Our Legal Services for the Medical Devices Sector
Our experienced legal team provides comprehensive support tailored to the specific needs of medical devices businesses operating in Turkey:
- Product registration
- Clinical investigation authorization
- Quality management systems
- Distribution agreements
- Adverse event reporting
- Regulatory submissions
- Litigation and filing of lawsuits before Turkish courts
- Case follow-up and litigation management
- Debt collection and enforcement proceedings (icra takibi)
Key Legal & Regulatory Issues in Turkey
Companies in the medical devices sector should be aware of the following regulatory and legal considerations when operating in Turkey:
- Device classification
- CE marking for medical devices
- Post-market surveillance
- Clinical data requirements
- Labeling compliance
- Authorized representative
Which Legal Route Applies?
Determine the product's intended medical purpose and classification before selecting conformity and market-access steps. Device obligations differ from medicinal marketing authorisation and ordinary consumer-product rules.
Evidence to Prepare Before the Next Step
Prepare technical and conformity evidence, manufacturer and importer details, labels, traceability and post-market arrangements. Assess the applicable TITCK and ÜTS route and any patient-data processing separately.
Sources & Authorities
Relevant statutory framework and official guidance. Applicable requirements depend on the activity, documents and current rules.
Why Work With Turkish Trade Lawyers
Industry Understanding
We understand the commercial realities and regulatory environment of the medical devices sector in Turkey.
International Perspective
Our team regularly advises international clients on Turkish market entry and ongoing operations.
Clear Communication
We provide practical, business-oriented legal advice in clear terms you can act upon.
Responsive Service
We understand the pace of business and provide timely responses to your legal needs.