Turkey Medical Device Registration
Important Notes
- Mandatory Turkish Language Requirements: All technical documents, labels, and instructions must be in Turkish requiring translation by Turkish-certified translation companies.
- TİTCK Registration System: Medical devices must register with Turkish Medicines and Medical Devices Agency (TİTCK) to obtain registration certificates.
- Legal Representative Responsibility: Medical devices require Turkish Authorized Representative to assume regulatory responsibilities.
- Registration Validity Management: Medical device registration certificates valid for 5 years requiring renewal application 6 months in advance with updated technical files.
- Multi-level Document Authentication: All foreign documents require origin country notarization, Turkish consular authentication, and Turkish Foreign Ministry legalization.
- Clinical Trial Requirements: High-risk medical devices may require Turkish local clinical trial data or sufficient clinical literature support.
- CE Certification Strategic Value: CE certification serves as important technical assessment basis simplifying Turkish registration processes.
- Localized EU Framework Implementation: Medical device registration based on EU Medical Device Directive/Regulation framework supplemented with Turkey-specific requirements.
Turkey Specific Requirements
- Strict Turkish Single-language System: All medical device information must be in Turkish reflecting Turkish language sovereignty policy.
- Localized EU Framework Implementation: Medical device registration based on EU Medical Device Directive/Regulation framework supplemented with Turkey-specific requirements.
- Mandatory Local Authorized Representative: Medical devices require Turkish Authorized Representative for regulatory affairs.
- CE Certification Strategic Value: Values CE certification as important technical assessment basis simplifying Turkish registration processes.
- Registration Validity Management: Medical device registration certificates valid for 5 years requiring renewal application 6 months in advance.
- Multi-level Document Authentication: All foreign documents require origin country notarization, Turkish consular authentication, and Turkish Foreign Ministry legalization.
- Eurasian Bridge Regulatory Position: As key market connecting Europe and Asia, regulatory requirements blend EU models with Turkish characteristics.
- High-standard Medical Device Review: TİTCK maintains high standards for medical device quality and technical requirements.
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate
- Risk-based classification (Class I, IIa, IIb, III)
- Complete Turkish technical documentation
- Quality Management System Certificate (ISO 13485)
- Turkish labeling and instructions for use
- Certificate of Free Sale
- CE Certificate of Conformity
- Clinical Evaluation Report (if applicable)
- Biocompatibility test reports
Main Process
- Product classification determination
- Technical documentation preparation and translation
- Quality management system review
- TİTCK registration application submission
- Local authorized representative appointment
- Technical documentation assessment
- Registration certificate acquisition
Registration Timeline
9-18 months
Official Fees
TRY 25,000 - 350,000 (including application, evaluation, and registration fees)
Service Fees
$16,000 - $50,000
Regulatory System Overview
TİTCK
Turkish Medicines and Medical Devices Agency (TİTCK)
Independent regulatory agency under Turkish Ministry of Health, responsible for medical device registration approval, market surveillance and post-market monitoring.
TSE
Turkish Standards Institution (TSE)
Responsible for developing Turkish Standards (TSE Standards), conducting product certification and quality system certification to ensure medical device quality and safety meet Turkish requirements.
Ministry of Health
Turkish Ministry of Health
Responsible for developing national health policies, medical device regulatory frameworks, and public health programs, overseeing TİTCK operations.
Medical Devices Registration Process
Product Classification
Determine risk classification according to Turkish medical device regulations (Class I, IIa, IIb, III)
Technical Documentation
Prepare complete Turkish technical documentation including specifications, test reports, clinical data
Quality System
Provide ISO 13485 certificate or evidence of compliance with Turkish quality system requirements
Local Representative
Appoint authorized representative located in Turkey
TİTCK Registration
Submit complete registration application to Turkish Medicines and Medical Devices Agency