Turkey Product Registration & Certification
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
- Food Supplement Notification: Food supplements require notification to Turkish Food and Feed Administration (TGDF) with complete product information
- Cosmetic Notification System: Cosmetics must complete notification through TİTCK Cosmetic Product Notification System ensuring safety information filing
- Legal Representative Responsibility: Medical devices require Turkish Authorized Representative; cosmetics need Turkish Responsible Person
- 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
Turkey Specific Requirements
- Strict Turkish Single-language System: All product 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
- Dual Legal Representative System: Medical devices require Turkish Authorized Representative (technical); cosmetics require Turkish Responsible Person (safety)
- Food Supplement Notification Management: Food supplements follow notification system rather than registration requiring complete product dossier filing
- Cosmetic EU-harmonized System: Cosmetics adopt product notification system based on EU Cosmetic Regulation maintaining high coordination with EU
- CE Certification Strategic Value: Values CE certification as important technical assessment basis simplifying Turkish registration processes
- Importer Registration Requirements: All importers must register in Turkish regulatory systems maintaining compliant import and distribution records
- Eurasian Bridge Regulatory Position: As key market connecting Europe and Asia, regulatory requirements blend EU models with Turkish characteristics
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 registration approval, market surveillance and post-market monitoring of medical devices, pharmaceuticals and cosmetics
TFCAM
Turkish Food and Feed Administration (TFCAM)
Under Turkish Ministry of Agriculture and Forestry, responsible for regulation, registration and market surveillance of food, food supplements and foods for special nutritional purposes
TSE
Turkish Standards Institution (TSE)
Responsible for developing Turkish Standards (TSE Standards), conducting product certification and quality system certification to ensure product quality and safety meet Turkish requirements
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
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Notification
- Complete Product Information File (PIF)
- Cosmetic Product Safety Report (CPSR)
- Compliance with Turkish Cosmetics Regulation
- Turkish product labeling
- Good Manufacturing Practice certificate
- Product stability test reports
- Microbiological testing reports
Main Process
- Ingredient compliance assessment
- Safety assessment report completion
- Product information file preparation
- Cosmetic notification submission
- Label compliance review
- Market access completion
Registration Timeline
4-7 months
Official Fees
TRY 7,000 - 50,000 (including notification and annual renewal fees)
Service Fees
$9,000 - $24,000
Regulatory System Overview
TİTCK
Turkish Medicines and Medical Devices Agency (TİTCK)
Independent regulatory agency under Turkish Ministry of Health, responsible for registration approval, market surveillance and post-market monitoring of medical devices, pharmaceuticals and cosmetics
TFCAM
Turkish Food and Feed Administration (TFCAM)
Under Turkish Ministry of Agriculture and Forestry, responsible for regulation, registration and market surveillance of food, food supplements and foods for special nutritional purposes
TSE
Turkish Standards Institution (TSE)
Responsible for developing Turkish Standards (TSE Standards), conducting product certification and quality system certification to ensure product quality and safety meet Turkish requirements
Cosmetics Registration Process
Ingredient Compliance
Verify all ingredients comply with Turkish permitted substances list and restrictions
Safety Assessment
Complete Cosmetic Product Safety Report (CPSR) by qualified safety assessor
Product Information File
Prepare complete Product Information File (PIF) in Turkish
Cosmetic Notification
Submit product information through TİTCK Cosmetic Product Notification Portal (CPNP)
Responsible Person
Appoint responsible person located in Turkey
Food Supplements Registration
Regulatory Requirements
- Food Supplement Notification
- Ingredient safety and quality evidence
- Compliance with Turkish Food Supplement Regulation
- Turkish labeling and instructions
- Good Manufacturing Practice certificate
- Ingredient analysis reports
- Scientific justification for nutrition claims
- Stability study data
Main Process
- Product classification determination
- Technical documentation preparation
- Safety evidence collection
- Notification submission
- Label compliance review
- Market access completion
Registration Timeline
5-9 months
Official Fees
TRY 12,000 - 75,000 (including notification and registration fees)
Service Fees
$11,000 - $28,000
Regulatory System Overview
TİTCK
Turkish Medicines and Medical Devices Agency (TİTCK)
Independent regulatory agency under Turkish Ministry of Health, responsible for registration approval, market surveillance and post-market monitoring of medical devices, pharmaceuticals and cosmetics
TFCAM
Turkish Food and Feed Administration (TFCAM)
Under Turkish Ministry of Agriculture and Forestry, responsible for regulation, registration and market surveillance of food, food supplements and foods for special nutritional purposes
TSE
Turkish Standards Institution (TSE)
Responsible for developing Turkish Standards (TSE Standards), conducting product certification and quality system certification to ensure product quality and safety meet Turkish requirements
Food Supplements Registration Process
Product Classification
Determine product falls under food supplement category per Turkish food regulations
Technical Documentation
Prepare ingredient analysis, safety evidence, nutrition claims in Turkish
Notification Submission
Submit notification to Turkish Ministry of Agriculture and Forestry Food and Feed Administration
Label Review
Ensure compliance with Turkish food labeling regulations and nutrition claim requirements
Importer Registration
Importers must register in Turkish Food Registration System (TÜRKSAP)