Order № 633 “On the introduction of amendments to the Rules of state registration of medical devices” came into force in June 2018. This normative document introduced the amendments to the range of important processes, including the confirmation of sample import.

According to the Order, from now on the registration dossier should contain the hard copy of the sample import permission.

How are the samples for testings selected? What information is important for getting of sample import permission? How is customs clearance conducted? This article includes the answers on the above mentioned and other questions.

1. How are the samples for testings selected?

Samples of medical devices are imported on the territory of Russian Federation to conduct biocompatibility, technical and clinical testings. The main selection criteria of medical device type for biocompatibility testings is the presence of different materials and colorants in the composition of design variants of medical devices.  For technical testings it is engineering features. The number of required samples is strictly regulated be GOST 31214-2016.

2. Sample import permission.

Sample import permission is the document based on which it is possible to import medical devices for testings in the frame of state registration procedure.  To get this document, manufacturer of medical device should provide the following info about MD:

– Name of medical device with the indication of composition and number of elements.

– REF numbers or   assembly number (if available).

– Manufacturing date.

– Validity period.

– LOT (batch number) or serial number

It is important to note that all the above-mentioned parameters (except the manufacturing date and LOT) must comply with the technical documentation.

3. Customs clearance of samples.

The type of customs clearance is based primarily on its price. Thus, if the cost of sample is more than 200 EUR[1] including transportation expenses, the sender should declare the sample.  In this case, this refers to the procedure of temporary import.

In contrast with the import of “low-cost samples”, presence of which on the territory of Russian Federation after testings is not controlled now, import of samples requiring declaration is characterized with the defined timeframes. In most cases the samples are imported for 6-7 months. Their import requires import declaration, where indicated information about consignor, consignee, cargo and payments.  By the end of the terms of sample presence on the territory of Russian Federation export declaration is officially registered. The main purpose of this document is to prove that the sample left the territory of Russian Federation in the unchanged composition.

4. Required documents.

To declare samples in the frame of temporary import procedure the customs should be provided with the following documents about consignor, consignee and cargo:

– documents and information about the purpose of the temporary import of samples;

– information about identification characteristics of samples;

– documents and information justifying the application of full conditional exemption from payment of customs duties and taxes (if any);

– obligation to re-export of the temporary imported samples and other guarantees of proper performance of duties (including documents confirming the availability of security for payment of customs payments);

– plans and programs for carrying out activities using samples placed under the customs procedure for temporary importation;

– a statement on the expected time limits for temporary importation of samples;

5. Expenses

The cost of processing the import declaration is determined by the cost of the imported sample. The customs payments applicable for the temporary importation procedure include:

– Customs duties (depends on the type of goods)

–  Value-added tax (VAT)

– Customs fee

The customs procedure for temporary import is not applied to:

– Consumable materials and samples[2]

 

[1] LETTER dated 30 January 2018. N 01-11/04793 ON FILLING IN THE DECLARATION ON GOODS WHEN DECLARING GOODS, THE TOTAL COST OF WHICH IS LESS THAN 200 EURO.

[2] Customs code of EEU Article 219. Contents and application of the customs procedure for temporary import (admission)