Registration of medical devices

1. Registration application:
Completed application form for state registration of a medical device.
2. Manufacturer documents:
Certificate of state registration of the manufacturer (for foreign manufacturers — an equivalent document, legalized and translated into Russian).
Confirmation of the authority of the manufacturer’s representative in Russia (if registration is handled by a Russian representative).
3. Technical documentation for the medical device:
Device description: technical specifications, intended use, methods of application.
User manual: instructions for use, maintenance, and repair.
Device classification: indication of the risk class (classes I, IIa, IIb, III).
4. Declaration of conformity or certificate of conformity:
Confirmation of compliance with the requirements of the Customs Union Technical Regulations (TR CU), if applicable.
5. Clinical and preclinical testing:
Reports on preclinical studies: data on the biological safety of the device.
Reports on clinical trials: data on the effectiveness and safety of the medical device obtained from clinical studies.
6. Safety confirmation documents:
Certificates or declarations of compliance with safety standards, including electrical and mechanical safety, electromagnetic compatibility.
7. Documents on materials used in the device:
Description of the chemical composition of materials that come into contact with the human body (if applicable).
8. Quality management system documents:
ISO 13485 certificates (international standard for quality management systems in medical device manufacturing).
9. Photographs or drawings of the medical device:
Detailed images of the device, its components, and packaging.
10. Medical device labeling:
Sample labeling of the device and its packaging in Russian.
11. Software documentation (if applicable):
If the device includes embedded software, documents describing its functions and safety must be provided.
12. Service contract (if required):
Documents confirming the availability of service support for the device in the Russian Federation (if necessary).
13. Import documents for the medical device:
Customs documents for importing the device into Russia (if the device is imported).
14. Payment documents for the state duty:
Receipt of payment of the state duty for registration.

This list may vary depending on the type of medical device and its risk class. Before starting the registration process, it is recommended to consult with experts in this field or contact regulatory authorities.

Medical devices are classified based on the degree of risk they pose to the patient. The classification takes into account their intended use, duration of contact with the body, and the potential to cause harm to health. In Russia and the EAEU (Eurasian Economic Union) countries, medical devices are classified into four risk classes:

Class 1: Low risk
Medical devices that do not pose a significant risk to the patient and do not require complex control during use.
Examples:

-Bandages, plasters.
-Thermometers.
-Surgical gloves.
-Walkers, wheelchairs without active elements.

Class 2a: Medium risk
Devices that have a moderate level of risk and may interact with the patient's body for a limited time. They require monitoring for safety and effectiveness but do not require constant supervision.
Examples:

-Diagnostic devices (ultrasound, ECG).
-Suture materials.
-Contact lenses.
-Infusion systems.

Class 2b: Increased risk
Devices that pose a higher level of risk to the patient's health and require careful monitoring during use. These devices may have prolonged contact with the patient's body or control vital functions.
Examples:

-Ventilators (mechanical ventilation devices).
-Insulin pumps.
-External pacemakers.
-Joint prostheses.

Class 3: High risk
Devices that pose the greatest risk to the patient's health, are typically implanted in the body, and may affect vital functions or have long-term contact with the body. These devices require particularly rigorous control and clinical testing.
Examples:

-Implantable pacemakers.
-Vascular stents.
-Neurostimulators.
-Intraocular lenses.

Registration certificates issued before 1 January 2013:
Are of indefinite duration. That is, such certificates are valid for the entire time of use of the product, if no changes are made to the design or purpose of the product.
Registration certificates issued after 1 January 2013:
Also are indefinite, if the product is not subject to change or cancellation of registration certificate by decision of the supervisory authority (eg Roszdrava) in case of detection of discrepancies in safety or efficiency.
Possible exceptions:
If a significant change is made to the design of the product, its functionality or purpose, re-registration may be required.
The registration conditions may be revised in case of changes to legislation or requirements for medical products.

The toxicological tests should confirm the safety of materials used in a medical product when interacting with the human body. It is important that the tests are conducted in accredited laboratories and comply with Russian standards and norms.

1. Official website of the Russian Federation
The Roszdravrovo provides access to a database of registered medical products. For authentication, you need:
- Go to the official website of Roszdravnadzor.gov.ru (https://roszdravnadzor.gov.ru).
- Go to "Registers".
- Select "Register of registered medical products".
- Enter the registration certificate number or the name of the product/manufacturer.
- The system will show the registration data of the medical device if it is actually registered.
2. Use of the Unified Health Information System (USIS)
There is an integrated information system for monitoring and supervising the handling of medical products. The registration certificates can also be checked in this system:
- Go to the EISS portal.
- Find the section related to medical products and their registration.
- Enter product registration data for search.
3. Request to Roszdravnosor
If for any reason the information on the site is unavailable or doubtful, you can send an official request to the Russian Federation for confirmation of the registration certificate. This requires:
Prepare a written request indicating the registration certificate number, data on the medical product and manufacturer.
Send the request to the territorial office of the Russian Surveillance at the place of registration or by electronic communication channels.

