If your medical device is classified as a REE or HFD: what should you do?
Sometimes during the authorization process of a medical device it appears that the device concerned cannot be imported into the Russian Federation with a temporary import permission issued by Roszdravnadzor (Federal Service for Surveillance in HealthCare). One of the reasons for such an inconvenience to occur is that the device concerned is a REE (radio-electronic device) or HFD (high-frequency device).
Let’s highlight the main points of this article:
- DEFINITION OF A REE AND HFD
- REFERENCES TO OFFICIAL DOCUMENTS REGULATING THE IMPORT AND HANDLING OF A REE AND HFD
- DO YOU NEED ANY DOCUMENTS TO BE ISSUED?
- GETTING PERMISSION FROM ROSKOMNADZOR (THE FEDERAL SERVICE FOR SUPERVISION OF COMMUNICATIONS, INFORMATION TECHNOLOGY AND MASS MEDIA)
- THE STEPS OF THE INSPECTION PERFORMED BY THE FSUE ‘GRFC’ (THE FEDERAL STATE UNITARY ENTERPRISE “GENERAL RADIO FREQUENCY CENTER”) AND RELATED FINDINGS
- OBTAINING THE STATEMENT FROM THE ROSKOMNADZOR REGISTRY
- OBTAINING THE MINPROMTORG (MINISTRY OF INDUSTRY AND TRADE) LICENSE
1.Definition of a REE and HFD:
High frequency devices are equipment or devices designed for the generation and usage of radio-frequency energy in the industry, science, medicine, consumer market sectors etc., except the electrical communication sector.
Radio electronic equipment means technical devices intended for the transmission and/or receiving of radio frequency waves and containing one or more transmitters and/or receivers or combinations of the aforementioned devices, including any related auxiliary equipment.
The following examples may be used to illustrate the aforementioned descriptions:
Equipment for HF-therapy, MRI scanners and electrical pacing devices are HFDs.
Wi-Fi and Bluetooth adapters, portable radios, bar code scanners and baby monitors are REEs.
2.This article is based on the legislations and regulations listed below:
А) Decision of the Board of the Eurasian Economic Commission dated April 21, 2015 No. 30, “On non-tariff regulatory measures”, issued to implement Import Regulations of the Eurasian Union for radio-electronic equipment and high frequency devices of a non-military nature (commercial), including those built-in or otherwise integrated into other goods.
Comment: This document, (particularly sub-clause 2.16, Appendix No.15) contains definitions for a REE and HFD, information on the customs clearance workflow for a REE and HFD, as well as information regarding documents, necessary to import a REE and HFD (license or permit), description of the general procedure for obtaining a license and/or permit, and lists all cases for which no permission for import is required, and import is not limited. Also, the procedure for completing the General Registry of the Eurasian Union is provided.
B) Decision of the Board of the Eurasian Economic Commission dated May 16, 2015, No. 45 “On the single conclusion template (permission document) for the import, export or transit of particular goods included in the Single List of Goods Traded with Third Countries Subject to Non-Tariff Regulatory Measures, and on instructions for completing this conclusion form”
Comment: This document defines the form of a temporary import permission document issued by Roskomnadzor.
C) Order of the Ministry of Communications of Russia No. 332, dated December 01, 2011, “On approval of the Procedure for completion of the Registry of radio-electronic equipment and high frequency devices of a non-military nature permitted for import into the Russian Federation”
Comment: This order defines the procedure for completing the Roskomnadzor Registry.
D) Order of the Ministry of Communications of Russia No. 118 dated March 23, 2016, “On approval of the Procedure for issuing a Conformity conclusion for radio-electronic equipment and high frequency devices of a non-military nature permitted for import into the Russian Federation, assessed on the basis of the specifications and conditions of usage approved by the State Radio Frequency Commission”
Comment: This document clarifies the procedure for the inspection of a REE and HFD to be carried out by the Radio Frequency Centre.
E) Order of the Ministry of Communications of Russia dated April 17, 2017, No. 189, “On the approval of the Administrative Procedure of the Federal Service for Supervision of Communications, Information Technology and Mass Media for issuing transport permits (other than for import into the Russian Federation) for a REE and HFD of a non-military nature, including those built-in or otherwise integrated into other goods, and for the import of a REE and HFD of a non-military nature by individuals for their personal use (if such permission is provided by the applicable legislation of the Russian Federation).”
Comment: This document defines the procedure for obtaining a temporary import permit (issued by Roskomnadzor).
Below definitions of terms used in this article are provided.
Unified Registry of the Eurasian Economic Committee (Single Registry) means the registry of a REE and HFD which do not need a license issued by Minpromtorg of Russia to be imported into the Russian Federation.
This registry has to be completed (as per Appendix No. 1 to the Document A) by means of proposals submitted by the Member States of the Eurasian Union.
To get access to the Single Registry, follow the link .
Roskomnadzor Registry – is a registry managed by Roskomnadzor. It contains information regarding REEs and HFDs which require a license issued by Minpromtorg of Russia in order to be imported.
