How do I register a medical device in Turkey?
The registration must be made by the entity placing the device on the market or through an authorised representative. The online registration is made through the Product Tracking System, which replaced the Turkish National Databank for Pharmaceuticals and Medical Devices of the MoH.
Which devices need to be registered with ANVISA before selling?
Class II-IV devices are subject to ANVISA review prior to approval. Class II devices are registered via the Cadastro route, while Class III and IV devices are registered via the more complex Registro route.
How long does it take to register medical device in Turkey?
TIMEFRAME: Product Notification in Product Tracking System (UTS) will take approximately 1 week. LOCAL FEES (New Application): No fee is required for the product notification.
Is Turkey’s new medical device regulation unique to Turkey?
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.
What is a new international registry system for medical devices?
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.
Why do I need a local authorized representative in Turkey?
Manufacturers without local presence in Turkey must appoint a Local Authorized Representative. Thanks to agreements with the European Union, medical devices that obtained the CE marking benefit from a faster and more streamlined registration process.
Who is responsible for medical device regulatory affairs?
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.