PUBLIC OFFER
for the Provision of Medical Device Registration Services
MicroLife LLC
Moscow
Publication Date: 01.02.2026
1. Terms and Definitions
1.1. Customer — an individual (including individual entrepreneurs) or a legal entity that has accepted this Offer and is the manufacturer of the medical device or an authorized representative thereof.
1.2. Contractor — MicroLife Limited Liability Company (MicroLife LLC), Taxpayer Identification Number (INN): 9710093091, Registration Reason Code (KPP): 771001001, Legal address: Russian Federation, Moscow, intramunicipal territory Presnensky Municipal District, Kozikhinsky Bolshoy Lane, building 22, structure 1, premises I, room 9.
1.3. Services — a set of actions related to the preparation of documents, interaction with the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and expert organizations for the purpose of obtaining a registration certificate for a medical device, as well as services related to technical regulation, certification, and declaration of conformity.
1.4. Offer — this document, published on the Contractor's official website on the Internet at: https://www.macro-life.ru/.
2. Subject of the Offer
2.1. The Contractor undertakes, upon the Customer's instruction, to provide services for the registration of medical devices and/or support for procedures related to the circulation of medical devices on the territory of the Russian Federation / Eurasian Economic Union (EAEU), and the Customer undertakes to pay for these services.
2.2. The name, scope, cost of services, and terms of provision are agreed upon by the Parties in a Commercial Proposal or Specification, which become an integral part of this Agreement from the moment they are signed by the Parties or from the moment the Customer performs conclusive actions to pay the advance/prepayment.
3. Procedure for Concluding the Agreement
3.1. The text of this Offer constitutes an official invitation by the Contractor to enter into an Agreement on the terms specified herein.
3.2. The Agreement is deemed concluded and comes into force from the moment funds are credited to the Contractor's settlement account as payment for the Services (acceptance of the Offer) or from the moment the Parties sign the Specification (Application/Order).
3.3. By accepting this Offer, the Customer confirms their legal capacity and legal right to register the medical device.
4. Obligations of the Parties
4.1. The Contractor undertakes to:
4.1.1. Provide Services in accordance with the Terms of Reference (Specification) and the requirements of the legislation of the Russian Federation (Government Decree No. 1416, Decision of the Council of the Eurasian Economic Commission No. 130, etc.).
4.1.2. Advise the Customer on matters related to the preparation of the necessary package of documents (technical, operational, and clinical documentation).
4.1.3. Carry out legally significant actions: submission of applications, interaction with expert institutions, receipt and delivery of registration documents to the Customer.
4.1.4. Ensure the confidentiality of information received from the Customer.
4.2. The Customer undertakes to:
4.2.1. Provide the Contractor, in a timely manner, with complete and accurate information, documents, and product samples necessary for the provision of the Services.
4.2.2. Pay for the Services in the manner and within the timeframes stipulated in the Specification.
4.2.3. Appoint authorized representatives to interact with experts.
4.2.4. Not transfer the obtained registration certificate to third parties without the consent of the Contractor, unless otherwise provided by law.
5. Cost of Services and Payment Procedure
5.1. The cost of services is determined in the Specification and includes the Contractor's fee, and may also include reimbursement of expenses (state duties, expert fees), if separately agreed upon.
5.2. Payment is made by bank transfer to the Contractor's settlement account based on the issued invoice.
6. Procedure for Acceptance and Transfer of Services
6.1. The result of the rendered service is:
* obtaining a registration certificate from Roszdravnadzor for the medical device;
* or obtaining a notification of amendments to the dossier;
* or a Certificate of Acceptance of Services Rendered signed by the Parties.
7. Liability of the Parties and Dispute Resolution
7.1. For non-fulfillment or improper fulfillment of obligations, the Parties shall be liable in accordance with the legislation of the Russian Federation.
7.2. The Contractor shall not be liable for refusal of registration by Roszdravnadzor if such refusal is caused by the inaccuracy of documents provided by the Customer or by changes in legislation.
7.3. All disputes shall be resolved through negotiations, and if agreement is not reached, in court at the location of the Contractor.
