medical Devices Listing,” which is exempt from MDMA and AR. However, in September 2022, the SFDA cancelled the MDNR procedure. Therefore, all devices must have a technical file for MDMA with an appointed AR in Saudi Arabia.

MDMA 1 （GHTF） – 已取消

在此申请途径中， SFDA 考虑了欧盟、美国、加拿大、澳大利亚和日本等 GHTF 成员国的批准。这是一条无需深入技术咨询即可轻松遵循的路线。然而，到 2021 年底， SFDA 已经取消了这条 GHTF 路线。

If you initially registered your product through MDMA 1, you can still use the same route to file renewals, minor updates, or variations. But the SFDA will still request the full technical file during the process.

MDMA 2 （反式脂肪）

From January 2022, all medical devices and in vitro diagnostics (IVDs) must receive an SFDA authorisation through the Technical File Application (TFA) registration route (MDMA2). This route resulted from the authority’s continuous updates to its regulations, influenced by the EU MDR and IVDR. It requires presenting the technical documentation in a clear, searchable, and organised manner.

因此，注册要求变得更加严格。必须满足许多条件，并且必须提供研究，例如临床评估报告 （CER）、生物相容性测试报告，以及需要在沙特阿拉伯进行上市后临床随访 （PMCF） 研究。

Although the TFA requirements are similar to those of the EU (CE mark), the SFDA does not require a CE certificate. However, if the product file doesn’t carry a CE mark, it will undergo a rigorous assessment.

注册要求

下面总结了这些要求，这些要求因商品类型和分类而异。以下是注册文件的高级部分：

• Administrative & Product Identification
  • Table of contents
  • 设备描述
  • 预期用途/目的
  • Device Classification
  • Model, Sizes, Accessories, and Variants
  • Device Label and Packaging Information
  • Instructions for use (IFU)
  • 设计信息
  • 制造信息
  • Device History (Approvals from Reference Countries)
• Safety, Risk & Performance Documentation
  • Essential Principles (EP List) of Safety & Performance (Required checklist)
  • 收益-风险分析
  • 风险管理文件（计划和报告）
  • Preclinical testing data
  • Biocompatibility Test Reports.
  • Electrical Safety, EMC, Software validation (as applicable)
  • Sterilisation and Shelf-Life Validation (if sterile)
• Clinical Evaluation & Surveillance
  • 临床调查计划和报告
  • 临床评估报告 （CER）
  • 上市后临床随访 （PMCF）
  • 市场后监督（PMS），计划和报告
  • 医疗器械定期安全更新报告 （PSUR）。

Download: Checklist of SFDA Medical Device Required Files for MDMA application

注册流程

分类

Applicants must classify their products according to the SFDA medical device classification rules within the MDMA application. These rules correspond to the EU regulation (CE certificate) since they are the unofficial SFDA reference regulations, but do not necessarily match them.

医疗设备

SFDA medical device classification is either Class A, B, C, or D, based on the risk class. The class is necessary to determine the registration procedure and its requirements, as discussed in the table below:

分类依据如下：

• 预期用途。
• 风险级别（对患者、用户和其他人造成伤害的可能性和严重性）。
• Nature of the device on or within the human body (e.g. invasive)
• Use duration (transient, short-term, long-term)

Identical devices could be classified differently according to the targeted body part or clinical setting. Therefore, the intended use is crucial in determining the correct classification. The intended use reference is reflected in the following:

• 使用说明 （IFU）
• 标签
• 宣传材料
• 技术文件

In Vitro Diagnostics (IVDs)

For in vitro diagnostic medical devices, the SFDA employs a risk-based classification system that is broadly aligned with the International Medical Device Regulators Forum (IMDRF) principles and is similar in structure to the EU IVDR, although it is applied independently.

申请人负责通过以下方式确定 IVD 的类别：

• 应用 IVD 医疗器械的分类规则，以及
• 考虑到：
  • 有可能的使用
  • 风险水平

Bundling Multiple Devices

Grouping multiple devices in the same application is permissible; the applicant may bundle up to 50 items in one MDMA application. However, products must meet several conditions, such as having the same legal manufacturer, the same risk class, and the same intended use.

