31 March 2026

Medical Device Production Inspections in Russia: A Guide to QMS Compliance and Registration

March 31, 2026

BRACE Law Firm

Manufacturers of medical devices must ensure the quality and safety of the medical devices they produce. To achieve this, a quality management system for medical devices (the "Medical Device QMS") must be implemented.

Since January 1, 2024, the quality management system has become a subject of assessment during medical device production inspections. Without this procedure, it is currently impossible in most cases to register a medical device or amend its registration dossier.

This article details:

the definition of a medical device production inspection;
the definition of a quality management system and how to implement it;
the rules for inspecting the production of medical devices ("medical devices", "MD") in accordance with Russian legislation on the circulation of medical devices.

What Does a Medical Device Production Inspection Include?

Production inspection is an assessment of the production conditions and the quality management system of a medical device manufacturer.

The regulatory framework for inspections under the national procedure is established by the Rules for Organizing and Conducting Inspections of Medical Device Production for Compliance with Requirements for the Implementation, Maintenance, and Assessment of the Quality Management System for Medical Devices, approved by Government of the Russian Federation Decree No. 135 dated February 9, 2022 (the "Inspection Rules", "Decree No. 135").

Since January 1, 2024, production inspection has been mandatory in the following cases:

production of medical devices with risk classes 2a (sterile), 2b, and 3;

As a reminder, the risk class of an MD is the class to which devices are assigned based on the degree of potential risk associated with their use for medical purposes:

Class 1 – devices with a low degree of risk.
Class 2a – devices with a medium degree of risk.
Class 2b – devices with an increased degree of risk.
Class 3 – devices with a high degree of risk.

Each medical device may be assigned to only one class. MD classification occurs upon filing a registration application and is confirmed during subsequent pre-registration testing. The criteria for assigning a medical device to a specific class are established by Ministry of Health of Russia Order No. 4n dated June 6, 2012.[1] Classification takes into account:

the functional purpose and conditions of use of the medical device;
the duration of use;
invasiveness;
the presence of contact with or relationship to the human body;
the method of inserting the medical device into the human body (through anatomical cavities or surgically);
the use of medical devices for vital organs and systems (heart, central circulatory system, central nervous system);
the use of energy sources;
manufacturing of medical devices to individual patient orders that are subject to special requirements prescribed by medical professionals (the "medical devices manufactured to individual patient orders").

For medical devices of risk classes 1 and 2a (non-sterile), this procedure may be conducted voluntarily. However, if a production inspection has been performed, amendments to the registration dossier of such medical devices are made during the validity period of the conclusion without an expertise of safety, quality, and effectiveness.

Furthermore, according to information from Roszdravnadzor dated March 11, 2026, posted on its official website, [2] manufacturers who filed applications between January 1 and December 31, 2023, for the registration of medical devices of risk classes 2a (sterile), 2b, or 3 must confirm the implementation of a quality management system. To do this, they must undergo a primary production inspection within three years from the date of registration of such devices, following the procedure established for unscheduled inspections. Failure to do so may result in Roszdravnadzor canceling the registration of the medical device.

Cost of Medical Device Production Inspections

The manufacturer of the medical device bears the expenses associated with the production inspection.

The methodology for determining the fee is approved by Ministry of Health of Russia Order No. 91n dated February 18, 2022.[3]

The maximum fee for a production inspection during MD registration may reach 1,812,965.65 rubles, while for medical devices manufactured to individual orders subject to special requirements prescribed by medical professionals, it may reach 3,069,250.21 rubles.

Requirements for the Inspecting Organization

The list of inspecting organizations is published on the Roszdravnadzor website. Currently, the following entities may act as inspecting organizations:

FGBU "VNIIIMT" of Roszdravnadzor;
FGBU "National Quality Institute" of Roszdravnadzor.

The inspecting organization, its management, and employees involved in conducting production inspections are prohibited from:

participating in activities that may influence the independence of their judgment or their impartiality regarding the inspection results;
being developers, manufacturers, or suppliers of medical devices;
performing technical maintenance (repair) of the medical devices for which they are conducting a production assessment;
acting as authorized representatives of the developer, manufacturer, supplier, or persons performing technical maintenance (repair) of medical devices.

Roszdravnadzor has the right to send its own observers at its expense to participate in the production inspection.