The Medical Device Registry usually contains the following information:

Medical product name.
Manufacturer.
Country of origin.
Registration certificate number.
Date of registration.
Validity of registration certificate.
Classification of medical products by risk.
Purpose of the medical product.
Specifications.
Results of tests conducted.
Other information required to assess the safety and efficacy of a medical product.

Usually, to search for information about a medical product in the registry, it is sufficient to enter its name, registration certificate number or other known data. Search results provide detailed information about the specific product.

Key factors to consider when choosing a company:

1. Competence of employees
- Professional team: It is important that the company has experts in various fields: engineers, lawyers, certification specialists, and clinical trial experts.
- Licenses and certifications: Ensure that the company’s employees have the necessary certificates and licenses to carry out registration support tasks.
2. Range of services
- Full range of services: A good company should offer all necessary services: documentation preparation, testing, organization of clinical trials, quality certification (e.g., ISO 13485), and interaction with Roszdravnadzor.
- Post-registration support: Some companies offer support even after obtaining the registration certificate, which can be helpful in case of changes in legislation or product requirements.
3. Knowledge of legislation and regulatory requirements
- Up-to-date knowledge: Registration of medical devices requires strict compliance with norms and standards that are constantly updated. Ensure the company is aware of the latest changes in legislation and regulatory acts.
- Experience with different classes of medical devices: Depending on the risk class of your product, the company should be able to correctly classify the device and consider all regulatory requirements for that class.
4. Connections and interaction with regulators
- Relationships with Roszdravnadzor and testing laboratories: A company with experience interacting with Roszdravnadzor and accredited testing laboratories will be able to resolve issues more quickly during testing and registration.
- Accreditation of testing centers: Check which laboratories the company works with and whether they are accredited to conduct the necessary tests.
5. Transparency and accountability
- Clear contract terms: All terms and stages of work should be clearly outlined in the contract: deadlines, cost of services, and guarantees.
- Accountability for results: Ensure the company is willing to take responsibility for meeting deadlines and the final outcome of the registration process.
6. Cost of services
- Transparent estimate: The cost of services should be justified and transparent, with no hidden fees. Note that a low price does not always guarantee high-quality services, and inflated rates are not always a sign of professionalism.
- Value for money: Compare offers from several companies to find the best balance of price and quality of services.
7. Case studies and recommendations
- Client recommendations: Request references from other clients or partners the company has worked with. Experienced companies often have successful case studies and are willing to provide them.
- Case studies in your industry: If the company has worked with medical devices similar to yours, this increases the chances of successful registration.
8. Localization and market knowledge
- Local offices: It is preferable for the company to have offices or representatives in the country where the registration will take place, as this will facilitate interaction with local regulators.
- Market knowledge: The company should understand the specifics of the medical device market in your country and be aware of all regulatory requirements.
9. Personalized approach
- Dedicated project manager: Good companies assign a project manager who will oversee the registration process and promptly address any issues that arise.
- Flexibility in solving tasks: Ensure the company is ready to adapt its services to your needs and work with the unique requirements of your device.

Key stages of registration and their duration:

1. Preparation of documents:
- Collection and preparation of all necessary documents (technical documentation, testing, clinical studies, etc.) can take 1 to 3 months, depending on the complexity of the device and the availability of all initial data.

2. Submission of documents to Roszdravnadzor:
- Checking the completeness and accuracy of the submitted documents takes about 1 month. If errors or incomplete information are found, the process may be delayed due to the need for corrections.

3. Safety and quality assessment:
- Preclinical and clinical testing of the device can take 3 to 6 months if they have not yet been conducted. For complex medical devices, especially implantable or high-risk ones, the testing period may be longer.

4. Certification process according to standards:
- If the device requires confirmation of compliance with safety standards (e.g., ISO 13485), the certification process can take 1–3 months.

5. Roszdravnadzor assessment:
- After completing the testing, Roszdravnadzor conducts an assessment of the documents and test results. This stage can take up to 50 working days (approximately 2.5 months). For complex devices or deficiencies in the documentation, the process may be extended.

6. Issuance of the registration certificate:
- After successful completion of all assessments and checks, Roszdravnadzor makes a decision on registration and issues a registration certificate. This can take up to 30 working days (approximately 1.5 months).

Factors influencing the duration of the process:
- Device risk class: High-risk devices (classes 2b and 3) require longer and more thorough checks, which increases the registration time.
- Documentation readiness: If all documents are collected correctly and meet the requirements, the process can proceed faster.
- Availability of clinical trials: If trials have already been conducted, the process will be faster. If clinical trials are still pending, this may take several months.
- Documentation adjustments: If errors or inconsistencies are identified during the document review, additional time will be required to correct them.