Registration Procedures

HOW TO GET YOUR DEVICES REGISTERED IN ITALY?

Documentation needed:

In order to proceed with the device registration Obelis will need from you the following information in an electronic format:

- 1 manufacturer’s representative designation document signed (template to be provided)
- 1 list of the Medical device (those which are / will be sold in Italy)
- 1 technical file for each product (.pdf or .doc)
- 1 copy of valid CE certificate
- 1 copy of valid ISO certificate
- 1 GMDN codes of the products to be registered *.
Registration number will be provided at the end of the process.

* The device registration in Italy has to be made also per GMDN code. If you are not familiar with GMDN, the Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors for the identification of medical devices and other Healthcare related products.

If you do NOT know the GMDN codes for your products, Obelis can find them out for you, this is a separate service we provide to our clients. We would need from you a very accurate product description (usage, composition).

Process & Time frame (6-8 weeks) dependent on:

1. All the documents have been provided to Obelis’ Notification department.
2. The number of products in question (time might be longer in case of a large quantity of products).
3. The Italian Competent Authority promptitude.
4. The Italian Database functionality.

Additional Fees (Not Obelis fees):
There will be a Tax in the value of 100.00€ per file submitted by the Italian Authorities.

For further inquiry and to begin the Italian Device Registration Process please contact Obelis C.O.O. Mr. Doram Elkayam at