Medical Devices
We practice medical device law, and providing legal service upon the Turkish Medical Devices Act aligned with EU standards covers device classification and technical requirements.What is Medical Device Law?
Medical device law is a branch of law that includes legal regulations and responsibilities regarding the production, import, export, sale, use, maintenance and control of medical devices and also representing the medical device producer, importer before courts in litigation and arbitrations. Medical devices include any instrument, device, machine, implant, software, material or other product that is applied to or resides in the human body. Medical device law establishes the standards, rules and regulations necessary to ensure the safety, effectiveness, quality and suitability of medical devices.
Medical device law is applied both nationally and internationally. At the national level, medical device law in Turkey is mainly enforced by the Ministry of Health, TİTCK (Turkish Medicines and Medical Devices Agency) and TURKAK (Turkish Accreditation Agency). The Ministry of Health has issued the Medical Device Regulation to market and monitor medical devices via the National Assembly of Turkey (TBMM). This regulation regulates the definition, classification, licensing, labeling, advertising, technical service and recall of medical devices. It also establishes rights and obligations for manufacturers, importers, distributors and users of medical devices.
At the international level, medical device law is determined by organizations such as the European Union (EU) and the World Health Organization (WHO). The EU has published the Medical Device Directives to ensure the free movement of medical devices. These directives include safety and performance requirements, conformity assessment procedures and market surveillance of medical devices. WHO has created the Medical Device Policy to increase the global access and quality of medical devices. This policy covers the needs analysis, planning, purchasing, management and evaluation processes of medical devices.
Medical device law contributes to public health by increasing the quality and safety of healthcare services. It is necessary to consult an expert lawyer for any questions and problems that may arise regarding medical device law.
Medical Devices and the Turkish Regulatory Framework
The Turkish healthcare landscape continues to evolve, presenting exciting opportunities for medical device manufacturers and distributors. However, navigating the regulatory environment can be complex. To ensure smooth market entry and sustained success, understanding the Turkish Medical Devices Act is paramount.
What is the Turkish Medical Devices Act?
Enacted in 2021, the Turkish Medical Devices Act (Act No. 31499) governs the safety, efficacy, and quality of medical devices marketed and used within the country. It aligns with the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), making it easier for manufacturers to comply with both sets of regulations.
Key aspects of the Act include:
Classification of medical devices: Devices are categorized based on their risk level, determining the rigorousness of the conformity assessment process.
Technical requirements: Manufacturers must demonstrate their devices meet essential safety and performance requirements.
Conformity assessment procedures: Depending on the classification, devices must undergo conformity assessment by notified bodies or the Turkish Medicines and Medical Devices Agency (TİTCK).
Market surveillance and post-market activities: TİTCK monitors the market and takes corrective action where necessary. Manufacturers are responsible for vigilance and post-market reporting.
What does this mean for manufacturers and distributors?
Comply with the Act's requirements: Ensure your devices meet the relevant classification and undergo the stipulated conformity assessment procedures.
Register your devices: All medical devices marketed in Turkey must be registered with TİTCK.
Maintain technical documentation: Compile and maintain comprehensive technical documentation demonstrating compliance.
Appoint a responsible person: Designate a representative within Turkey responsible for regulatory compliance.
The Lawyers Practice on Medical Device
At ISTLEGAL Attorneys at Medical Device Law, we have a dedicated team of legal professionals experienced in navigating the complexities of the Turkish medical devices regulatory framework. We can assist you with:
- Classification and certification of your devices
- Selecting the appropriate conformity assessment procedure
- Preparing and submitting regulatory documentation
- Liaising with TİTCK and notified bodies
- Addressing compliance challenges
- Applying for dispute resolution
- Representing before courts and authorities
By partnering with us, you can ensure a smooth and compliant entry and representation into the Turkish medical devices market and represent by the specialists for the disputes. Contact us today to learn more about how we can support your business objectives.
Disclaimer: This post is for informational purposes only and does not constitute legal advice. Please consult with a qualified legal professional for guidance specific to your situation.