Chapter 1 Russian Administration

1. Russian RZN

Russia's medical device regulation is mainly the responsibility of its Federal Service for Surveillance in Healthcare Roszdravnadzor (RZN), which is also known as FSSH. It is responsible for the management and supervision of the healthcare system, with specific responsibilities as follows:

• Registration management: Registration of medical devices, audit of technical documentation, clinical data, product samples, etc., to ensure that they meet safety and performance standards before being sold on the Russian market.

• Regulation development and implementation: The development and implementation of regulations and standards related to medical devices, including product design, production, labeling and market supervision, to ensure conformity with international standards and adapt to the actual situation in Russia.

• Quality control and supervision: Quality control inspection, including inspection of production facilities, supervision of production processes and market sampling of products, to ensure that medical devices on the market meet the registration requirements.

• Complaint handling and adverse event reporting: Handle complaints and adverse event reports related to medical devices, monitor problems that occur during use of medical devices, and take necessary actions such as recalling nonconforming products or modifying product manuals.

• Import and export management: Manage the import and export of medical devices, ensure that imported medical devices meet Russian standards, and monitor the compliance of exported products, including the issuance of import licenses and export certificates.

• Information and publicity: To provide information on the registration, use and regulation of medical devices, to publicize relevant policies and regulations to the public, manufacturers and medical institutions, and to publish the latest regulations and announcements through official websites and other channels.
  
  

2. Administrative Regulation

Article 38 of the Health Law (Federal Law 323)

Decree No. 1416 Medical Device Registration Rules

Ministry of Health of the Russian Federation Order No.4n

Ministry of Health of the Russian Federation Order No.11

Ministry of Health of the Russian Federation Order No. 1353n

3. Risk Level Classification

The Ministry of Health of the Russian Federation Order No.4n gives a more detailed description of the classification of medical devices. (Available by contacting Wiselink)

4、Registration Basis

Because the Russian registration is relatively independent, the Russian government does not directly recognize the registration certificate of other countries, even if the product has passed the United States FAD certification and the EU CE certification, it must go through the registration process before being allowed to enter the country.

Russia will make it mandatory for products to undergo the necessary tests in Russia, so it can be registered in Russia without any national registration history.

5. Registration Language

English.

6. Authorized Representative of Russia

Manufacturers outside Russia need to appoint a local authorized representative in Russia in order to submit a registration application, but the holder of the medical device certificate can be either the manufacturer or the local authorized representative, depending on which party is selected as the certificate holder at the time of submission of the application.

7. List of Registration Documents

① [Application form]: Usually submitted by the manufacturer or its authorized representative (such as a registered agent).

② [Product Description and Instructions for use]: Provide a detailed product description, including product functions, indications, methods of use and technical parameters. (Instructions for use in Russian are required to ensure compliance with Russian language and regulatory requirements.)

③ [Product technical documents]: Including product design and manufacturing process, material composition, quality control measures, risk management analysis, etc. These documents need to comply with Russian standards and may also be required to provide documents that comply with ISO 13485 (Quality Management System) certification. In addition, clinical trial reports are required to demonstrate the safety and efficacy of the product in specific medical conditions.

④ [Manufacturer certification]: Provide the manufacturer's legal business license, proof of compliance with the standards of production facilities and other relevant qualification documents. If the production plant is located outside Russia, certification and inspection reports from the country where the manufacturer is located are also required.

⑤ [Quality Management System certification]: Provide ISO 13485 quality management system certification, or a quality system certificate of similar standards, to prove that the manufacturer follows the quality management requirements of medical devices

⑥ [Product label and packaging ]: Provide samples of product labels to ensure that they meet the label requirements of the Russian market, including indicating the product name, manufacturer information, registration number, production date, expiration date, etc.

⑦ [Product samples]: Provide a certain number of product samples upon request for product inspection and evaluation by the Russian regulatory authorities.

⑧ [Other relevant documents]: Depending on the specific product type, other specific certification documents may be required, such as electrical safety certification, EMC (electromagnetic compatibility) test report, etc.

⑨ [Authorization document of registered agent]: If the applicant is not a local company in Russia, it is necessary to entrust a registered agent in Russia, and provide the authorization letter and registration information of the agent.

⑩ [Proof of Payment of Registration Fee]: Submit proof of payment of registration fee. The cost is usually related to the type of product, its complexity, and the level of detail of the approval process required.

⑪ [Product classification and risk assessment Report]: Submit a classification and risk assessment report of the product in accordance with the Russian medical device classification standards to determine the registration category of the product.

8. Packaging | Label Requirements:

① Russian language labels: The packaging and labels of all medical devices must be marked in Russian with product name, specification, identification code, batch number, production date, shelf life and other information.

② Manufacturer's logo: The name and address of the manufacturer must be clearly marked on the label and packaging of the medical device.

③ Instructions for use: Medical device labeling and packaging must include instructions for use, which should contain clear and detailed treatment and safety instructions.

④ Label location: Labels and barcodes must be affixed to the packaging in accordance with Russian standards.

⑤ Durability: The label on the medical device must be firm and not easy to peel or wear.

⑥ Bar code requirements: Medical devices must be affixed with a standard international commodity code bar code.

Chapter 2 Registration Flow, Official Fee & Cycle

1. Registration Flow

2. Cycle & Official Fee

Chapter 3 FAQ

Q: What is the time and cost of registering medical devices in Russia?

A: The registration cycle in Russia is longer and the cost is not low. Fees other than official fees and the actual project cycle can be obtained by contacting Wiselink.

Q: Is the official fee for medical device registration audit fixed?

A: Official fees are basically fixed, but expert audit fees may change during face-to-face meetings.

Q: Is local testing necessary for registration in Russia?

A: Yes.

Q: Is QMS on-site inspection required for medical device registration in Russia?

A: As of January 1, 2024, the Russian Federation provides for on-site QMS inspections of foreign manufacturers (applicants) for certain risk levels and categories of medical devices (IIa sterile, IIb and III). The content of inspection includes but is not limited to: quality policy, quality manual, risk management throughout the product life cycle, incoming inspection of raw materials, design and development, production, and final control related process methods, etc. Specific requirements can be referred to documents 135 and 136. On-site audits are conducted every five years. If you plan to register multiple products, consider applying for multiple product categories at once to reduce the number and cost of on-site audits.

Q: Does it require clinical trials for registration in Russia?

A: If the product submitted for registration has not been approved in Russia, the product needs to be carried out in the real world clinical trial in Russia, and the clinical trial audit will be sent to the expert committee for the second round of technical audit.

Q: What local tests are required for Russian registration?

A: We need to designate a laboratory in Russia to do the following tests:

① Local technical test;

②Local toxicology test;

③ Electrical safety and electromagnetic compatibility test (local IEC/EMC test);

④Local clinical trial;

⑤Local metrology test, if applicable.

Q: What is the cost of Russian QMS system inspection?

A: On-site inspection (factory inspection): about 60,000-80,000 yuan/factory, excluding travel.

Q: The EAEU registration is already on the calendar, how will this affect the Russian registration?

A: The unified registration regulation for medical products EAEU was officially issued on May 6, 2017, and was originally scheduled to be enforced on January 1, 2022, but after two extensions, it was finally decided that the implementation would begin on December 31, 2025, so the Russian registration (RZN) can still be submitted before December 31, 2025. As to whether there will be further delays, we need to wait for the official announcement.

Q: How long is the Russian registration certificate valid?

A: It is valid forever.

Chapter 4 Certificate Template