An order of the Minister of Healthcare of the Russian Federation has been published. The order implements the administrative regulation the Roszdravnadzor shall follow when issuing establishment licenses to the entities engaged in manufacturing and maintenance of medical devices (except the cases when such maintenance is being conducted by the entity for its own internal purposes). The new regulation takes effect from January 1, 2021. It is also important to mention that the administrative regulation itself has been actually adopted earlier in November 2020. 

Regulatory Background 

The present administrative regulation governs the relationships arising in the context of issuing the licenses for the entities intended to carry out such activities as manufacturing and maintenance of medical devices. Administrative regulation is a special document that sets forth the terms and sequence of the procedures to be performed in the course of the licensing process and also outlines additional aspects of the relationships and communications between the regulating authority and applicant. 

According to the regulation, an applicant could be:

  1. Legal entities or private entrepreneurs intended to or already carrying out the activity on manufacturing and technical maintenance of medical equipment (except the cases when such technical maintenance is being carried out to meet the internal needs of this legal entity or private entrepreneur), or their authorized representatives, hereinafter referred to as the applicant or licensee;
  2. Natural and legal persons seeking details on the particular license for activities on manufacturing and technical maintenance of medical equipment, or other information related to the license described herein. 

The regulating authority could provide the aforementioned information by the virtue of the following means:

  • On the official website of Roszdravnadzor,
  • On the official website of the federal state information system “Single portal of state and municipal services”,
  • In the federal state information system “Federal register of state services (functions)”,
  • On information stands in the premises of the regulating authority,
  • Via the phone consultations. 

For instance, the information to be published shall include the procedure of requesting additional information, an exhaustive list of documents to be provided by the applicant, as well as the documents the applicant may provide voluntarily at its own discretion, the eligibility criteria, timelines for the licensing process, the intended results of the review and the way they should be communicated to the applicant, forms and templates of the documents to be submitted by the applicant, description of the way the applicant may argue the decision taken by the authority, the list of the applicable laws and regulations, and also the text of the present administrative regulation. All this information should be provided for free. 

Licensing Process and Requirements in Detail 

The present administrative regulation also provides detailed information on the licensing process and the most important aspects thereof. According to the document, the licensing process should be performed by the Roszdravnadzor as the country’s regulating authority in the sphere of medical devices. The administrative regulation explicitly prohibits the Roszdravnadzor from requesting the applicant to provide any documents other than specified therein, including any additional permissions or approvals to be issued by other regulating authorities. In particular, the regulating authority may not require the applicant to prove the documents or information which:

  • Is not directly prescribed by the applicable regulations, 
  • Are being kept by the state authorities, 
  • Were not determined as missing or inappropriate during the initial refusal.

The potential results of the review include the following ones:

  1. Granting the establishment license or refusing in grating it,
  2. Re-registration or refusal in re-registration, 
  3. Provision of the information contained in the register of licenses,
  4. Suspension of the license validity term upon request of the licensee. 

The administrative regulation contains the timelines within which the state service should be provided. According to the document, the final decision would be taken by the regulating authority within 45 business days from the date the complete set of documents has been duly received by Roszdravnadzor. In case if the submission is found incomplete, the licensing process would be temporarily suspended for up to 30 calendar days within which the applicant shall restore non-compliances and submit the documents remaining. 

In order to obtain an establishment license for performing the activities on manufacturing or maintenance of medical equipment, an interested party shall provide the Roszdravnadzor with the following set of documents: 

  1. Application for the license in accordance with the appropriate form, containing the following information: full (and abbreviated – if applicable), name of the applicant, brand name, legal form of the entity, business address, including the ones where the licensing activity would take place, state registration number, and contact details; or the name and contact details of the private entrepreneur, taxpayer number, details on the licensed activity the applicant intends to carry out;
  2. Copies of the documents confirming the appropriate property rights of the applicant with regard to the premises necessary to carry out the licensed activity; 
  3. In case of an application for manufacturing medical equipment – copies of the documents confirming the property rights on the technical means and equipment necessary to carry out the manufacturing activities, a copy of the agreement between the manufacturer and applicant (if applicable), copies of documents confirming compliance with International Standard ISO 13485-2017, copies of the technical documentation for the medical equipment the applicant intends to manufacture, copies of the documents confirming the qualification and relevant experience of employees;
  4. A similar set of documents should be provided in case of applying for permission to carry out maintenance of medical equipment;
  5. The list of the documents submitted. 

According to the regulation, the Roszdravnadzor may determine to refuse in granting the license in case of failure of the applicant to submit the application in accordance with the rules set by the applicable regulations, or in case of provision of the incomplete submission. 

Additional Rules and Requirements 

Besides the aforementioned points, the administrative regulation additionally provides the rules related to the specific aspects of the licensing process. 

For instance, the regulation states that the applicant shall pay the appropriate fee for the state service addressed herein. An excerpt from the state register in the paper form could be provided for an additional fee. At the same time, an excerpt from the state register in electronic form, as well as additional information contained in the register could be provided for no fee.

According to the regulation, the regulating authority shall review the request submitted by the applicant within one business day from the date of receipt of complete submission. 

Summarizing the information provided here above, the administrative regulation provides the rules and procedures related to the establishment license an interested party shall obtain in order to be allowed to carry out the activities on manufacturing and maintenance of medical equipment. The document also contains an exhaustive list of documents the applicant shall provide to the regulating authority when applying for the license, as well as the timelines for the review and the decisions the Roszdravnadzor may take. 

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