As of January 1, 2024, a report from an authorized organization on the compliance of the quality management system (QMS) based on the results of a production site inspection became an obligatory document when applying for:

The report on the quality management system compliance is composed to ensure compliance with the requirements of GOST ISO 13485-2017. These requirements are established by the Resolution of the Russian Federation Government No. 135, dated February 9, 2022 (RF Government Resolution No. 135).

Confirmation of QMS compliance and issue of the report are based on the results of production site inspection, which means “assessment of production conditions and quality management system of the medical device manufacturer”. Based on this definition, production site inspection assesses not only production, but also other QMS processes (for example, document and record management).

The requirements for the QMS are established by the Resolution of the Russian Federation Government, dated February 9, 2022, No. 136 (RF Government Resolution No. 136).

Given that the practice of production site inspections is still in development, we prepared answers to the main questions that manufacturers and their Authorized Representatives (AR) might have.

Who should undergo production site inspection?

According to RF Government Resolution No. 135, site inspection is obligatory for:

  • manufacturers of mass-produced medical devices with risk class 2a (sterile), 2b, 3, both during registration and when amending the registration dossier;
  • manufacturers of implantable medical devices that are manufactured according by individual orders of patients, if these devices are subject to special requirements upon the appointment of medical professionals.

Manufacturers of medical devices with risk class 1 and 2a (non-sterile form) do not need to undergo production site inspection. However, if they did, they are allowed to make amendments to the registration dossier on a notification basis without examination of quality, effectiveness, and safety during the validity period of the inspection site report.

When registering a series (a batch) of medical devices and devices registered in accordance with the Decree of the Government of the Russian Federation, dated April 1, 2022, No. 552 (RF Government Decree No. 552) inspection of the production site is not required regardless of the risk class of the medical device.

When does one conduct the production site inspection?

In general, a manufacturer can undergo a production site inspection at any time. However, as stated above, it is currently impossible to submit a registration dossier for registration of a medical device without documents confirming successful completion of this inspection. Accordingly, the manufacturer and/or their AR should plan a site inspection taking into account that one should confirm the compliance of the QMS with the requirements before submitting the registration dossier to Roszdravnadzor.

Those manufacturers who submitted applications for state registration of a medical device between January 1, 2023 and December 31, 2023, and received a registration certificate (RC), have to undergo a primary site inspection within 3 years from the date of issue of the RC in the manner prescribed for unscheduled inspection.

Failure to comply with the inspection deadlines after receiving the RC may lead to suspension or cancellation of the RC. Manufacturers of implantable medical that are manufactured according by individual orders of patients (if these devices are subject to special requirements upon the appointment of medical professionals) should undergo site inspection before September 1, 2023. If the inspection was not conducted, the production of medical devices by individual orders should be suspended until one receives an inspection report with a positive conclusion.

Who conducts production site inspections?

Currently, only two state organizations subordinate to Roszdravnadzor (RZN) are authorized to conduct site inspections:

  • Federal State Budgetary Institution “VNIIIMT”;
  • Federal State Budgetary Institution “NIK”.

The legislation does not allow inspections by other certification bodies or companies. For this reason, there is a risk of an increase in the inspection duration due to the high workload of specialists from authorized organizations. We recommend that our clients apply for a site inspection at least 3-4 months before the planned date for submitting inspection results to the RZN.

What is checked during site inspection?

The scope of inspection depends on several factors: the risk class of a medical device; whether the manufacturer has a certificate of compliance of the QMS with the requirements of GOST ISO 13485-2017/ISO 13485-2016; and whether the devices are mass-produced or manufactured by individual orders from patients.

For manufacturers without the certificate of the QMS compliance who produce medical devices with risk class 3 or implantable medical devices by individual orders of patients, the scope of site inspection includes the following processes:

  • Design and development.
  • Documentation and records management.
  • Production and output inspection of medical devices.
  • Corrective and preventive actions.
  • Consumer-related processes.

Manufacturers of medical devices with risk class 2a (sterile) and 2b are exempt from control of design and development processes.

If a domestic (i.e. Russian) manufacturer has implemented the QMS according to the requirements of GOST ISO 13485-2017, and the implementation is confirmed by a certificate from a body accredited by Rosaccreditation, or if a foreign manufacturer has a certificate confirming the compliance of the QMS with the requirements of ISO 13485-2016, then site inspection controls only the following processes:

  • Design and development (for devices with risk class 3 and implantable devices manufactured by individual patient orders).