To get access to the Roskomnadzor Registry, follow the link .
The List of exceptions (see Appendix No. 2 to Document А) is a list of REEs and HFDs,which may be imported without obtaining any permission documents, licences, or provisions of information from the Single Registry(such as, for example, standard Bluetooth or Wi-Fi adapters, microwave ovens, hearing aid devices etc.).
3. Do you need any documents to be issued?
- First, you have to read Document A (sub-clause 2/16, Appendix 15).
- Check whether the device concerned is included into the List of exceptions
(Appendix No. 2 to the Document A).
- When the device concerned is a HFD, check if its rated parameters (frequency and output power) are consistent with those provided in the Bandwidth List or in the List ofrated radio frequencies for HDFs (Annex to Appendix No. 2 to Document A).
When your device is in the exception list, you do not need any documents to be issued. Most probably, the customs office will ask for a statement of the Specifications in order to confirm that the device falls into the range of parameters subject to the exception rules.
However, if the exception is not applicable, first of all you must to clarify if the device in question requires a conclusion from the FSUE ‘GRFC’ regarding compliance of the device concerned with the specifications approved by the Radio Frequency Centre.
If this device was already imported previously, you need to obtain a statement from the Roskomnadzor Registry (please use the link provided to check the Registry in advance), and then submit this document to Minpromtorg of Russia asking for an import license for the relevant REE and/or HFD.
If the device concerned is not listed in the Roskomnadzor Registry, it will be necessary to obtain a temporary import permission from Roskomnadzor and pass the FSUE ‘GRFC’ inspection.
In order to get a better understanding, let’s follow the proposed workflow step by step.
4. So, you need to obtain a temporary import permission from Roskomnadzor. This procedure is regulated by the Document E in our list.
In order to obtain a permission for temporary import (individual document for each version of the device concerned), the applicant shall complete the application form which is in fact a draft of the permission document, and issue the application letter containing the required information (as per Document E). You can find templates of the application form and application letter on the web site of Roskomnadzor.
Please submit all documents to the following address: Kitaygorodsky proezd, 7, building 2-g. Moscow, Russian Federation, 109074
Within 15 business days you shall obtain a reply: either the permission document, or a refusal with justification of such decision.
When importing the goods, you shall provide a scanned copy of the permission document to the customs authority.
This document is valid for up to 6 months, and, if necessary, it has to be renewed by means of submitting another application and application letter to the Roskomnadzor.
In the event of errors or any changes, a new permission document shall be obtained.
5. After the import of the device concerned into the RF, it is necessary to apply to the FSUE ‘GRFC’ for the inspection in order to check compliance of the specifications of the devices concerned (RRE and/or HFD) with the relevant RF regulations.
This inspection has to be carried out in accordance with Order of the Ministry of Communications of Russia No. 118, dated March 23, 2016 (see Document D of our list).
This inspection has two steps, namely documents inspection and instrumental inspection. First you shall submit the application as per the approved form (please refer to the website of the Radio Frequency Centre.
It is possible to sign the application and other related documents via an enhanced encrypted and certified digital signature and submit all documents via the Applicant’s account.
Important: Each model or variant of the device requires an individual application.
Your application will be reviewed within 3 business days for the completeness and authenticity of the data provided; as a result, you will receive a contract for signature, and the costs of the first step of inspection will be invoiced to you.
Within 5 days after receiving the contract and invoice you shall make the payment, sign the contract and send one signed copy back to the RFC.
The estimate of costs for each step of the inspection are available on the website of the FSUE ‘GRFC’:
If the documentary inspection finds that the device concerned is not listed either in the Roskomnadzor Registry or in the Single Registry or in the List of exceptions, you will be invoiced for the second step of the inspection.
As the result of this step, the Conclusion will be completed, stating the compliance or non-compliance of the specifications of the related REE and/or HFD with the applicable regulations of the RF. Also, one of the following outcomes shall be stated:
- The REE or HFD shall be included in the Roskomnadzor Registry,
- The REE or HFD is already listed in the Roskomnadzor Registry,
- The REE or HFD is already listed in the Single Registry,
- The REE or HFD is already included in the List of exceptions,
- The device concerned is not qualified as a REE or HFD.
Those findings will be submitted to the Roskomnadzor within two business days, and you need not undertake any further actions.
Note. Please remember that the equipment or device concerned shall be registered in Roszdravnadzor as a medical device.
6. You also shall obtain the statement from the Roskomnadzor Registry (in the event that the device concerned was included in this registry). To do that, download the application form for the request of information from the Roskomnadzor Registry, complete it and send it by mail or email to the relevant address of Roskomnadzor.
7. After the statement from the Roskomnadzor Registry is received, you will have to obtain the license from Minpromtorg of Russia for the import of the radio electronic equipment and high frequency devices. This is the subject of a particular article; we mention only that issuing the license takes 15 business days, and the official fee is 7500 rub.
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