The Turkish Medicine and Medical Devices Authority (TITCK) has updated a number of regulations in 2023. These updates are designed to improve the safety and quality of medical devices in Turkey.
Some of the key changes include:
- Increased focus on risk management: TITKC is now requiring manufacturers to conduct a comprehensive risk analysis of their devices and take steps to mitigate any identified risks.
- More stringent requirements for clinical data: TITKC is now requiring manufacturers to provide more clinical data to support the safety and performance of their devices. This data must be gathered from clinical trials that are conducted in accordance with Good Clinical Practice (GCP) guidelines.
- New requirements for notified bodies: TITKC is now requiring notified bodies, which are the organizations responsible for assessing the conformity of medical devices to the requirements of the regulation, to be accredited by a recognized accreditation body and to have the necessary expertise and resources to assess medical devices.
These are just some of the key changes to the TITKC regulations. Manufacturers of medical devices should carefully review the regulations to ensure that they are in compliance with the new requirements.
The updates to the TITKC regulations are a reminder that manufacturers of medical devices need to be proactive in staying up-to-date on regulatory changes. By taking steps to comply with new regulations, manufacturers can help to protect their customers and patients.
In addition to the updates to the regulations, TITKC has also taken a number of other steps to improve the safety and quality of medical devices in Turkey. These steps include:
- Establishing a new risk management system: TITKC has established a new risk management system that will help manufacturers to identify and assess the risks associated with their devices.
- Creating a new database of medical devices: TITKC has created a new database of medical devices that will allow manufacturers to track the performance of their devices and to identify any potential problems.
- Providing training and education to manufacturers: TITKC is providing training and education to manufacturers to help them to comply with the new regulations.
The updates to the TITKC regulations and the other steps that TITKC is taking are a sign of the Turkish government's commitment to ensuring the safety and quality of medical devices in Turkey. These changes will help to protect patients and to ensure that the Turkish medical device industry remains competitive in the global market.
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