  • Production and output inspection of medical devices.

  • Consumer-related processes (concerning post-sales monitoring).

Inspection covers all sites where the controlled processes are carried out. If there are several production sites and/or locations where design, development, and other processes are carried out, all sites related to the QMS are subject to site inspection.

In what language does one submit the documents?

Production site inspection is conducted in Russian. Thus, all documents provided to the inspecting organization for preliminary examination should be in Russian. Documents in a foreign language should be provided with a translation into Russian and certified in accordance with the established procedure.

The inspection of foreign manufacturers requires the presence of an interpreter. The interpreter should ensure communication between inspectors and manufacturer representatives, as well as translate into Russian records and documents not requested for preliminary examination.

How long does it take to complete an inspection?

The total period or primary site inspection does not exceed 90 working days from the date when the applicant submits the application.

The inspection period includes the following stages:

  • 1
    10 working days from the date of submitting the application for production site inspection – analysis of submitted documents and decision on the possibility of conducting a site inspection.
  • 2

    10 working days from the date of the decision to conduct a production site inspection – making a contract to conduct a production site inspection (including the approval of contract terms, development and signing of this contract).

  • 3

    25 working days from the date of signing the contract to conduct a production site inspection – preparation of travel documents and other documents required for conducting an inspection of one or several production sites, as well as trip to the inspection site/sites.

  • 4

    5 working days from the date of arrival – stay at the production site (including the use of remote interaction tools).

  • 5

    10 working days – preparation and posting of inspection results.

If the inspector finds any nonconformities, the manufacturer has 30 working days from the date of the inspection completion to eliminate them.

The period for repeat and unscheduled inspections is similar to the period for the primary inspection.

Listed timeframes do not include the time for preparing the site for an inspection. Development and implementation of the QMS documents take (on average) from 1 to 6 months.

What is the cost of production site inspection?

Cost of an inspection is calculated according to the methodology established by the Order of the Ministry of Health of the Russian Federation, dated February 18, 2022, No. 91n (Order No. 91n).

Inspection cost directly depends on the number of working days required by the inspector(s) to conduct it. The number of working days depends on the following factors:

  • The size of inspected organization based on the actual number of employees. The larger the number, the more days the inspection will take. The minimum duration is set for organizations with up to 49 employees, the maximum duration – with more than 5,000.

  • Number of production sites. The more production sites the manufacturer has, the more time it will take to check them.

  • Distance from Moscow. If the production site is located outside Moscow, then 2 working days are added to the inspection for each production site (inspection object). In addition, one will also have to pay travel expenses for the inspectors.

According to the Order No. 91n, the maximum cost of inspection may not exceed 575,781.65 rubles (including 20% VAT). In addition to the inspection cost, one has to pay travel expenses – up to 1,237,184.00 rubles (including 20% VAT) within the territory of the Russian Federation and up to 2,493,468.56 rubles (including 20% VAT) outside the Russian Federation.

What is the assessment methodology during inspection?

For site inspection, an integrated assessment of the significance of identified nonconformities is used.

Nonconformities identified during site inspection are classified in 2 stages. During stage 1, a classification matrix serves for preliminary assessment of the degree of nonconformities significance.

In accordance with the classification matrix, the identified nonconformities are divided into 4 groups based on the quantitative values of the degree of nonconformity significance for safety, effectiveness, and quality of the medical device:

  • direct influence of nonconformity on the safety, effectiveness and quality of the medical device identified for the first time – 3 points;

  • indirect influence of nonconformity on the safety, effectiveness and quality of the medical device identified for the first time – 1 point;

  • re-identified direct influence of nonconformity on the safety, effectiveness and quality of the medical device – 4 points;

  • re-identified indirect influence of nonconformity on the safety, effectiveness and quality of the medical device – 2 points.

During stage 2, increasing points are applied to determine the final assessment of the degree of nonconformities significance. 1 point is added to the value of each nonconformity given during stage 1 in the following cases:

  • there are no documented processes which are related to the design and development of the medical device, as well as control of production processes, and are necessary to ensure the safety and effectiveness of the medical device;

  • a defective medical device has been released into circulation. However, if the manufacturer has conducted an unscheduled production site inspection to confirm elimination of the causes that led to the release of a defective device, no additional points are given.

Multiple instances of nonconformity to a single requirement are considered as one nonconformity.

