04/01/2023 | EAEU Decisions
Order of the Ministry of Health of the Russian Federation
of July 21, 2020 No. 726n
"On Approval of the Methodology for Determining the Fee for the Service of Assessing the Manufacturing Conditions and Quality Management System of a Medical Device Manufacturer (Manufacturing Inspection) for Compliance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Application for the Purpose of Registration of Medical Devices within the Eurasian Economic Union, and the Maximum Fee for Such Service"
(Registered with the Ministry of Justice of Russia on 11.12.2020 No. 61425)
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ORDER
of 21 July 2020 No. 726n
ON APPROVAL OF THE METHODOLOGY
FOR DETERMINING THE FEE FOR THE SERVICE OF ASSESSING
THE MANUFACTURING CONDITIONS AND QUALITY MANAGEMENT SYSTEM
OF A MEDICAL DEVICE MANUFACTURER (MANUFACTURING INSPECTION)
FOR COMPLIANCE WITH THE REQUIREMENTS FOR THE IMPLEMENTATION,
MAINTENANCE AND ASSESSMENT OF THE QUALITY MANAGEMENT SYSTEM
FOR MEDICAL DEVICES DEPENDING ON THE POTENTIAL RISK
OF THEIR APPLICATION FOR THE PURPOSE OF REGISTRATION
OF MEDICAL DEVICES WITHIN THE EURASIAN ECONOMIC UNION,
AND THE MAXIMUM FEE FOR SUCH SERVICE
In accordance with paragraph 2 of Resolution of the Government of the Russian Federation of 6 May 2011 No. 352 "On Approval of the List of Services that are Necessary and Mandatory for the Provision of Public Services by Federal Executive Authorities and the State Atomic Energy Corporation Rosatom, and are Provided by Organisations Participating in the Provision of Public Services, and on Determining the Fee for Such Services" (Collection of Legislation of the Russian Federation, 2011, No. 20, Art. 2829; 2020, No. 1, Art. 51), I hereby order:
To approve:
the methodology for determining the fee for the service of assessing the manufacturing conditions and quality management system of a medical device manufacturer (manufacturing inspection) for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their application for the purpose of registration of medical devices within the Eurasian Economic Union, pursuant to Annex No. 1;
the maximum fee for the service of assessing the manufacturing conditions and quality management system of a medical device manufacturer (manufacturing inspection) for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their application for the purpose of registration of medical devices within the Eurasian Economic Union, pursuant to Annex No. 2.
Minister
M.A. MURASHKO
Annex No. 1
to Order of the Ministry of Health
of the Russian Federation
of 21 July 2020 No. 726n
METHODOLOGY
FOR DETERMINING THE FEE FOR THE SERVICE OF ASSESSING
THE MANUFACTURING CONDITIONS AND QUALITY MANAGEMENT SYSTEM
OF A MEDICAL DEVICE MANUFACTURER (MANUFACTURING INSPECTION)
FOR COMPLIANCE WITH THE REQUIREMENTS FOR THE IMPLEMENTATION,
MAINTENANCE AND ASSESSMENT OF THE QUALITY MANAGEMENT SYSTEM
FOR MEDICAL DEVICES DEPENDING ON THE POTENTIAL RISK
OF THEIR APPLICATION FOR THE PURPOSE OF REGISTRATION
OF MEDICAL DEVICES WITHIN THE EURASIAN ECONOMIC UNION
1. This Methodology has been developed in accordance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Application, approved by Decision of the Council of the Eurasian Economic Commission of 10 November 2017 No. 106 (Official website of the Eurasian Economic Union http://www.eaeunion.org/, 5 March 2018, hereinafter — the Requirements), and establishes the procedure for calculating the fee for the service of assessing the manufacturing conditions and quality management system of a medical device manufacturer (manufacturing inspection) for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their application for the purpose of registration of medical devices within the Eurasian Economic Union (hereinafter — the service and manufacturing inspection respectively).
3. The purpose of this Methodology is to determine an economically justified fee for the provision of the service.
4. The fee for the service shall be determined for each applicant (for each manufacturing site declared by the manufacturer) separately, in accordance with the standard duration of the manufacturing inspection and economically justified material and labour costs.
5. The fee for the service (hereinafter — the cost) shall be calculated using the following formula:
C = t × Ce × (1 + (Kpay + Kind) / 100) + VAT + Ctr, where:
C — cost, RUB;
t — labour intensity of work, person-days;
Ce — cost estimate per one working day of one specialist of the inspecting organisation directly involved in the provision of the service (hereinafter — inspector) (inclusive of all compensation and incentive payments made in accordance with the legislation of the Russian Federation), RUB/person/day;
Kpay — payroll contribution rate in accordance with the legislation of the Russian Federation;
Kind — indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service, as a percentage;
Ctr — travel expenses directly related to the provision of the service, RUB.
