SFDA Medical Device Registration for Algerian Manufacturers

Operon Strategist provides expert SFDA medical device registration consulting for Algerian manufacturers aiming to enter the Saudi Arabian market. Our services cover the complete Medical Device Marketing Authorization (MDMA) process, including device classification, preparation of SFDA-compliant technical dossiers, ISO 13485 QMS compliance, and appointment of a Saudi-based authorized representative. We assist with online MDMA registration, clinical data review, quality system audits, and post-market surveillance (PMS) obligations, ensuring a smooth and timely approval process. With in-depth knowledge of Saudi regulations, including the latest updates from the Saudi FDA, we help Algerian medical device companies achieve regulatory compliance, gain market access, and maintain ongoing vigilance reporting with confidence.

Why Partner with SFDA Medical Device Registration Consultants?

SFDA registration requires in-depth knowledge of regulations, procedures, and documentation. Our consultants provide:

Expert knowledge of Saudi medical device regulations and recent updates.
Compliance support for documentation, QMS, and ISO 13485 certification.
End-to-end guidance through Medical Device Marketing Authorization (MDMA) approval.
Efficient process handling, reducing regulatory complexities.

With professional guidance, Algerian manufacturers can enter the Saudi Arabian healthcare market confidently and compliantly.

SFDA Medical Device Registration – An Overview

The SFDA acts as the national regulatory authority for medical devices and IVDs. All devices require Medical Device Marketing Authorization (MDMA) approval before being placed in the Saudi market.

Between 2019 and 2022, Saudi Arabia updated its regulations, impacting device classification and MDMA requirements. As a result, previously approved devices must now comply with the revised framework.

Operon Strategist continuously monitors these regulatory updates to provide Algerian manufacturers with the most accurate compliance strategies.

Medical Device Regulations in Saudi Arabia

Before entering the Saudi market, Algerian manufacturers must ensure compliance with the following:
Regulatory Authority: Saudi Food & Drug Authority (SFDA)
Regulation: Royal Decree No. (M/54)
Regulatory Pathway: MDMA Approval
Authorized Representative: Saudi-based Representative is mandatory
QMS Requirement: ISO 13485:2016 certification

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Medical Device Marketing Authorization (MDMA)

The MDMA system manages device approvals. Most device classes require MDMA before entering the market.

Timeline: Average of 35 days for approval.
Validity: Registration remains valid for 3 years (or for the original specified duration).

SFDA Device Classification Rules

General Medical Devices

The SFDA follows the MDS-G5 guidelines, similar to the European MDR framework. Devices are classified into Class A, B, C, or D, based on risk.

SFDA Class	Risk Level	MDR Equivalent	Example
A	Low	Class I	Low-risk general devices
A – S	Low-medium	Class Is	Sterile devices
A – M	Low-medium	Class Im	Measuring devices
A – R	Low-medium	Class Ir	Reusable surgical instruments
B	Low-medium	Class IIa	Active devices
C	Medium-high	Class IIb	More invasive devices
D	High	Class III	High-risk, life-supporting devices

In Vitro Diagnostics (IVDs)

The SFDA also aligns with the European IVDR.

SFDA Class	Risk Definition	Example
A	Low risk	Routine IVDs
B	Moderate risk	Infectious disease tests
C	High individual risk	Blood screening devices
D	High public health risk	HIV/HBV/HCV tests

SFDA Medical Device Registration Process for Algerian Manufacturers

Preparation & Documentation
- Identify device classification per SFDA rules
- Prepare a complete technical file with design, labeling, and clinical data
- Ensure ISO 13485 QMS compliance
Appoint an Authorized Representative
- Foreign manufacturers must assign a local Saudi representative
Online Application
- Submit application via the SFDA MDMA portal
Review & Evaluation
- SFDA reviews technical, clinical, and quality documentation
Clinical Data Review (if required)
- For new or high-risk devices, additional evidence may be requested
Quality System Audit (if required)
- SFDA may conduct a QMS audit of your manufacturing facility
Approval & Registration
- Upon successful review, SFDA issues the registration certificate
Post-Market Surveillance (PMS)
- Ongoing obligations include vigilance reporting and adverse event tracking

Documentation Required for SFDA Registration

All documents must be submitted in English via the MDMA portal. Required documentation includes:

Manufacturer details and Saudi Authorized Representative information
Device description, intended use, labeling, and promotional materials
Proof of approval/market authorization in a GHTF country
Clinical data (if applicable) to prove safety and performance
Declaration of compliance with National Centre for Medical Devices Reporting (NCMDR) vigilance system

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How Operon Strategist Helps Algerian Manufacturers

Operon Strategist simplifies the complex SFDA registration journey for Algerian medical device manufacturers.

Our Key Services

Regulatory Pathway Guidance – Assistance with classification and strategy
MDMA Portal Support – Smooth application submission via SFDA system
Technical Dossier Preparation – Compiling SFDA-compliant documents
Authorized Representative Services – Helping appoint a Saudi-based agent
QMS & ISO 13485 Compliance – Implementation support for required standards
Post-Market Surveillance (PMS) – Guidance on vigilance systems and reporting

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