The inspecting organization issues a negative conclusion based on the inspection results in the following cases:

  • one or more nonconformities are rated at 5 or 6 points;

or

  • more than 2 nonconformities are rated at 4 points.

If the identified nonconformities were corrected in the process of site inspection, such nonconformities are reflected in the report but not taken into account during an integrated assessment of nonconformities significance in the quality management system. If the manufacturer of a medical device does not correct nonconformities or violates the deadline for correcting nonconformities, within 5 working days the inspecting organization makes a corresponding entry into the register of conclusions.

The applicant has the right to challenge the negative conclusion or identified nonconformities by sending a claim within 30 working days from the date when the inspecting organization received a copy of the report on the results of the production site inspection. The inspecting organization considers the claim and sends a response within 15 working days from the date of receiving the claim.

If the agreement has not been reached, the applicant can file a complaint with the court at the location of the inspecting organization or with the authorized body.

What document is issued after site inspection?

Unlike certification bodies, which issue a certificate to confirm compliance with the QMS based on the results of audits, the inspecting organization only issues a report in the established form.

The report is sent either in paper form or as an electronic document signed with an enhanced electronic signature. In addition, information on the inspection results is posted in the register of decisions on compliance with requirements on the official website of the authorized body.

The register contains the following information:

  • unique registration number of the entry in the register of decisions;

  • date and number of the inspection report, its validity period;

  • type of inspection: primary, repeat, unscheduled;

  • purpose of inspection (for an unscheduled inspection);

  • name of the medical device;

  • class of potential application risk of the medical device;

  • group or subgroup (if any) of the medical device depending on the class of potential application risk;

  • name and location of the manufacturer company or the last name, first name and patronymic  name(if any), and place of residence of the individual entrepreneur – manufacturer of the medical device;

  • addresses of production sites;

  • inspection result.

How often is site inspection performed?

The validity period of the primary inspection report is 5 years. Therefore, one should undergo periodic (scheduled) site inspection every 5 years from the date when the primary inspection report was issued.

In addition to periodic site inspections, unscheduled inspections may be required in the following cases:

  • amendments to the list of production sites, or the list of groups (subgroups) of manufactured medical devices in accordance with the report on the inspection results;

  • confirmation of elimination of nonconformities based on the results of the previous production site inspection;

  • confirmation of elimination of the causes that led to the release of substandard medical devices;

  • confirmation of the QMS implementation by the medical devices manufacturer (if this quality management system has not been assessed for compliance with the requirements).

Can one undergo site inspection remotely?

The Decree of the Government of the Russian Federation No. 135 allows for a remote inspection with the help of remote interaction tools (video communication).

Inspection can be conducted remotely in the following cases:

  • there is a threat of occurrence, an occurrence and elimination of an emergency and (or) a threat of the spread of epidemic diseases that pose a danger to others, diseases and injuries resulting from exposure to unfavorable chemical, biological, radiation factors;

  • there have been force majeure circumstances or circumstances beyond the control of the parties that pose a threat to life and health of inspectors.

Before starting a remote assessment of the QMS, the manufacturer has to confirm the geolocation data (latitude, longitude) of the inspected production site.

How do we help with production site inspections?

The development of QMS documents, their implementation at the production site and the organization of inspections require a lot of work. Given the varying degrees of involvement of our clients, it is impossible to offer a unified set of services that would suit each client. In this regard, we have developed a number of basic options, among which the vast majority of our clients were able to choose the best one for themselves. If there is no suitable option for you among the proposed ones, we will be happy to prepare a unique set of services according to your needs.

Conclusion

Production site inspection has become an important step in receiving a registration certificate for medical devices with high classes of application risk. Preparing for and going through an inspection is a long, complex, and expensive process, especially for those manufacturers who never implemented a QMS before.

Our specialists are ready to help in developing QMS documents, implementing them and supporting a site inspection in accordance with RF Decree No. 135 and RF Decree No. 136. Our knowledge and expertise will help you prepare in the shortest possible time, minimize the risks of significant nonconformities and obtain a positive conclusion on the QMS compliance. Over the years, we have successfully developed documents and prepared production sites both for Roszdravnadzor inspections, and for audits by domestic and foreign certification bodies.

We are ready to provide you with assistance and information support on all issues related to the implementation of the QMS in accordance with GOST ISO 13585-2017/ISO 13485-2016. Contact us in any convenient way to receive a free consultation.