The Turkish Ministry of Health (TMH) recently published a draft regulation to update its current, European Union-aligned Medical Device Regulation. While most of the requirements proposed in the draft regulation are identical to those stated in the EU’s Medical Device Regulation (MDR), there are some that are unique to Turkey.
Here is a summary of some of the changes put forth by the new draft regulation:
- Any labeling or promotion of the purpose of the product that includes misleading legal information (e.g. trademarks, pictures, etc.) is prohibited. Misleading product information can promote improper use of the device and/or fail to inform users and patients of the risks associated with the use of the product.
- Manufacturers must oblige to making routine updates to their EU Declaration of Conformity, having a risk management system, conducting clinical evaluations for the devices, updating technical documentations, and maintaining a quality management system.
- At least one person within the manufacturer’s organization must be solely responsible for regulatory affairs.
- A new international registry system for medical devices, similar to the Unique Device Identification (UDI) system, will be established. This will be another step manufacturers must go through on top of fulfilling the local registration requirements established by the Turkish Ministry of Health.
- Patient and commercial data are required to be protected, especially the information pertaining to investigations and audits.
Due to the similarities between the EU MDR and Turkey’s new draft regulation, the draft regulation is likely to have a similar transition period upon legalization .The latest version of the EU MDR is in the middle of a three-year transition period and is set to go into full effect by May 2020. More information about current EU regulations can be found here.