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Our Regulatory Approach
A regulatory-first medical trade model built on compliance, risk mitigation, and institutional trust
Built on Regulatory Excellence
Our operations are structured around comprehensive regulatory frameworks that govern medical device trade across Turkish and European markets
Turkish Medical Device Regulations
Full compliance with Turkish Ministry of Health requirements and medical device authorization procedures
EU Medical Device Regulation (MDR)
Adherence to EU MDR 2017/745 for cross-border medical device trade within European markets
Quality Management Systems
ISO 13485:2016 certified processes ensuring consistent quality in medical device handling
Data Protection & Privacy
Strict compliance with KVKK and GDPR for all personal and institutional data processing
Regulated Supply Chain — Operating under Turkish and EU Medical Device Regulations
Comprehensive Risk Management
Our four-phase risk mitigation strategy protects partners from regulatory non-compliance and ensures seamless medical device trade
Pre-Trade Assessment
Supplier regulatory status verification
Product certification validation (CE, FDA, ISO)
Documentation completeness review
Market authorization confirmation
Due Diligence
Technical file assessment
Quality management system audit
Supply chain transparency check
Regulatory history evaluation
Transaction Monitoring
Real-time compliance tracking
Documentation accuracy verification
Cross-border regulation adherence
Customs and import compliance
Post-Trade Compliance
Post-market surveillance support
Adverse event reporting protocols
Regulatory update notifications
Continuous compliance monitoring
Institutional B2B Only — Our risk mitigation protocols are designed exclusively for institutional partners in regulated medical markets
Explore Partnership BenefitsRegulatory-First Medical Trade Model
Unlike traditional medical distributors, MGS International operates with a regulatory-first approach. Compliance is not an afterthought—it's the foundation of every partnership and transaction.
This model ensures that our partners benefit from reduced regulatory risk, faster market access, and long-term operational stability in highly regulated medical markets.
"Our regulatory-first model has enabled us to maintain a 100% compliance record across all markets we operate in, providing our partners with unmatched peace of mind."
Compliance-First Approach
All trade operations begin with documentation verification and regulatory alignment assessment before proceeding with supply coordination.
Documentation Accuracy
Comprehensive support for certificates, declarations, technical files, and shipment documentation provided by manufacturers.
Cross-Border Coordination
Expertise in navigating international trade requirements across Europe, Middle East, and North Africa regulated markets.
Manufacturer Partnerships
Long-term relationships with certified manufacturers ensuring consistent quality and regulatory compliance support.
Institutional Focus
Dedicated to serving hospitals, clinics, and healthcare institutions with professional procurement and supply solutions.
Continuous Monitoring
Regular updates on regulatory changes and proactive adaptation to evolving compliance requirements across markets.
Partner with Regulatory Confidence
Our regulatory-first approach provides institutional partners with the compliance infrastructure needed to operate confidently in complex medical device markets.