The inspecting organization must also ensure the confidentiality of information constituting a commercial secret obtained during the inspection. To this end, it must document a procedure for ensuring such confidentiality, considering the possibility of engaging external experts and the participation of observers from authorized bodies. The inspecting organization and the medical device manufacturer enter into a confidentiality agreement, which must, among other things, contain provisions allowing for the submission of inspection materials to the authorized body.

The inspecting organization must maintain inspection records for at least 10 years, which must include:

information on the inspection application and reports on the results of the production inspection;
the contract for conducting the production inspection;
the justification for the duration of the production inspection;
information on monitoring the implementation of corrective actions based on inspection results;
records of complaints and subsequent corrective actions;
documents confirming the competence of inspectors and external experts;
the confidentiality agreement concluded between the inspecting organization and the medical device manufacturer.

The procedure for conducting inspections in accordance with Decree No. 135 is detailed below.

What Is Checked During an MD Production Inspection?

The subject of the inspection is the developed and implemented quality management system. A quality management system for medical devices is the organizational structure, functions, procedures, processes, and resources necessary for coordinated activities to direct and control a medical device manufacturing organization regarding quality (Paragraph 2 of Decree No. 135).

In simple terms, during a production inspection, the inspectors check how the manufacturer produces medical devices and how it controls this process to ensure their quality, safety, and effectiveness.

The Requirements for the Implementation, Maintenance, and Assessment of the Quality Management System for Medical Devices are approved by Government of the Russian Federation Decree No. 136 dated February 9, 2022 (the "QMS Requirements", "Decree No. 136").

These requirements vary depending on the risk class of the MD. Manufacturers of medical devices of risk classes 2a and 2b must implement a quality management system. For medical devices of risk class 3, as well as medical devices manufactured to individual patient orders, the quality management system must also include design and development processes.

The QMS must comply with the requirements of GOST ISO 13485-2017 "Medical devices. Quality management systems" and ensure the tracking and traceability of production procedures.

To implement a quality management system for medical devices, a manufacturer must:

develop documented requirements for risk management at all stages of the medical device life cycle;
define the processes necessary for the effective functioning of the QMS and their application by the manufacturer;
determine the sequence and interaction of processes;
determine the criteria and methods necessary to ensure effectiveness;
ensure the availability of production conditions, resources, and information necessary to support and monitor processes;
monitor, measure, and analyze processes;
take the measures necessary to achieve planned results and maintain the effectiveness of processes.

The assessment of the quality management system for medical devices is conducted regarding the following processes:

design and development, if included in the QMS;
management of documentation and records;
production and output control;
corrective and preventive actions;
customer-related processes.

All methodologies and process descriptions must be documented and maintained in an up-to-date state. Documentation may be prepared in hard copy or electronic form and must contain a description of:

requirements for the technical characteristics of the medical device and the standards to be applied, or, if such standards are not applied, the methods to be used to guarantee the quality, effectiveness, and safety of the MD;
the methods and depth of third-party control if design, production, or output control is performed by a third party;
processes for production, quality control, and quality assurance of the medical device, and measures to be used for quality control, including corrective and preventive actions;
documents for recording medical device quality indicators (internal audit reports, test results, and other documents);
means for monitoring the achievement of the required medical device quality and the functioning of the QMS;
plans, procedures, and documents for feedback from customers, including monitoring the safety and effectiveness of the medical device at the post-market stage.

The requirements for the composition of processes and documentary evidence are set forth in Decree No. 136. The composition of the documentation to be developed is also provided in Paragraph 4.2 of GOST ISO 13485-2017 and includes documents such as a quality manual, quality policy and objective statements, documented procedures, etc.

In practice, implementing a QMS is a comprehensive process that includes several stages:

a preparatory stage, during which the current state of quality management processes is analyzed, risks are assessed, and a QMS implementation plan is drafted;
development of a full package of documentation;
system implementation: personnel training, appointment of responsible persons, and organization of operations;
periodic audits performed internally or by engaging third-party organizations.

If the implemented quality management system has received a GOST ISO 13485-2017 certificate of conformity issued by an accredited certification body, the production inspection after MD registration is limited to checking compliance with requirements related to the processes of design, development, production, and output control of the medical device, as well as processes related to post-market monitoring.

Types and Procedure of Medical Device Production Inspections

Decree No. 135 provides for the following types of production inspections:

primary inspection;
periodic (planned) inspection;
unscheduled inspection.

Primary production inspections are conducted for the purposes of:

state registration of a medical device;
inclusion of a manufacturer in the register of organizations manufacturing medical devices to individual patient orders.

