Healthcare
Medical Device and Pharmaceutical Company
TİTCK registration, product tracking system notification, import permits and marketing authorisation.
- Regulator
- Turkish Medicines and Medical Devices Agency
- Required company form
- Any form
- Sector
- Healthcare
- Licensing time
- 3–9 months
Companies operating in medical devices and pharmaceuticals must be registered with the Turkish Medicines and Medical Devices Agency and notify their products to the Product Tracking System. Importer, manufacturer and authorised representative roles carry different obligations. Pharmaceutical marketing authorisation is a far longer process requiring clinical data and GMP inspection.
Requirements
- Company registration with TİTCK and product tracking system notification
- Product classification and provision of declarations of conformity or CE certificates
- For imports, an authorised representative agreement and free sale certificate
- Compliance with good distribution practices in storage and distribution
- For pharmaceuticals, a marketing authorisation application, GMP inspection and price approval
Let's start with a conversation
In a free 30-minute call, let's clarify which company structure and which incentives fit you. Non-binding, but useful.