Medical Device Registration in Saudi Arabia: A Step-by-Step Guide

The Kingdom of Saudi Arabia represents one of the most significant medical device markets in the Middle East. With the Saudi Food & Drug Authority (SFDA) implementing robust regulatory requirements, manufacturers must navigate a structured registration process to access this market.

Regulatory Framework

Medical devices in KSA are regulated under the Medical Devices Law and its Implementing Regulation, administered by the SFDA. Devices are classified into four risk categories (Class A, B, C, and D), roughly aligned with the international classification scheme.

Key Requirements

1. Medical Device Marketing Authorization (MDMA)

Manufacturers must obtain MDMA before placing a device on the Saudi market. The application is submitted through the SFDA's electronic system, GHAD, by the manufacturer or its authorized representative.

2. Authorized Representative

Foreign manufacturers must appoint a Saudi Authorized Representative (AR) who is licensed by the SFDA. The AR is responsible for communications with the SFDA, post-market surveillance, and incident reporting.

3. Technical Documentation

The MDMA submission requires comprehensive technical documentation, including:

Device description and specifications

Classification rationale

Quality management system certificate (ISO 13485)

Declaration of Conformity (DoC)

Risk management file

Clinical evaluation

Labeling and IFU (in Arabic or English with Arabic where required)

UDI information

4. QMS Requirements

Manufacturers must maintain a quality management system conforming to ISO 13485. SFDA inspections may be conducted to verify compliance.

5. Post-Market Surveillance

Once approved, manufacturers must implement post-market surveillance, including vigilance reporting and periodic safety update reports.

How We Help

Veritas Quality Solutions has supported numerous manufacturers in obtaining MDMA approvals in KSA. Our services include:

Classification and regulatory strategy

Authorized Representative services

Technical documentation preparation and review

MDMA application management

SFDA inspection readiness

Post-market surveillance support