ÜTS Registration for Foreign Manufacturers: The Document Set

Aug 2

2 min read

Every medical device placed on the Turkish market must be recorded in ÜTS, the national Product Tracking System. ÜTS registration is not a filing that happens after launch — without it the device cannot lawfully be placed on the market at all.

What ÜTS registration requires at stage one

The company record establishes who you are in the system: manufacturer, importer, distributor or authorised representative. It requires a Turkish tax number, a MERSİS trade registry record and a qualified electronic signature.

A responsible manager must also be appointed and their qualification and employment documentation recorded. This is a named individual with defined obligations, not a formality, and changes to that appointment must be updated in the system.

Stage two: certificates and products

Certificates are registered before products. Where a notified body is involved, the CE certificate is recorded and linked. The EU declaration of conformity is required for every device regardless of class — it is the single document common to Class I and Class III alike.

Product registration then follows, device by device, with catalogue information, labelling data, EMDN codes and UDI-DI information for each variant placed on the market.

Where files come back

Four patterns account for most rejections and corrections.

Authorised representative details in the ÜTS record not matching the EUDAMED registration. Two databases, one company, two different spellings of the same address — and the file stops.

Declaration of conformity content not matching the registration. Where the declaration cites a directive rather than the current regulation, or omits EMDN or GMDN codes, the record cannot be completed.

Movement notifications not filed. Placing on the market, sale and transfer are individually notifiable events in ÜTS. Manufacturers accustomed to systems where registration is a one-off filing miss this consistently.

Responsible manager changes not updated. The appointment is recorded against the company; when the person leaves, the record is wrong until it is corrected.

How this connects to your EU file

If you are already registered in EUDAMED, much of the underlying data is the same: UDI-DI records, EMDN codes, the declaration of conformity, certificate references. The two systems are separate but the data behind them is not, and inconsistency between them is itself a finding.

Under the Customs Union arrangement a single authorised representative mandate can serve both markets. The filings remain separate; the responsibility does not have to be.