PERSONAL DATA PROCESSING POLICY
MicroLife LLC
1. General Provisions
1.1. This Personal Data Processing Policy (hereinafter referred to as the "Policy") has been developed in accordance with Federal Law No. 152-FZ of 27 July 2006 "On Personal Data" (hereinafter referred to as FL-152).
1.2. This Policy defines the procedure for processing personal data and measures to ensure their security at MicroLife LLC (hereinafter referred to as the "Operator") in order to protect the rights and freedoms of individuals and citizens.
1.3. This Policy applies to all personal data that the Operator receives from:
* Customers of medical device registration services (clients);
* Representatives of medical device manufacturers;
* Visitors to the website https://www.macro-life.ru/;
* Counterparties and suppliers.
2. Purposes of Personal Data Collection
The Operator collects and processes personal data solely for the following purposes:
2.1. Conclusion and performance of contracts (offers): Identification of a party within the framework of civil law relations.
2.2. Medical device registration: Preparation of documents for submission to Roszdravnadzor, where specifying the details of the manufacturer's representatives is required.
2.3. Communication with the client: Consulting on registration issues, responding to inquiries, sending notifications about the status of an application.
2.4. Promotion of services on the market: Sending information letters and commercial proposals (subject to separate consent).
2.5. Website performance analysis: Collection of anonymised statistics (using cookies) to improve the website's functionality.
3. Legal Grounds for Processing
3.1. The Constitution of the Russian Federation and the Civil Code of the Russian Federation.
3.2. Federal Law No. 152-FZ "On Personal Data".
3.3. Contracts concluded between the Operator and the personal data subject.
3.4. Consent to the processing of personal data (in cases where processing is not necessary for the performance of a contract).
4. Scope and Categories of Data Processed
4.1. The Operator processes the following categories of personal data:
* Identifiable information: Last name, first name, patronymic (if applicable).
* Contact information: Telephone number, email address.
* Professional information: Place of work, job title.
* Financial data (for Legal Entities and Individual Entrepreneurs only): Taxpayer Identification Number (INN), bank details necessary for settlements.
* Technical data: IP address, information from cookies, browser data (when visiting the website).
Important note: MicroLife LLC does not process special categories of personal data concerning health, unless expressly required within the registration procedure for a specific product and only with written consent.
5. Procedure and Conditions of Processing
5.1. The processing of personal data is carried out using and without the use of automation tools.
5.2. The Operator ensures the recording, systematisation, accumulation, and storage of personal data of Russian citizens using databases located on the territory of the Russian Federation.
5.3. Processing periods: Personal data is processed until the purposes of processing are achieved, or until the subject withdraws their consent, or until the Operator is liquidated.
5.4. Cross-border transfer: The Operator may carry out cross-border data transfer only when working with foreign manufacturers of medical products (for example, requests to authorised bodies of EAEU countries, Switzerland, or China) and only to the extent necessary for the performance of the contract, in compliance with the requirements of Article 12 of FL-152.
6. Protection of Personal Data
6.1. The Operator appoints a person responsible for organising the processing of personal data.
6.2. The Operator takes the necessary legal, organisational, and technical measures to protect personal data from unauthorised or accidental access, destruction, modification, blocking, copying, provision, distribution, as well as from other unlawful actions.
7.
7.1. The personal data subject has the right to:
* receive information concerning the processing of their personal data;
* demand the rectification, blocking, or destruction of personal data if they are incomplete, outdated, or unlawfully obtained;
* withdraw consent to the processing of personal data;
* appeal the actions of the Operator to the authorised body (Roskomnadzor).
8. Final Provisions
8.1. This Policy is a public document and is subject to publication on the Operator's official website.
8.2. The Operator has the right to make changes to this Policy. The new version of the Policy comes into force from the moment it is posted on the Website, unless otherwise provided by the new version.
Contact information for sending inquiries and withdrawing consents:
Legal address: Russian Federation, Moscow, intramunicipal territory Presnensky Municipal District, Kozikhinsky Bolshoy Lane, building 22, structure 1, premises I, room 9.
E-mail: https://www.macro-life.ru/
