UAE PDPL
UAE federal law protecting personal data onshore
ISO 13485
International standard for medical devices quality management systems
Quick Verdict
UAE PDPL mandates privacy protections for personal data in onshore UAE, while ISO 13485 certifies quality systems for medical devices globally. Organizations adopt PDPL for legal compliance and trust; ISO 13485 for market access and regulatory alignment.
UAE PDPL
Federal Decree-Law No. 45/2021 Personal Data Protection
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls across device lifecycle stages
- Design development planning verification and validation
- Post-market surveillance complaint handling reporting
- Supplier evaluation monitoring and quality agreements
- Process validation for sterilization and production
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
UAE PDPL Details
What It Is
UAE PDPL (Federal Decree-Law No. 45 of 2021 Concerning the Protection of Personal Data) is a comprehensive federal regulation governing personal data processing onshore. Effective January 2022, it adopts a risk-based approach aligning with GDPR-like principles for fairness, transparency, and security.
Key Components
- Core principles: purpose limitation, minimization, accuracy, storage limitation, security.
- Obligations: mandatory Records of Processing Activities (RoPA), DPO for high-risk, DPIAs for new tech/large sensitive data volumes.
- Data subject rights: access, portability, erasure, objection to profiling.
- No certification; compliance demonstrated via records and audits.
Why Organizations Use It
Mandated for onshore entities processing UAE residents' data; extraterritorial reach. Mitigates fines up to AED 5M, builds trust, enables secure digital economy. Enhances cybersecurity, vendor management, cross-border flows.
Implementation Overview
Phased: gap analysis, data inventory, DPIAs, security controls, training. Applies to private sector; excludes free zones, government, sectoral data. No formal certification; ongoing Bureau oversight.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a certifiable framework for risk-based QMS tailored to medical device lifecycles, from design to post-market surveillance, emphasizing regulatory compliance and patient safety.
Key Components
- Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
- Over 20 documented procedures/records required, built on process approach and ISO 9001 compatibility.
- Core principles: risk management (ISO 14971), validation, traceability, CAPA.
- Third-party certification via accredited bodies with stage audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Reduces risks like recalls via supplier controls, post-market feedback.
- Builds stakeholder trust, operational efficiency, competitive edge.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Suits manufacturers/suppliers globally; 9–18 months typical.
- Involves eQMS, cross-functional teams, management reviews. (178 words)
Key Differences
| Aspect | UAE PDPL | ISO 13485 |
|---|---|---|
| Scope | Personal data processing, privacy, security | Medical device quality management lifecycle |
| Industry | All onshore private sectors, UAE residents | Medical devices, healthcare supply chain globally |
| Nature | Mandatory federal law, enforced by Data Office | Voluntary certification standard for regulation |
| Testing | DPIAs for high-risk, breach notifications | Internal audits, process validation, certification audits |
| Penalties | Administrative fines up to AED 5M | Loss of certification, no direct fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about UAE PDPL and ISO 13485
UAE PDPL FAQ
ISO 13485 FAQ
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