To conduct a primary production inspection, the medical device manufacturer or its authorized representative submits an application to the inspecting organization, specifying the medical devices and their groups listed in Annex No. 1 to Decree No. 135, and the production sites subject to inspection.

The following documents must be attached to the application in electronic form:

a certificate on the actual number of employees involved in the processes of the quality management system being assessed;
a copy of the report on the results of the most recent quality management system audit conducted by a certification body (if available).

The inspecting organization analyzes the submitted documents within 10 business days from the date the applicant submits the application. If a positive decision is made, the inspecting organization enters into a contract with the applicant to conduct the inspection. Non-compliance of the application or documents with the established requirements serves as grounds for refusing to conduct a primary inspection. The applicant is notified of the refusal and the reasons for it via registered mail or in the form of an electronic document signed with an enhanced qualified electronic signature within three business days.

The period for conducting the production inspection may not exceed 90 business days from the date the applicant submits the application. Furthermore, Decree No. 135 establishes timeframes for specific actions, including:

concluding the inspection contract (including coordination of terms, preparation, and signing of the contract) – no more than 10 business days from the date of the decision;
preparing necessary documents and traveling to the inspection site – no more than 25 business days from the date the contract is concluded;
stay at the production site – no more than 5 business days from the date of arrival.

During a primary production inspection, the implementation of the quality management system is assessed for compliance with the requirements. The inspection is conducted regarding all production sites specified in the application. The results of the production inspection for medical devices of classes 1 and 2a apply to the group of medical devices, while for medical devices of classes 2b and 3, they apply to subgroups of medical devices.

Periodic inspections are conducted once every five years from the date the primary inspection report is issued.

To conduct a periodic inspection, the applicant submits an application to the inspecting organization, specifying the medical devices and their groups (subgroups), and the production sites included in the scope of the inspection. The following documents must be attached to the application in electronic form:

a certificate on the actual number of employees involved in the processes of the quality management system being assessed;
a copy of the report on the results of the most recent production inspection;
a copy of the report on the results of the most recent quality management system audit conducted by a certification body (if available).

A periodic production inspection is conducted at production sites selected by the inspecting organization using sampled medical devices. The criteria for the inspecting organization's selection of representative medical devices include the novelty of technical solutions, purposes, production technologies, and the results of previous inspections. The justification for the selection of representative medical devices must be provided in the production inspection report.

If a periodic inspection is not passed within 90 business days from the expiration of the previous report, Roszdravnadzor will decide to cancel the state registration of the medical device..

Unscheduled production inspections are conducted for the following purposes:

amending the list of production sites or the list of medical device groups (subgroups);
confirming the remediation of violations based on production inspection results;
confirming the remediation of causes that led to the release of substandard medical devices;
confirming the manufacturer's implementation of a quality management system (if an assessment of this system for compliance with requirements was not previously conducted).

To conduct an unscheduled production inspection, the applicant also submits an application and a package of documents to the inspecting organization in electronic form:

a certificate on the actual number of employees involved in the processes of the quality management system being assessed;
information on the causes that led to the release of substandard medical devices (if applicable).

As a general rule, a production inspection is conducted with a visit by an inspection commission to the production site, defined as a geographically separate complex intended for performing the entire medical device production process or specific stages thereof.

By decision of Roszdravnadzor, assessments may be conducted using remote interaction tools (e.g., via video conferencing) in exceptional cases, such as:

the threat of, occurrence of, or response to an emergency situation and/or the threat of the spread of epidemic diseases posing a danger to others, or illnesses and injuries resulting from exposure to adverse chemical, biological, or radiation factors;
the occurrence of force majeure circumstances or circumstances beyond the control of the parties that pose a threat to the life and health of the inspectors.

Both primary and periodic inspections may be conducted remotely. To conduct an inspection using remote interaction tools, the manufacturer must provide the documents and information listed in Annex No. 7 to Decree No. 135, including a description of the QMS, technical documentation for the medical devices, and documents regulating production processes, output quality control, documentation management, etc.

Before starting an assessment conducted using remote interaction tools, the manufacturer must confirm the geolocation data (latitude, longitude) of the production site.

How Are Inspection Results Documented?

