Introduction ISO 13485 Under SFDA
In Saudi Arabia, medical device manufacturers must comply with the regulations of the Saudi Food and Drug Authority (SFDA) to ensure the safety, quality, and effectiveness of their products. One of the most effective ways to meet these regulatory requirements is by implementing ISO 13485, the international quality management system standard for medical devices.
ISO 13485 provides a structured framework that supports manufacturers in fulfilling their legal responsibilities under SFDA regulations, from product design and development to post-market surveillance.
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Understanding Legal Manufacturer Responsibilities Under SFDA
A legal manufacturer is the entity responsible for the design, manufacturing, packaging, and labeling of a medical device before it is placed on the Saudi market. Under SFDA, a legal manufacturer is accountable for:
- Regulatory compliance: Ensuring the device meets SFDA registration and approval requirements.
- Product quality & safety: Maintaining systems to ensure device safety throughout its lifecycle.
- Risk management: Identifying, controlling, and monitoring risks associated with the device.
- Post-market surveillance: Monitoring product performance and reporting adverse events to SFDA.
- Traceability & documentation: Ensuring device traceability and keeping technical documentation up to date.
How ISO 13485 Supports SFDA Compliance
ISO 13485 aligns directly with SFDA’s expectations for medical device manufacturers. Here’s how:
ISO 13485 requires manufacturers to establish a robust QMS, which supports SFDA’s requirement for documented processes, controls, and accountability across operations.
- Risk Management Integration
Risk management is central to ISO 13485 and SFDA’s regulatory framework. By applying ISO 14971 within ISO 13485 QMS, manufacturers can demonstrate risk control throughout the device lifecycle.
- Documentation and Record-Keeping
ISO 13485 emphasizes proper documentation of design, development, manufacturing, and post-market activities. This aligns with SFDA’s requirement for complete technical documentation during device registration and audits.
- Supplier and Outsourcing Controls
SFDA holds legal manufacturers accountable for outsourced processes. ISO 13485 requires controls over suppliers and subcontractors, ensuring compliance even when third parties are involved.
- Corrective and Preventive Actions (CAPA)
ISO 13485 requires systematic CAPA processes, supporting SFDA’s demand for proactive quality management and continuous improvement.
- Post-Market Surveillance
SFDA mandates active monitoring of device performance. ISO 13485 supports this through feedback collection, vigilance reporting, and continual risk assessment.
Benefits of ISO 13485 Certification for Saudi Manufacturers
- Simplifies SFDA approval processes.
- Builds trust with regulators and customers.
- Reduces the risk of non-compliance penalties.
- Strengthens market access not only in Saudi Arabia but also globally.
Ensure SFDA compliance with expert ISO 13485 guidance
Role of Operon Strategist
At Operon Strategist, we assist medical device manufacturers in Saudi Arabia and globally with:
- Implementing ISO 13485-compliant QMS.
- Preparing technical documentation for SFDA submissions.
- Conducting internal audits and gap assessments.
- Providing training for compliance with ISO 13485 and SFDA guidelines.
- Supporting end-to-end regulatory consulting for medical device registration.
With our expertise, manufacturers can seamlessly align their ISO 13485 certification with SFDA requirements, ensuring smooth regulatory approvals and driving business growth.