时间线

The assessment timelines vary according to several factors, including risk class, product complexity, the number of bundled products, and the completeness of the file. Unidentified gaps before the submission may delay the approval. The entire timeline for the registration project includes:

• Gap Analysis Time
  This part depends on the number and type of gaps, the speed of manufacturer feedback, and the regulatory staff’s experience.
• SFDA 评估时间
  有关官方审核时间表，请参阅我们的文章 SFDA 时间表。

费用

MDMA 申请费用根据医疗器械风险等级和申请中的商品数量而有所不同。有关更多信息，请参阅我们更新的 SFDA 费用 博文。

更新

MDMA’s default validity is three years. When the license is near expiration, manufacturers can submit an MDMA renewal application up to three months (90 days) before the expiration date. If registered in the obsolete MDMA1 (GHTF) application, the renewal process would be long and require extensive additional technical files and studies, just like a new registration. In contrast, MDMA2 renewal will be faster.

更新

要更改已注册的医疗器械，制造商必须提交 MDMA 更新 申请。

MDMA 证书

SFDA 将颁发阿拉伯语和英语的 MDMA 证书，其中包含以下内容：

• The manufacturer’s information (License Holder)
• Medical Device Name and Medical Device Group Information.
• 有效期
• 证书编号

产品分类

以下是沙特阿拉伯的医疗器械类型和类别示例：

• 诊断设备：
  • 成像设备：X 光机、CT 扫描仪。
  • 监测设备：心电图机和血压监测仪。
  • 体外诊断设备：妊娠试验、血糖仪。
• 治疗设备：
  • 呼吸设备：呼吸机、雾化器。
  • 输液设备：胰岛素泵和静脉注射治疗设备。
  • 康复设备：轮椅、假肢。
• 植入式设备：
  • 心血管设备：起搏器、支架。
  • 骨科植入物：髋关节置换术、脊髓杆、关节置换术。
• 手术器械：
  • 切割工具： 手术刀、手术剪刀、镊子。
  • 吻合器和缝合线：手术吻合器、可吸收缝合线。
• 牙科设备：
  • 修复材料： 牙冠、填充物。
  • 正畸矫治器：牙套、保持器。
  • 其他：牙钻
• 眼科设备：
  • 矫正镜片： 隐形眼镜、眼镜。
  • 手术设备：LASIK 机器、人工晶状体。
• 医疗软件 （SaMD）：
  • 诊断软件：用于图像分析的 AI。
  • 治疗计划软件：放射治疗计划工具。
• 实验室设备：
  • Analysers: Blood gas analysers and haematology analysers.
  • Sterilisation equipment: Autoclaves, UV sterilisers.
• 医用气体
• 家庭医疗保健设备：
  • 监测设备：血糖监测仪和数字温度计。
  • 助行器：助行器、电动滑板车。
• 治疗设备（例如透析机）

医疗器械进口许可证 （MDIL）

Importing medical devices requires a valid MDMA. However, the SFDA may exempt some medical devices from registration and only require them to issue a medical device importing license (MDIL). For example:

• Demonstration or training purposes, medical devices.
• Chemicals (finished products), whether classified as medical devices or used in conjunction with medical devices (e.g., gases used to calibrate medical devices, as well as chemicals used to ensure the sterilisation operation of medical devices, the manufacturing of prostheses, and the preservation of tissues or cells). Excluding the following products:
  • 放射性物质
  • 医用体外诊断
  • 非医疗 IVD
  • 化学前体。
• 用于医疗保健提供者或教育设施的蒸馏设备。
• 研究和教育用途产品。
• 用于本地制造的半成品医疗器械/用品（以及原材料和非原材料化学品）（制造包括翻新、组装、包装和贴标）。

Whether your company is new to or already active in the Saudi market, PharmaKnowl will help you comply with the SFDA and facilitate your business by providing compliance, insights, and supply management to your distributors without shipment commission.

PharmaKnowl is an SFDA-licensed service provider in Saudi Arabia representing well-known international companies. Contact us to schedule an exploratory meeting or request more information.

Frequently Asked Questions