Order of Russian Government 661n

MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION
ORDER

Dated 30 June, 2020, No. 661n

On Approval of the Procedure for the Import of Medical Devices into the Territory of the Russian Federation for the Purposes of Marketing Authorisation

In accordance with part 6 of Article 38 of Federal Act dated 21 November, 2011 No. 323-ФЗ “On the basic principles of public healthcare in the Russian Federation” (Corpus of Legislation of the Russian Federation, 2011, No. 48, art. 6724) and sub-paragraph 5.2.186 of the Regulation on the Ministry of Healthcare of the Russian Federation, approved by order of the Government of the Russian Federation dated 19 June, 2012, No. 608 (Corpus of Legislation of the Russian Federation, 2012, No. 26, art. 3526),

I hereby order

  1. To approve this Procedure for the Import of Medical Devices into the Territory of the Russian Federation for the Purposes of Marketing Authorisation.

  1. Consider as null and void order of the Ministry of Healthcare of the Russian Federation dated 15 June, 2012,. No. 7n “On Approval of the Procedure for the Import of Medical Devices into the Territory of the Russian Federation for the Purposes of Marketing Authorisation” (as registered by the Ministry of Justice of the Russian Federation on 25 July, 2012 reg. No. 25013).

  1. This Order becomes effective from 01 January 2021.

Minister M. A. Murashko

Registered

In the Ministry of Justice of the Russian Federation on 28 September, 2020,

reg. No. 60070

Procedure for the Import of Medical Devices into the Territory of the Russian Federation for the Purposes

of Marketing Authorisation.

APPROVED

By order of the Ministry of Healthcare of the Russian Federation

Dated 30 June, 2020, No. 661n

  1. This Procedure defines the rules for the import of medical devices into the territory of the Russian Federation for the purposes of marketing authorisation, including the need to implement amendments to the documents comprising the marketing authorisation dossier, for which amendments various tests or trials are required, including technical tests, toxicology tests, clinical trials and tests related to the approval of measuring tools type (for medical devices which are used as measuring tools within the scope of State regulation of the assurance of uniformity of measurements) (hereinafter “implementation of amendments to the registration documents”).

  1. The import of medical devices into the territory of the Russian Federation is possible on the basis of the related import permit (hereinafter “Import Permit for Medical Devices”) issued by the Federal Service for Overseeing Healthcare (hereinafter “Roszdravnadzor”) in the form of an e-document signed with a reinforced qualified e-signature, which is placed in the personal area of the applicant on the Single State Services Portal (hereinafter “SSSP”) and registered in the Register of Issued Import Permits for Medical Devices and Notifications of Rejected Applications for Import Permits for Medical Devices, which is part of the automated information system of Roszdravnadzor (hereinafter “the Register”).

Medical devices for software classified as medical devices do not require an import permit.

  1. When a medical device to be imported is produced by a legal entity or private entrepreneur registered within the territory of the Russian Federation, while the manufacturing site is located outside the territory of the Russian Federation, such medical device requires an import permit.

  1. The import of medical devices into the territory of Russian Federation for the purposes of marketing authorisation, including the need to implement amendments to the registration documents, has to be performed by the manufacturer of the medical device or by the authorised representative of the manufacturer (either a legal entity or private entrepreneur registered within the territory of the Russian Federation), to which the manufacturer has to delegate specific authority to represent the manufacturer in terms of the circulation of the medical device in question within the territory of the Russian Federation, including the related compliance evaluation procedures and marketing authorisation issues, and which can act as a legal holder of the Marketing Authorisation Certificate (hereinafter “the Applicant”).

  1. The number of representative samples of the medical device to be imported into the territory of the Russian Federation for the purposes of marketing authorisation, including implementation of amendments to the registration documents, has to be determined by the Applicant taking into account the recommendation of organizations responsible for the technical tests, toxicology tests, clinical trials and tests related to the approval of the type of measuring tools (for medical devices which are used as measuring tools within the scope of State regulation of the assurance of uniformity of measurements), depending on the class of potential risk of the application of the medical device concerned, and on the scope of the required tests or trials.

  1. An Import Permit for a Medical Device is a single-use document and therefore covers only a single import operation for the medical device concerned for the purpose of its marketing authorisation within the territory of the Russian Federation, including the need for the implementation of amendments to the registration documents. An Import Permit for a Medical Device is valid for one year starting from the date when it is issued.

