Unlocking Turkish Markets
Product registration UAE: learn about Turkish regulations, key bodies, and what you need to know for a smooth registration process in Turkey.
6/21/20242 min read
Product Registration in Turkey: An Essential Process
Why Is Product Registration Important?
Product registration plays a pivotal role in ensuring the safety, quality, and compliance of pharmaceuticals, medical devices, cosmetics, and other related products within the Turkish market. Here’s why it matters:
Legal Compliance: Registering products with relevant authorities ensures regulatory approval for distribution, marketing, and sales. Compliance with local laws is essential.
Safety and Quality Assurance: By undergoing the registration process, companies contribute to restricting the trading of counterfeit or unsafe products. Turkish authorities rigorously verify product safety and quality.
Warranty and Technical Support: Registration facilitates warranty claims, technical assistance, and extends warranty periods beyond the manufacturing date.
Importance of Product Registration in Turkey
Product registration matters for several reasons:
- Market Access: Registration grants legal entry into the Turkish market.
- Credibility: Registered products gain trust among healthcare professionals and patients.
- Growth Opportunities: Approval opens doors to a thriving healthcare market.
Key Regulatory Bodies in Turkey:
1. Ministry of Health (MoH)
The MoH oversees the pharmaceutical sector through its independent institution, the Pharmaceutical Product and Medical Device Institution (Institution).
It plays a crucial role in shaping healthcare policies and regulations related to pharmaceuticals, medical devices, and cosmetics.
2. Turkish Medicines and Medical Devices Agency (TITCK)
The TITCK is the primary regulatory authority responsible for pharmaceuticals and medical devices.
Manufacturers or their authorized representatives must register medical devices with the TITCK before placing them on the market. Detailed technical documentation demonstrating compliance with safety, efficacy, and quality standards is required.
3. Social Security Institution (SSI)
While not directly related to product registration, the SSI impacts Turkey's healthcare financing and access to medical services.
Navigating the Registration Process
The product registration journey involves several steps, including:
Submission of data, documents, and samples for evaluation.
Rigorous assessment by regulatory authorities to ensure safety, quality, and compliance.
Challenges and Considerations
Documentation: Companies must prepare legalized contracts, registration certificates, and detailed product lists.
Quality Assurance: Adherence to Good Manufacturing Practice (GMP) standards is crucial.
Fees and Pricing: Understanding associated costs is essential.
Remember, seeking professional assistance ensures a smooth entry into the Turkish market. If you have more questions or need further details, please ask! (Get Your free consultation here!)
- Required Documentation for Registration:
- Conformité Européenne (CE) Mark Certification: Mandatory for all medical devices, indicating compliance with EU regulations.
- Technical File: Detailed design, manufacturing, risk analysis, clinical evaluation, and safety data.
- Quality Management System (QMS) Certificate: Demonstrates adherence to ISO 13485 standards.
- Declaration of Conformity: Affirms compliance with relevant regulations.
- Letter of Authorization/Authorized Representative Certificate (ARC): For non-Turkish manufacturers, appointing a local representative is crucial.
Working with a local authorized representative in Turkey can streamline the registration process.
Click here to collaborate with professionals and streamline the process of registering your product in Turkey.
Understand the critical steps for registering products in Turkey and Oman.