If the inspection results are positive, the inspecting organization:

prepares a report and issues it to the applicant or sends it via registered mail with acknowledgment of receipt / in the form of an electronic document signed with an enhanced qualified electronic signature;
enters a record into the Register of Conclusions, specifying the date and number of the inspection report, its validity period, the form of the inspection, the name of the medical device, the addresses of production sites, and the inspection result. The Register of Conclusions is maintained on the official Roszdravnadzor website.

A production inspection report is valid for five years from its date of issuance.

If the QMS does not meet the requirements or is not maintained in an up-to-date state, the inspecting organization may not issue a positive conclusion. The assessment of the significance of non-conformities identified during the production inspection is provided in Section III of Decree No. 135.

The classification of identified QMS non-conformities is performed in two stages:

Stage I – application of a matrix for the preliminary assessment of the significance of non-conformities;
Stage II – application of increasing points for the final assessment of the significance of non-conformities.

At Stage I, all identified non-conformities are divided into four groups depending on their significance for the safety, effectiveness, and quality of the medical device:

initially identified direct influence of a non-conformity on the safety, effectiveness, and quality of the medical device – 3 points;
initially identified indirect influence of a non-conformity on the safety, effectiveness, and quality of the medical device – 1 point;
repeatedly identified direct influence of a non-conformity on the safety, effectiveness, and quality of the medical device – 4 points;
repeatedly identified indirect influence of a non-conformity on the safety, effectiveness, and quality of the medical device – 2 points.

Multiple non-conformities with a single requirement are treated as one.

Direct non-conformities include those related to the processes of design, development, production, and output control of the medical device, while indirect non-conformities relate to requirements for the functioning of the quality management system. The term "repeatedly" means that the non-conformity was identified during one of the two most recent inspections in which the same processes were checked at the same production site.

If Stage II identifies:

the absence of documented processes for design and development, production process control, or other processes necessary to ensure safety and effectiveness;
the release into circulation of a substandard medical device;
one increasing point is assigned for each non-conformity.

A positive conclusion may not be issued if one or two violations valued at 5 or 6 points are identified, or if more than two violations valued at 4 points are identified. In such cases, a Report on the Results of the Integral Assessment of the Significance of Non-conformities is prepared, and the applicant is informed of the need for additional measures or the submission of additional materials to confirm the effectiveness of corrective actions.

Non-conformities identified during a production inspection may be remediated by the manufacturer during the inspection or no later than 30 business days after its completion.

Appealing an Inspection Conclusion

If an applicant disagrees with a negative conclusion or the identified non-conformities, it may file a claim with the inspecting organization within 30 business days from the date of receipt of the inspection report. The inspecting organization must consider the claim and send a response within 15 business days from its receipt. In the event of disagreement, the applicant may file a complaint with Roszdravnadzor or a court.

If an applicant disagrees with a decision of Roszdravnadzor, it may also appeal that decision in court. The decision is challenged according to the rules of Chapter 24 of the APC RF, Challenging Non-Normative Legal Acts, Decisions, and Actions (Omissions) of State Authorities.

To have the court grant the application, the following circumstances must be proven in aggregate:

non-compliance of the challenged decision, action (omission) with the law or another legal act;
violation of the applicant's rights and legitimate interests in the sphere of entrepreneurial or other economic activity, the illegal imposition of any duties, or the creation of other obstacles to the exercise of entrepreneurial or other economic activity.

Unfortunately, we have not found judicial practice on this issue illustrating the burden of proof.

In conclusion, the procedure for inspecting production sites is aimed at improving the quality and safety of medical devices, as it allows for the control of the production process both during registration and in the post-registration period. Undoubtedly, implementing a QMS also offers manufacturers advantages such as the optimization of production costs through the development of procedures, the reduction of operational risks, and the strengthening of counterparty trust.

However, implementing and maintaining a QMS, as well as undergoing the inspection procedure, requires significant time and financial expenditures from the manufacturer, as well as the involvement of experienced specialists.

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References

[1] Ministry of Health of Russia Order No. 4n dated June 6, 2012, On the Approval of the Nomenclature Classification of Medical Devices.

[2] See: https://roszdravnadzor.gov.ru

[3] Ministry of Health of Russia Order No. 91n dated February 18, 2022, On the Approval of the Methodology for Determining the Amount of Fees for Services Related to Inspecting the Production of Medical Devices Subject to State Registration, as well as Medical Devices Manufactured to Individual Patient Orders to Which Special Requirements for the Prescription by Medical Workers Apply, for Compliance with the Requirements for Implementation, Maintenance, and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Use.