  1. An Import Permit for a Medical Device has to state the following information:

  • the name of the service provider (Roszdravnadzor);

  • name of the medical device, including model (if applicable), or variant of implementation (if applicable), or contents of the device set/kit (if applicable), and/or accessories (if applicable), quantity or number of items and/or serial number or batch number, date of manufacture (production) of the medical device concerned and its service life term or expiry term;

  • information regarding the date of issue and number of the MAC (if an Import Permit is required for the import of the medical device necessary for the implementation of amendments to the registration documents of a medical device already registered);

  • name of the manufacturer of the medical device in question and its location (address); address of the manufacturing (production) site of the medical device;

  • information regarding the Applicant:

  1. a) full and, if applicable, abbreviated name of the Applicant, brand name (if applicable), type of legal entity, its physical location address, tax payer identification number, and registration number according to the State Register of Legal Entities;

  1. b) full name (including patronymic, if applicable) of the private entrepreneur, his/her residential address, information related to the personal identification document, tax payer identification number, and registration number according to the State Register of Private Entrepreneurs;
  • date and number of the Import Permit;
  • validity term of this Import Permit.

  1. In order to obtain an Import Permit for the medical device, the Applicant has to submit an application in the form of an e-document, signed with a reinforced qualified e-signature, stating the following information:

  • name of the medical device, including model (if applicable), or variant of implementation (if applicable), or list of parts of the device set/kit (if applicable), and/or accessories (if applicable), the quantity or number of items and/or serial number or batch number, manufacturing date of the medical device concerned and its service life term or expiry term;

 

  • information regarding the date of issue and number of the MAC (if an Import Permit is required for the import of the medical device necessary for the implementation of amendments to the registration documents of a medical device already registered);

  • intended use of the medical device concerned, as established by the producer;

  • information regarding the Applicant:

  1. a) full and, if applicable, abbreviated name of the Applicant, brand name (if applicable), type of legal entity, its physical location address, tax identification number, and registration number according to the State Register of Legal Entities, phone number and email (if applicable);

  1. b) full name (including patronymic, if applicable) of the private entrepreneur, his/her residential address, information related to the personal identification document, and registration number according to the State Register of Private Entrepreneurs, phone number and email (if applicable);

  • name of the manufacturer of the medical device in question and its location (address); address of the manufacturing (production) site of the medical device;

  • information about the organizations responsible for the implementation of the required technical tests, toxicology studies, clinical trials, as well as the trials intended to approve the type of measuring tools (for medical devices which are used as measuring tools within the scope of State regulation of the assurance of uniformity of measurements), stating the date and number of the related contract for test or trial services;

  • for organizations responsible for the implementation of the required technical tests, toxicology studies, clinical trials, as well as the trials intended to approve the type of measuring tools (for medical devices which are used as measuring tools within the scope of State regulation of the assurance of uniformity of measurements), the date and number of the qualification certificate issued by the related Federal certification service;

  • for organizations responsible for clinical trials using the medical device concerned, the registration number in the list of medical organisations approved for the implementation of clinical trials for medical devices, the register of which is managed by Roszdravnadzor.

  1. Addenda to the Application shall include the following:

  • copies of contracts for all necessary test and trial services, stating (as per Application), the name and location of the manufacturer of the related medical device, the name of the medical device, including model (if applicable), or variant of implementation (if applicable), or contents of the device set/kit, and/or accessories (if applicable), quantity or number of items necessary for test or trial;

  • a copy of the document confirming the authority of the authorised representative of the manufacturer, except for legal entities or private entrepreneurs registered within the territory of the Russian Federation which are the manufacturers of the medical device while the manufacturing site is located outside the territory of the Russian Federation.

If the documents mentioned above are drawn up in a foreign language, they shall be presented with a duly certified translation into Russian.

  1. If there is a need to import into the territory of the Russian Federation some additional number or amount of medical devices necessary for tests or trials related to the medical device which has already been permitted for import, and for which the Import Permit is still valid, the Applicant shall re-submit the documents mentioned in paras. 8 and 9 of this Procedure.

  1. Within a maximum of five business days upon receiving the Application and supporting documents mentioned in para. 9 of this Procedure, Roszdravnadzor shall issue an Import Permit to the Applicant, or notify the Applicant about the rejection of their application for an Import Permit for a Medical Device, stating the reasons for such rejection.

