Greetings from
Freyr Turkey
With profound economic transformation and with special focus given to Free Healthcare Zones, advantageous to the public and the companies operating, the Republic of Turkey offers a good scope of business for foreign medicine and medical device manufacturers. The Ministry of Health, Turkey oversees the market authorizations and registrations in the region. With the recent transformation of aligning medical device regulations with those of the European rules and regulations, navigating Turkish Regulatory landscape with little information might pose a challenge for foreign manufacturers.
Assisting companies design risk-free compliance strategies for successful authorizations to market their products in Turkey, Freyr as an exclusive Regulatory partner provides Regulatory procedural assistance in terms of registrations, approvals, dossier preparations, submissions etc. Freyr’s Regulatory services in Turkey span across:
Industries We Serve in Turkey
Increased healthcare spending in Turkey has resulted in growing demand for medicinal products. As the Turkish Medicines and Medical Devices Agency (TMMDA) reviews and approves the medicinal products’ marketing in the country, aligning with its unique requirements for compilation and submission of dossiers in CTD format and conversion to paper format for legacy products can prove quite challenging without expert assistance. Additionally, gaining a foothold amid rising competition requires informed decision, effective Regulatory and market pathway for successful product launch and adjusting to changes in trends in extended product life cycle.
The Turkish medical device market has seen significant and consistent growth over the past decade. From 2021onwards, Turkey Medical Device Registration Requires to abide by the EU EU Medical Devices Regulation (MDR) 2017/745 and In Vitro Diagnostics Medical Devices Regulation (IVDR) 2017/746. This enhanced international trade leading several global companies to launch their medical devices in the country.
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory Affairs & Regulatory intelligence
- Registration pathways
- Market Authorizations
- Life Cycle Management
- Regulatory Submissions
- BE/BA summary reports, SmPCs and PILs
- eCTD submissions
- Product Information File (PIF)
- Cosmetic Product Safety Report (CPSR)
- Material Safety Data Sheet (MSDS) preparation
- Legal representation
- Orphan drug designation
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase – with the Ministry of Health, Turkey
- Expert Regulatory team
- End-to-end Regulatory affairs consultancy service and support
- Accelerated device approvals for faster time-to-market
- Proactive and Collaborative approach