
Order No. 201n by the Ministry of Health of the Russian Federation
ON APPROVAL OF THE PROCEDURE FOR THE IMPORT OF MEDICAL DEVICES INTO THE TERRITORY OF THE RUSSIAN FEDERATION FOR THE PURPOSE OF STATE REGISTRATION
In accordance with Part 6 of Article 38 of the Federal Law of November 21, 2011, No. 323-ФЗ “On the basis of health protection of citizens in the Russian Federation” and subparagraph 5.2.186 of paragraph 5 of the Regulations on the Ministry of Health of the Russian Federation, approved by the Government of the Russian Federation on June 19, 2012, No. 608, it is ordered:
1. To approve the attached Procedure for the import of medical devices into the territory of the Russian Federation for the purpose of state registration.
2. To declare the order of the Ministry of Health of the Russian Federation of June 30, 2020, No. 661н “On approval of the Procedure for the import of medical devices into the territory of the Russian Federation for the purpose of state registration” (registered by the Ministry of Justice of the Russian Federation on September 28, 2020, registration No. 60070) to be null and void.
3 This Order shall come into force on September 1, 2023, and shall remain in effect until September 1, 2029.
Minister
M.A. MURASHKO
APPROVED
by the Order of the Ministry of Health
of the Russian Federation
dated May 2, 2023 No. 201н
THE PROCEDURE FOR THE IMPORT OF MEDICAL DEVICES INTO THE TERRITORY OF THE RUSSIAN FEDERATION FOR THE PURPOSE OF STATE REGISTRATION
1. This Procedure determines the rules for the import of medical devices into the territory of the Russian Federation for the purpose of state registration, including for the purpose of making changes to the documents contained in the registration dossier for a medical device, requiring technical tests, toxicological studies, clinical trials, as well as tests for the purpose of type approval of measuring instruments (in respect of medical devices related to measuring instruments in the field of state regulation of ensuring uniformity of measurements) (hereinafter referred to as amendments to registration documents).
2. The import of medical devices into the territory of the Russian Federation for the purposes of state registration, including for the purposes of making amendments to registration documents, shall be carried out by the manufacturer (producer) of the medical device, an authorized representative of the manufacturer (producer) or a person importing the medical device into the Russian Federation for the purposes of state registration (hereinafter referred to as the applicant).
3. The number of samples of a medical device imported into the territory of the Russian Federation for the purposes of state registration, including for the purposes of making amendments to registration documents, shall be determined by the applicant taking into account the recommendations of organizations performing technical tests, toxicological studies, clinical trials, as well as tests for the purposes of type approval of measuring instruments (in respect of medical devices related to measuring instruments in the field of state regulation of ensuring uniformity of measurements), depending on the class of potential risk of use of the medical device and the scope of required tests (studies).
4. Prior to the import of a medical device, the applicant sends to the Federal Service for Supervision of Healthcare (hereinafter referred to as Roszdravnadzor) using a personal account in the federal state information system “Unified Portal of State and Municipal Services (Functions)” (hereinafter referred to as the personal account on the UPSS) in the form of an electronic document signed with an enhanced qualified electronic signature or an enhanced unqualified electronic signature of the applicant, whose verification key certificate is created and used in the infrastructure ensuring information and technological interaction of information systems used for the provision of state and municipal services in electronic form, a notice of intent to import a medical device, which shall include:
1) name of the medical device with indication of model (if any), version (if any), the configuration of the medical device (if any), accessories (if any), quantity, serial number, batch or lot number (if any), date of production (manufacturing) of the medical device, expiration date (shelf life) (if any);
2) information on the date and number of the registration certificate (in case of submission of a notification for the import of a medical device in order to amend the registration documents for a previously registered medical device);
3) the intended use of the medical device as specified by the manufacturer (producer);
4) applicant information:
a) full and (if any) abbreviated name, company name (if any), legal form of the legal entity, address of its location, taxpayer identification number, main state registration number of the record on the establishment of the legal entity, telephone number and e-mail (if any);
b) surname, first name and (if any) patronymic of an individual entrepreneur, his/her residence address, data of his/her identity document, taxpayer identification number, main state registration number of the record on state registration of an individual entrepreneur, telephone number and e-mail (if any);
5) name of the manufacturer (producer) of the medical device and the address of its location, address of the place of production (manufacturing) of the medical device;
6) information on organizations in which it is planned to conduct technical tests, toxicological studies, clinical trials, as well as tests for the purpose of type approval of measuring instruments (in respect of medical devices related to measuring instruments in the field of state regulation of ensuring uniformity of measurements), indicating the date and number of the contract for conducting tests (studies).
5. If it is necessary to import into the territory of the Russian Federation an additional number of samples for tests (studies) of a medical device, the notification shall be sent repeatedly in accordance with paragraph 4 of this Procedure.
6. Within a period not exceeding one business day from the date the applicant sends the notification specified in paragraphs 4 and 5 of this Procedure, Roszdravnadzor shall notify the applicant of receipt of the notification via the personal account on the UPSS.
7. Roszdravnadzor keeps a record of accepted notifications for the import of medical devices by maintaining a register posted on Roszdravnadzor's official website in the information and telecommunications network “Internet”, subject to the restrictions established by legislation on commercial and other secrets protected by law. The registry entry contains the following information:
1) full and abbreviated (if any) names, including company name (if any), legal form of the legal entity, address of its location or place of residence (for an individual entrepreneur);
2) taxpayer identification number;
3) the main state registration number of the record on the establishment of a legal entity or individual entrepreneur;
4) name of the medical device with indication of the model (if any), version (if any);
5) name and location address of the manufacturer (producer) of the medical device;
6) address of the production (manufacturing) site of the medical device;
7) the configuration of the medical device (if applicable);
8) accessories (if any);
9) the number of samples to be imported;
10) serial number and (or) batch or lot number of the imported samples (if any);
11) date of production (manufacturing) of the medical device;
12) expiration date (shelf life) of the medical device (if any);
13) information on the date and number of the registration certificate to be amended (in case of submission of a notification for importation of a medical device in order to amend the registration documents), indicating the name of the medical device and the name of the manufacturer (producer) of the medical device;
14) date and number of the accepted notification for the import of the medical device.
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