SFDA Regulatory Strategy & Product Classification

Classification Drives the Saudi Evidence and Authorization Route. Saudi Arabia uses a risk-based classification framework for medical devices. Devices other than IVDs are classified as Class A, B, C or D, with additional distinctions for certain Class A sterile, measuring and reusable surgical instruments. IVDs are also classified from Class A through Class D based on individual and public-health risk.

Define Your SFDA Regulatory Pathway

When This Support Is Needed

Introducing a new medical device or IVD into the Kingdom of Saudi Arabia

Intended clinical purpose or indications differ from existing US FDA or CE mark claims

Uncertainty regarding whether a software algorithm constitutes a regulated SaMD or accessory

Structuring a device family or system grouping for MDMA submission in the GHAD portal

Evaluating whether an engineering change or software update alters the established SFDA risk class

What We Challenge Before Submission

Does the intended medical purpose cleanly defend the assigned SFDA risk class?

Are sterile, measuring, or reusable surgical attributes properly identified for Class A devices?

Will an active diagnostic or therapeutic function trigger higher-risk Class C/D rules?

Does the overseas technical file directly support the Saudi configuration and claims?

Have all system components, accessories, and consumables been appropriately classified?

Our Support Scope

Product qualification and Saudi regulatory-status assessment

Intended purpose, clinical indication, and marketing claims review

Class A, B, C, and D classification assessment for non-IVD medical devices

IVD Class A, B, C, and D risk-based classification assessment

Accessory, system, and medical device combination considerations

Software as a Medical Device (SaMD) and digital health classification strategy

Classification-rule justification documentation under SFDA guidelines

Regulatory evidence roadmap connecting classification to MDMA technical file depth

Assessment of whether a change in intended purpose or technology affects classification

Strategic Approach:

We do not stop at assigning a class. We trace the classification into the technical documentation, level of evidence, QMS expectations, local regulatory structure and post-market controls that must follow.

Establish Your SFDA Risk Classification and Authorization Pathway

Our Saudi regulatory consultants classify your medical devices, IVDs and SaMD under SFDA rules to build a compliant MDMA strategy.

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