  1. The aforementioned Import Permit for a Medical Device, or Notification of the Rejection of an Application for an Import Permit for a Medical Device, shall be entered in the Register within two business days following the related decision by Roszdravnadzor, and shall be posted in the personal area of the Applicant in SSSR as well as posted on the official website of Roszdravnadzor, within the framework of applicable restrictions as per legislation concerning commercial secrets and other sensitive information protected by law.

Within a maximum of five business days the Applicant may obtain a statement from the register on the basis of the related request.

  1. The application for an Import Permit for a Medical Device may be rejected, when:

  • the Applicant has not provided information, or provided incomplete or incorrect information, as per paras. 8 and 9 of this Procedure;

  • the import of the medical device in question into the Russian Federation is limited or restricted

in accordance with an international agreement or by a decision of the Russian Federation Government;

The single list of goods for which import or export limitations are imposed by the Member States of the Customs Union within the framework of the Eurasian Economic Community in the context of trade with third-party countries, as approved by Decision of the Board of the Eurasian Economic Commission dated 16 August, 2012, no. 134 (Official website of the Eurasian Economic Commission http://www.tsouz.ru/, 17 August, 2012, Official website of the Eurasian Economic Community http://www.eaeunion.org/, 14 December, 2018).

Articles 21 and 22 of Federal Act dated 8 December 2003, No. 164-ФЗ “On the basic principles of the state regulation of foreign trade” (Corpus of Legislation of the Russian Federation, 2003, No. 50, art. 4850; 2011, No. 50, art. 7351).

  • Roszdravnadzor has information based on the results of safety monitoring for the medical device concerned,

about side effects not stated in the instructions for use or in the operating manual of the medical device in question; or about any adverse reaction in the event of the application of the medical device in question, or about any specific interactions of medical devices, or on findings and/or circumstances which pose a threat to public well-being and to the health and safety of medical professionals in the event of the operation or application of the medical device concerned, provided the manufacturer or its authorised representative did not provide any explanation and did not specify any measures to be taken in order to prevent a possible hazard to human life and safety;

Article 96 of Federal Act dated 21 November 2011, No. 323-ФЗ “On the basic principles of public healthcare in the Russian Federation” (Corpus of Legislation of the Russian Federation, 2011, No. 48, art. 6724).

  • the Application has not been drawn up in compliance with the requirements of para.8 of this Procedure;

  • the information provided by the Applicant under paras. 8 and 9 of this Procedure does not correspond to the information obtained by Roszdravnadzor via interdepartmental communications;

  • the Application and supporting documentation are related to the import of products which are not medical devices.

  1. An Import Permit for the Medical Device could be cancelled upon the related request of the Applicant.

  1. Roszdravnadzor manages the Register in order to monitor all issued Permits and Notifications on the Rejection of an Application for an Import Permit for Medical Devices.

  1. Information regarding all issued Permits and Notifications on the Rejection of an Application for an Import Permit for Medical Devices is posted in the related Register on the official website of Roszdravnadzor hosted in the public telecommunication network Internet in compliance with all applicable restrictions imposed by existing legislation on commercial secrets and other sensitive and protected information, and contain the following details:

  • name of the service provider (Roszdravnadzor);

  • full and abbreviated (if applicable) name of the manufacturer, including brand name (if applicable), legal entity type, its registered or residential address (the latter is used in the case of a private entrepreneur);

  • tax payer identification number;

  • registration number according to the State Register of Legal Entities or Private Entrepreneurs;

  • Name of the medical device, including model (if applicable), or variant of implementation (if applicable);

  • name and address of the manufacturer (producer) of the medical device concerned;

  • address of the production (manufacturing) site of the medical device;

  • list of parts in the medical device set/kit (if applicable);

  • accessories (if applicable);

  • number of the representative samples to be imported;

  • factory code and/or serial or batch number of the imported samples;

  • date of manufacture (production) of the medical device;

  • expiry date or service life term of the medical device;

  • information regarding the date of issue and number of the MAC to be amended (if an Import Permit is required for the import of a medical device required for the implementation of amendments to the registration documents of a medical device already registered), along with the name of the medical device concerned and name of its manufacturer;

  • date and number of the Import Permit for the Medical Device issued or Notification of the Rejection of the Application for the Permit (stating the reasons for such rejection);

  • validity term of this Import Permit.

  1. The issue of an Import Permit for Medical Devices does not involve any fees or payments.

The e-version of the original text is prepared by AO Kodeks and is verified according to the Official Internet Portal of Legal Informationwww.pravo.gov.ru, as per 29.09.2020,

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