Turkey
Turkey represents a growing market for medical devices, with increasing demand for innovative healthcare technologies and strategic access to European and Middle Eastern markets.
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Regulatory Framework
The regulatory authority is the Turkish Medicines and Medical Devices Agency (TMMDA), responsible for the approval and surveillance of medical devices.
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in Turkish. |
| Local Representative | Required for foreign companies. |
| Certifications | Compliance with CE regulations and TMMDA requirements. |
Challenges and Operational Advice
- Alignment with EU regulations: Turkey follows European directives for medical devices.
- Variable process: Registration times can exceed 12 months for high-risk devices.
- Language barriers: Documents and labeling must be in Turkish.
Why Choose ISEMED
- Local Expertise
Comprehensive support with TMMDA registration. - Specialized Assistance
Management of timelines and documentation. - Network of Contacts
Collaboration with regulatory bodies to facilitate market access.
FAQ
- Is a local representative required? Yes.
- Documentation language? Turkish.
- License duration? Expires when the CE certificate expires.