Combination products are physically, chemically, or otherwise combined or mixed to form a single entity, such as drug/device, biologic/device, drug/biologic, or drug/device/biologic. In Saudi Arabia, such combined components may require one or more marketing approvals from the Saudi Food and Drug Authority (SFDA). Therefore, understanding how the authority would consider your product is crucial to determining the appropriate product registration pathway.

This article elaborates on the SFDA’s current guidance and outlines the process for determining the pathway.

What are Combination Products?

These products consist of two or more items that are subject to more than one different SFDA regulation. The SFDA defines the following major types:

Integrated Combination Products: A product that consists of two or more regulated components combined/integrated into a single product, such as a prefilled insulin pen or a drug-eluting stent.
Non-Integrated Combination Products: A product that consists of two or more separate items that are co-packaged or cross-labeled to achieve the intended purpose of use, such as a vaccine vial with a delivery device or a light-activated drug with a light-emitting device.

Criteria for classification of combination products

The SFDA considers several factors to determine the appropriate regulatory pathway. These include:

Statutory Definitions: How each product and its components are defined under Saudi regulations.
Proposed Indication/Claim: The intended use as stated by the manufacturer.
Primary Mode of Action (PMOA): Is the claimed effect/purpose mainly pharmacological, immunological, or metabolic?
- If the main action is pharmacological, it’s regulated as a drug.
- If not, and the mechanism of action is mechanical, it’s a device (even if it is supported by drugs or biologics).
Equal degrees of action: Products with separate modes of action, with neither inferior to the other; the case will be assigned to the sector that receives queries regarding the products’ safety and efficacy.
Consideration of Expertise: If such a sector does not exist, it will be assigned to the sector with the most relevant technical expertise.
The classification of the product in SRA (Stringent Regulatory Authority)

Regulatory Process & Appeal

If the classification is unclear, company applicants can submit a classification request to the ePCS (electronic Product Classification System) at the GHAD system.
The Products Classification Department reviews the product to determine whether it is a combination product and assigns the request to the relevant sectors.
Complex cases are escalated to the Joint Advisory Committee.
If the applicant disagrees with the classification, they may file an appeal within sixty (60) days.

Data Requirements for Registration/Marketing Authorization

Phases	Period	Submission requirement		Requirement status
		Drug	Medical device
Phase I	2026-2027	Submit the application in accordance with the requirements of the leading sector (drug or medical device).		Not mandatory
Phase II	2027-2030	1) Complete eCTD 2) Supporting medical device documentation	1) Technical documentation (MDS-REQ1) 2)Supporting drug dossier	Voluntary
Phase III	2030			Mandatory

Timelines

The evaluation timelines are based on the leading sector. For example, suppose a drug and a medical device are combined, and the SFDA assigns the review to the drug sector. In that case, the drug application timeline is followed.

The timeline for: