Order of the Ministry of Health of the Russian Federation dated February 18, 2022 No. 91n “On the approval of the methodology for determining the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use”

In accordance with clause 2 of Resolution No. 352 of the Government of the Russian Federation dated May 6, 2011 “On the approval of the list of services that should and must be submitted to the federal executive authorities, bodies of state extra-budgetary funds, and state corporations empowered, in accordance with the federal laws, to provide public services in the established sphere of activity and public services, and are provided by organizations and experts involved in the provision of public services, and determining the amount of remuneration for their provision and authorized in accordance with the laws of the Russian Federation” (Legislative Corpus of the Russian Federation, 2011, No. 20, Art. 2829), clause 10 of the Rules for arranging and conducting an inspection of the production of medical devices for compliance with the requirements for the implementation, maintenance and evaluation of the medical devices’ quality management system depending on the potential risk of their use, approved by Resolution of the Government of the Russian Federation dated February 9, 2022 No. 135 (Official web-portal with legal information (http://pravo.gov.ru), 2022, 11 February, No. 0001202202110033), I hereby order:

1. To approve:

The methodology for determining the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use as per Appendix No. 1;

The maximum amount of service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use as per Appendix No. 2.

2. This Order becomes effective from September 01, 2022, and shall be in force until September 01, 2028.

Minister

M.A. Murashko

Registered in the Ministry of Justice of the Russian Federation on February 22, 2022, Registration No. 67412

Appendix No. 1
to Order of the Ministry of Health
of the Russian Federation
dated February 18, 2022, No. 91n


The methodology for determining the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use

I. General

1. This Methodology is applied when calculating the amount of remuneration for the service of inspecting the production of medical devices subject to marketing authorisation in cases requiring an expert evaluation of quality, efficiency and safety, as well as in cases of the change in address of the manufacturing site of a medical device specified in the marketing authorisation of a medical device, except for the marketing authorisation of a series (batch) of a medical device, as well as medical devices that are manufactured according to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use (hereinafter referred to as service, production inspection, respectively).

2. The purpose of this Methodology is to determine an economically justified fee for the service provision.

II. Calculating the fee for the service

3. The fee for the service provision shall be determined for each manufacturer of a medical product or an authorized representative of a manufacturer (producer) (hereinafter referred to as the Applicant) (for each manufacturing site claimed by the Applicant) separately in accordance with the regulatory duration of production inspection and economically justified financial and labour costs.

4. Calculation of the amount of remuneration for the service provision (hereinafter referred to as the Cost) is determined by the following formula:

, where:

С is the Cost, RUB;

LI is the: Labour Intensity of works, person-days;

CE is the Cost Estimate of one day of work of one specialist of the inspecting organization directly involved in the service provision (hereinafter referred to as the Inspector) (including any compensation and incentive payments made in accordance with the legislation of the Russian Federation), RUB/person-day;

CAS is the Coefficient of the Accrual of Salaries in accordance with the legislation of the Russian Federation;

CIC is the Coefficient of Indirect Costs of the inspecting organization, which cannot be attributed directly to the costs directly related to the service provision, a percentage;

TE are the Travel Expenses directly related to the service provision, RUB.

4.1. Labour intensity of works (LI) for a primary and regular (scheduled) production inspection is determined on a case-by-case basis in accordance with the regulatory duration of production inspection, depending on the actual number of employees of the entity under inspection, provided for in Appendix No 2 to the Rules for arranging and holding an inspection of the production of medical devices for compliance with the requirements for the implementation, maintenance and evaluation of the medical devices’ quality management system depending on the potential risk of their use, approved by Resolution of the Government of the Russian Federation dated February 9, 2022 No 135 (Official web-portal with legal information (http://pravo.gov.ru), 2022, 11 February, No 0001202202110033) (hereinafter referred to as the Rules).

Labour intensity of works on an unscheduled inspection is determined on a case-by-case basis, depending on the actual labour intensity within the regulatory duration of inspection established for the primary inspection.

The regulatory duration of the production inspection includes the time spent outside the inspected organization and the time spent on analysis of the documentation and production inspection planning, as well as the time spent directly at the inspected organization and spent on the reports generated.

The regulatory duration of the production inspection depending on the actual number of employees at the entity under inspection (the manufacturing site) is given in Table 1. If the entities under the production inspection are located in another city in relation to the inspecting organization, then the regulatory duration of the production inspection is increased by 2 person-days for each entity under inspection. The regulatory duration of the production inspection is calculated for each manufacturing site in person-days based on an 8-hour working day.

Table 1.

Actual number of employees (persons) at the entity under inspection Regulatory duration of the primary production inspection, person-days Regulatory duration of the regular (scheduled) production inspection, person-days
5 – 49 6 4
50 – 99 7 5
100 – 199 8 6
200 – 499 9 7
500 – 999 10 8
1,000 – 1,999 11 9
2,000 – 4,999 12 10
More than 5,000 13 11

4.2. The medical devices’ quality management system shall be assessed during the production inspection for the processes outlined below:

– Design and development, if included in the medical device manufacturer’s quality management system;

– Documentation and records management;

– Production and output control;

– Corrective and preventive actions;

– Consumer-related ones.

When production inspections are conducted, separate actions shall be taken within the timeframes set forth in clauses 26, 29, 35 and 38 of the Rules.

4.3. The Cost Estimate of one day of work of one inspector (СE) is determined by the formula:

, where:

AMSOI is the the Average Monthly Salary of One Inspector determined on the basis of the necessary number of staff directly involved in the provision of services, taking into account the position category, in accordance with the remuneration system, as well as labour and/or collective employment agreements, RUB/person;

AS is the Average Standard of working time per month in working days, defined as the approved standard of working time per year (given a 40-hour work week), when the service is provided, divided by 12 months.

The Average Monthly Salary per inspector (AMSOI) is determined by the formula:

, where:

TP is the Total Payroll for the preceding period for the inspectors taking part in the service provision, RUB,

ANI is the Average Number of Inspectors taking part in the service provision for the previous period, persons.

4. 4. The indirect costs of the inspecting organization, which cannot be attributed directly to the costs associated with the service provision, taken into account in calculating the coefficient of indirect costs (CIC) of the inspecting organization, include:

labour costs for the administrative, management and support staff associated with the service provision, including salary accruals;

general administrative expenses, including the cost of utilities, telecommunication services, transportation services, costs associated with the purchase of inventories and property maintenance costs (hereinafter referred to as the General Administrative Expenses) related to the service provision;

cost of the depreciation of buildings, structures and other fixed assets related to the service provision.

The coefficient of indirect costs of the inspecting organization which cannot be directly referred to the costs directly associated with the service provision (CIC) is determined proportionally (on a pro rata basis) to the expenses for the remuneration of inspectors directly involved in the process of providing the service, and is calculated on the basis of the reporting data for the previous period by the formula:

, where:

LCAMS is the Labour Costs for the Administrative, Management, and Support staff associated with the service provision, including salary accruals for the reporting period, RUB;

GAE is the General Administrative Expenses associated with the provision of services for the reporting period, RUB;

CD is the Costs of the Depreciation of buildings, structures and other fixed assets related to the service provision in the reporting period, RUB;

TP is the Total Payroll for the remuneration of inspectors taking part in the service provision for the reporting period, RUB.

4.5. Travel Expenses Related directly to the service provision (TER) are determined by the formula:

, where:

Etravel is the Travel Expenses per one inspector for the service provision to the destination and back, RUB;

Eaccom is the Accommodation Expenses per one inspector during the service provision, RUB;

Epd is the per diem (daily allowance) expenses per one inspector during the period of service provision, RUB;

Eoth is Other Travel Expenses directly related to the service provision when leaving the Russian Federation (consular fee, life and health insurance for the period of travel), RUB;

Ninsp is the Number of Inspectors travelling for the purpose of the production inspection.

4.5.1. The cost of travel per one inspector for the purpose of the service provision and back (Etravel) shall be determined based on the amount of actual expenses confirmed by travel documents, but not higher than the cost of travel:

by rail: in the second class carriage of an express passenger train;

by water transport: in a V class cabin of a maritime craft of regular transport lines and all inclusive lines, in a II category cabin of a river craft of any line, in a I category cabin during a ferry crossing;

by air: in economy class;

by motor transport: in a vehicle of general use (except for cabs).

In the absence of travel documents confirming the costs incurred, the cost of travel shall be determined in the amount of the minimum fare:

by rail: in the third class carriage of a passenger train;

by water transport: in a X class cabin of a maritime craft of regular transport lines and all inclusive lines, in a III category cabin of a river craft of any line;

by motor transport: in a general type bus;

by air: in economy class.

4.5.2. The cost of accommodation per one inspector on the territory of the Russian Federation during the service provision (Eaccom) (other than in cases when an inspector on a business trip is provided with free accommodation) shall be set at the rate of actual expenses confirmed by the relevant documents, with the hotel category not exceeding the “three star” category, the hotel room category not exceeding the “first category” (standard room).

The cost of a daily allowance payment for business trips within the Russian Federation shall be determined in accordance with Resolution of the Government of the Russian Federation dated October 02, 2002 No. 729 “On the amount of compensation for expenses associated with business trips within the Russian Federation to employees who have concluded an employment contract to work in federal government bodies, employees of the state extrabudgetary funds of the Russian Federation, and the federal government agencies”1.

4.5.3. The costs associated with business trips outside the Russian Federation are defined as follows:

for a residential premises lease for business trips to the territory of foreign states for federal government civil servants, employees who have concluded an employment contract to work in federal government bodies, and employees of state extrabudgetary funds of the Russian Federation in accordance with Resolution of the Government of the Russian Federation dated August 22, 2020 No. 1267 “On establishing the limits for the reimbursement of expenses for a residential premises lease during business trips to the territory of foreign states for federal civil servants, employees who have entered into employment contracts to work in federal government bodies, employees of state extrabudgetary funds of the Russian Federation, and federal government agencies, and repealing clause 10 of the Resolution of the Government of the Russian Federation dated December 26, 2005 No. 812”2;

for the daily allowance payment in foreign currency in accordance with Resolution of the Government of the Russian Federation dated December 26, 2005 No. 812 “On the amount and procedure for the payment of a daily allowance in foreign currency and a daily allowance increment in foreign currency for business trips to the territory of foreign states for employees who have concluded an employment contract for work in federal government bodies, employees of state extrabudgetary funds of the Russian Federation, and federal government agencies”3.

4.6. The fee for the provision of services on the medical devices’ production inspection does not include expenses associated with the engagement of interpreters when inspecting production outside of the Russian Federation.

5. The fee for the provision of the services shall be reviewed no more than once a year, and no later than on December 1 of the year preceding the next fiscal year.

1 Legislative Corpus of the Russian Federation 2002, No. 40, Art. 3939; 2016, No. 12, Art. 1656.

2 Legislative Corpus of the Russian Federation 2020, No. 35, Art. 5570.

3 Legislative Corpus of the Russian Federation 2006, No. 2, Art. 187; 2020, No. 35, Art. 5570.

Appendix No. 2
to the Order of the Ministry of Health
of the Russian Federation
dated February 18, 2022 No. 91n


The maximum amount of the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use

Maximum amount of payment for the service provision, not taking into account travel expenses, RUB, incl. 20% VAT Maximum amount of travel expenses directly associated with the service provision, RUB, incl. 20% VAT (within the Russian Federation) Maximum amount of payment

for the service provision, taking into account travel expenses, RUB, incl. 20% VAT

575,781.65 1,237,184.00 1,812,965.65
Maximum amount of payment for the service provision, not taking into account travel expenses, RUB, incl. 20% VAT Maximum amount of travel expenses directly associated with the service provision, RUB, incl. 20% VAT (outside the Russian Federation) Maximum amount of payment for the service provision, taking into account travel expenses, RUB, incl. 20% VAT
575,781.65 2,493,468.56 3,069,250.21

Appendix No. 1
to the maximum amount of the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use approved by Order
of the Ministry of Health of the Russian Federation
dated February 18, 2022 No. 91n


Calculation of the maximum amount of the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use

Input data for the calculation:

Inspection of the production of medical devices subject to marketing authorisation (primary production inspection), produced outside the Russian Federation, for compliance with the requirements for the implementation, maintenance and evaluation of the medical devices’ quality management system depending on the potential risk of their use (hereinafter referred to as the Requirements), based on the actual number of employees at the entity under inspection – more than 5,000 people – by an inspection team consisting of 4 inspectors (subject to the availability of five processes included in the scope of inspection in accordance with the provisions of clause 16 of the Requirements, two of which ensure the functioning of the quality management system and can be checked by 1 inspector; the involvement of 1 inspector per process is required to check the remaining three main processes that directly affect the safety, quality and efficacy of the medical devices).

As per the Methodology for determining the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use (hereinafter referred to as the Methodology), the service cost is determined by the formula:

According to the Table 1 of the Methodology, the regulatory duration of the primary production inspection with the actual number of employees at the entity under inspection exceeding 5,000 is 13 person-days. Taking into account that the entity under the production inspection (the manufacturing site) is located in another city in relation to the inspecting organization, the regulatory duration of the production inspection is extended by 2 person-days.

The Cost Estimate of one day of work of one inspector (СE) is determined by the formula:

, where:

AMSOI is the the Average Monthly Salary of One Inspector determined on the basis of the necessary number of staff directly involved in the provision of services, taking into account the position category, in accordance with the remuneration system, as well as labour and/or collective employment agreements, RUB/person;

AS is the Average Standard of working time per month in working days, defined as the approved standard of working time per year (given a 40-hour work week), when the service is provided, divided by 12 months.

The Average Monthly Salary per inspector (AMSOI) is determined by the formula:

, where:

TP is the Total Payroll for the preceding period for the inspectors taking part in the service provision, RUB,

ANI is the Average Number of Inspectors taking part in the service provision for the previous period, persons.

RUB / person;

RUB / person-day

CAS is the Coefficient of the Accrual of Salaries of the inspectors in accordance with the legislation of the Russian Federation, eqaul to 30.2%.

The Coefficient of Indirect Costs of the inspecting organization which cannot explicitly be referred to the costs directly associated with the service provision (CIC) is determined proportionally (on a pro rata basis) to the expenses for the remuneration of inspectors directly involved in the process of providing the service, and is calculated on the basis of the reporting data by the formula:

, where:

LCAMS is the Labour Costs for the Administrative, Management, and Support staff associated with the service provision, including salary accruals for the reporting period, RUB;

GAE is the General Administrative Expenses associated with the provision of services for the reporting period, RUB;

CD is the Costs of the Depreciation of buildings, structures and other fixed assets related to the service provision in the reporting period, RUB;

TP is the Total Payroll for the remuneration of inspectors taking part in the service provision for the reporting period, RUB.

Calculation of the coefficient of indirect costs of the inspecting organization, which cannot be directly attributed to the costs directly related to the service provision, determined on the basis of accounting data for the reporting period, is shown in Table 2.

Table 2.

Item No. Abbreviation Item name Amount (RUB)
1 2 3 4
1 LCAMS: Labour Costs for the Administrative, Management, and Support staff associated with the service provision, including salary accruals for the reporting period 107,593,079.33
2 GAE: General Administrative Expenses associated with the provision of services for the reporting period 41,013,036.06
including:
2.1 communication expenses 937,124.47
2.2 cost of utilities 5,700,502.55
2.3 cost of transport services 564,957.68
2.4 property maintenance 16,057,378.01
2.5 costs for the purchase of inventories 17,753,073.35
3 CD: Cost of the Depreciation of buildings, structures and other fixed assets related to the service provision for the reporting period 70,581,929.01
4 Total indirect expenses (item 1 + item 2 + item 3) 219,188,044.40
5 TP: Total Payroll for the remuneration of inspectors engaged in the service provision for the reporting period 148,545,042.20

The coefficient of indirect costs of the inspecting organization, which cannot be directly attributed to the costs directly related to the service provision, as a percentage (item 4 / item 5) x 100 is 147.56.

The travel expenses according to the formula:

, where:

Etravel is the Travel Expenses per one inspector for the service provision to the destination and back, RUB;

Eaccom is the Accommodation Expenses per one inspector during the service provision, RUB;

Epd is the Per Diem (daily allowance) Expenses per one inspector during the period of service provision, RUB;

Eoth is Other Travel Expenses directly related to the service provision when leaving the Russian Federation (consular fee, life and health insurance for the period of travel), RUB

Ninsp is the Number of Inspectors travelling for the purpose of the production inspection.

Name of expenses Cost per unit, RUB Number of business trip days Number of inspectors, persons
Daily allowance (outside the Russian Federation) 5,483.95 5 4
Air and train tickets (round trip), (outside the Russian Federation) 459,571.00 4
Accommodation 24,373.12 5 4
Consular fee 12,186.56 4
Insurance for the period of stay outside the Russian Federation 1,274.23 4
Cost of roaming communication services 350.00 5 4

where:

LI = 15 person-days: labour intensity of works on the assessment of the compliance of the production conditions and quality management system of a medical product’s manufacturer (production inspection) with the Requirements;

СE = 11,516.37 RUB/person-day is the Cost Estimate for one day of work per one inspector;

CAS = 30.2% is the Coefficient of the Accrual of Salaries in accordance with the legislation of the Russian Federation;

CIC = 147.56 is the Coefficient of Indirect Costs of the organization, which cannot be attributed directly to the costs directly related to the service provision.

TER = 2,493,468.56 RUB is the Travel Expenses Related directly to the service provision outside the Russian Federation.

Appendix No. 2
to the maximum amount of service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use approved by Order
of the Ministry of Health of the Russian Federation
dated February 18, 2022 No. 91n


Calculation of the maximum amount of the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use

Input data for the calculation:

Inspection of the production of medical devices subject to marketing authorisation (primary production inspection), produced in the Russian Federation, for compliance with the requirements for the implementation, maintenance and evaluation of the medical devices’ quality management system depending on the potential risk of their use (hereinafter referred to as the Requirements), based on the actual number of employees at the entity under inspection – more than 5,000 people – by an inspection team consisting of 4 inspectors (subject to the availability of five processes included in the scope of the inspection in accordance with clause 16 of the Requirements, two of which ensure the functioning of the quality management system and can be checked by 1 inspector; the involvement of 1 inspector per process is required to check the remaining three main processes that directly affect the safety, quality and efficacy of the medical devices).

As per the Methodology for determining the service fee for the inspection of the production of medical devices subject to marketing authorisation, as well as medical devices made to individual orders of patients subject to special requirements for their prescription by healthcare professionals, for compliance with the implementation, maintenance and evaluation of the medical devices’ quality management system, depending on the potential risk of their use (hereinafter referred to as the Methodology), the service cost is determined by the formula:

According to the Table 1 of the Methodology, the regulatory duration of the primary production inspection with the actual number of employees at the entity under inspection exceeding 5,000 is 13 person-days. Taking into account that the entity under the production inspection (the manufacturing site) is located in another city in relation to the inspecting organization, the regulatory duration of the production inspection is extended by 2 person-days.

The Cost Estimate of one day of work of one inspector (СE) is determined by the formula:

, where:

AMSOI is the the Average Monthly Salary of One Inspector determined on the basis of the necessary number of staff directly involved in the provision of services, taking into account the position category, in accordance with the remuneration system, as well as labour and/or collective employment agreements, RUB/person;

AS is the Average Standard of working time per month in working days, defined as the approved standard of working time per year (given a 40-hour work week), when the service is provided, divided by 12 months.

The Average Monthly Salary per inspector (AMSOI) is determined by the formula:

, where:

TP is the Total Payroll for the preceding period for the inspectors taking part in the service provision, RUB,

ANI is the Average Number of Inspectors taking part in the service provision for the previous period, persons.

RUB / person;

RUB / person-day.

CAS is the Coefficient of the Accrual of Salaries of the inspectors in accordance with the legislation of the Russian Federation, eqaul to 30.2%.

The coefficient of indirect costs of the inspecting organization which cannot be directly referred to the costs directly associated with the service provision (CIC) is determined proportionally (on a pro rata basis) to the expenses for the remuneration of inspectors directly involved in the process of providing the service, and is calculated on the basis of the reporting data for the previous period by the formula:

, where:

LCAMS is the Labour Costs for the Administrative, Management, and Support staff associated with the service provision, including salary accruals for the reporting period, RUB;

GAE is the General Administrative Expenses associated with the provision of services for the reporting period, RUB;

CD is the Costs of the Depreciation of buildings, structures and other fixed assets related to the service provision in the reporting period, RUB;

TP is the Total Payroll for the remuneration of inspectors taking part in the service provision for the reporting period, RUB.

Calculation of the coefficient of indirect costs of the inspecting organisation, which cannot be directly attributed to the costs directly related to the service provision, determined on the basis of accounting data for the reporting period, is shown in Table 3.

Table 3.

Item No. Abbreviation Item name Amount (RUB)
1 2 3 4
1 LCAMS Labour Costs for the Administrative, Management, and Support staff associated with the service provision, including salary accruals for the reporting period 107,593,079.33
2 GAE General Administrative Expenses associated with the provision of services for the reporting period 41,013,036.06
including:
2.1 communication expenses 937,124.47
2.2 cost of utilities 5,700,502.55
2.3 cost of transport services 564,957.68
2.4 property maintenance 16,057,378.01
2.5 costs for the purchase of inventories 17,753,073.35
3 CD Cost of the Depreciation of buildings, structures and other fixed assets related to the service provision for the reporting period 70,581,929.01
4 Total indirect expenses (item 1 + item 2 + item 3) 219,188,044.40
5 TP Total Payroll for the remuneration of inspectors engaged in the service provision for the reporting period 148,545,042.20

The coefficient of indirect costs of the inspecting organization, which cannot be directly attributed to the costs directly related to the service provision, as a percentage (item 4 / item 5) x 100 is 147.56.

The travel expenses according to the formula:

, where:

Etravel is the Travel Expenses per one inspector for the service provision to the destination and back, RUB;

Eaccom is the Accommodation Expenses per one inspector during the service provision, RUB;

Epd is the Per Diem (daily allowance) Expenses per one inspector during the period of the service provision, RUB;

Ninsp is the Number of Inspectors travelling for the purpose of the production inspection.

Name of expenses Cost per unit, RUB Number of business trip days Number of inspectors, persons
Daily allowance (within the Russian Federation) 700.00 5 4
Air and train tickets (round trip), within the Russian Federation 266,796.00 4
Accommodation 7,800.00 5 4

where:

LI = 15 person-days: labour intensity of works on the assessment of the compliance of the production conditions and quality management system of a medical product’s manufacturer (production inspection) with the Requirements;

СE = 11,516.37 RUB/person-day is the Cost Estimate for one day of work per one inspector;

CAS = 30.2% is the Coefficient of the Accrual of Salaries in accordance with the legislation of the Russian Federation;

CIC = 147.56 is the Coefficient of Indirect Costs of the organization which cannot be attributed directly to the costs directly related to the service provision;

TE = 1,237,184.00 RUB is the Travel Expenses directly related to the service provision within the Russian Federation.