International Market Expansion for Medical Device Manufacturers
DEMEDs supports medical device manufacturers in expanding into emerging healthcare markets including Turkey and Central Asia.
From regulatory pathway assessment to product registration and distributor coordination, our experts help manufacturers navigate regional regulatory systems and establish compliant market access strategies for sustainable growth.
Our Expertise
- Regional Regulatory Strategy
- Guidance for manufacturers entering new markets including regulatory pathway identification, documentation preparation, and compliance with national regulatory frameworks.
- Product Registration & Market Authorization
- Preparation and submission of registration dossiers for medical devices according to national regulatory requirements and regional regulatory frameworks.
- Distributor & Partner Coordination
- Support in identifying and working with local distributors, ensuring regulatory responsibilities and market access procedures are properly managed.
- Regulatory Infrastructure
- Implementation of essential regulatory systems such as local authorized representation, product database registrations, and post-market compliance.
Our Services
- Market entry strategy and regulatory roadmap
- Product registration support in Turkey
- Device registration in the Ürün Takip Sistemi (UTS)
- Regulatory expansion into Kazakhstan, Uzbekistan, Kyrgyzstan, and neighboring markets
- Documentation localization and regulatory dossier preparation
- Distributor onboarding and regulatory coordination
- Import licensing and compliance guidance
- Multi-country regulatory strategy development