The fee for the periodic (scheduled) and unscheduled manufacturing inspection service does not include the cost of sampling and testing of medical devices (implantable, invasive, and in vitro diagnostic medical devices) of potential risk class 3.
5.1. The labour intensity (t) for initial and periodic (scheduled) manufacturing inspection shall be determined on a case-by-case basis in accordance with the standard duration of the manufacturing inspection depending on the actual number of employees at the inspection site, as provided for in paragraph 4 of Annex No. 1 to the Requirements.
The labour intensity for unscheduled inspection shall be determined on a case-by-case basis depending on the actual labour intensity within the standard duration established for the initial inspection.
The standard duration of a manufacturing inspection includes the time spent outside the inspected organisation on document review and inspection planning, as well as the time spent directly at the inspected organisation on report preparation.
The standard duration of a manufacturing inspection depending on the actual number of employees at the inspection site (manufacturing site) is set out in Table 1. If the manufacturing inspection sites are located in a different city from the inspecting organisation, the standard duration of the manufacturing inspection shall be increased by 2 person-days for each inspection site. The standard duration of the manufacturing inspection shall be calculated for each manufacturing site in person-days based on an 8-hour working day.
Table 1
| Actual number of employees (persons) at the inspection site | Standard duration of initial manufacturing inspection, person-days | Standard duration of periodic (scheduled) manufacturing 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 |
| over 5,000 | 13 | 11 |
5.2. During the manufacturing inspection, the quality management system for medical devices shall be assessed with respect to the following processes:
— design and development processes, if included in the manufacturer's quality management system;
— document and record management processes;
— manufacturing and output control processes;
— corrective and preventive action processes;
— customer-related processes.
The manufacturing inspection shall include the activities listed in Table 2.
Table 2
Standard Names and Labour Intensity Norms for Activities
Performed in the Course of Providing the Service
| Name of activity | Labour intensity norm, person-days | Number of inspectors participating in the inspection stage |
|---|---|---|
| Preparation for Manufacturing Inspection | ||
| 1. Conclusion of a contract with the medical device manufacturer based on the results of: — review of the inspection request submitted by the applicant; — document review; — identification of manufacturing sites to be subject to inspection; — determination of the terms of the manufacturing inspection contract to be concluded with the applicant; — determination of the need to engage interpreters or simultaneous interpreters (the number of interpreters or simultaneous interpreters required for the service shall be determined by the documentary procedures of the inspecting organisations). 2. Planning the manufacturing inspection (selection of the inspection team and team leader). 3. Distribution of duties and responsibilities among inspection team members during the manufacturing inspection (taking into account their competencies) and, where necessary, engagement of external experts. | 1 | 1 |
| Manufacturing Inspection | ||
| Manufacturing inspection (initial, periodic (scheduled) and unscheduled). | ("standard inspection duration as determined in accordance with Table 1" − 1 person-day (standard labour intensity of the preparation stage) − 2 person-days (standard labour intensity of the report preparation stage) | The number of inspectors participating in the manufacturing inspection (initial, periodic (scheduled) and unscheduled) shall be determined by the documentary procedures of the inspecting organisations, but shall not exceed 4 persons. |
| Report Preparation | ||
| 1. Analysis of the verification processes during the manufacturing inspection. 2. Preparation of the manufacturing inspection report with a conclusion on the conformity (non-conformity) of the medical device quality management system with the requirements for its implementation for the verified groups (subgroups) of medical devices. | 2 | 2 |
5.3. The cost estimate per one working day of one inspector (Ce) shall be determined using the following formula:
Ce = SWavg / N, where:
SWavg — average monthly salary of one inspector, determined based on the required number of personnel directly involved in the provision of the service, taking into account their job category, in accordance with the current remuneration system and labour and/or collective agreements, RUB/person;
N — average monthly working time norm in days, determined as the approved annual working time norm (based on a 40-hour working week) for the year in which the service is provided, divided by 12 months.
The average monthly salary of one inspector (SWavg) shall be determined using the following formula:
SWavg = TWF / (12 × Navg), where:
TWF — total payroll fund for the preceding period for employees (inspectors) engaged in the provision of services, RUB;
Navg — average headcount of inspectors engaged in the provision of the service during the preceding period, persons.
5.4. The indirect costs of the inspecting organisation that cannot be directly attributed to the costs related to the provision of the service, taken into account when calculating the indirect cost ratio (Kind), shall include:
labour costs for administrative, managerial and support personnel associated with the provision of the service, including payroll contributions;
general overhead costs, including utility costs, communication services, transport services, acquisition of inventory, and property maintenance costs (hereinafter — general overhead costs) associated with the provision of the service;
depreciation of buildings, structures and other fixed assets associated with the provision of the service.
The indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service (Kind) shall be determined proportionally to the labour costs of inspectors directly involved in the service provision process, and shall be calculated on the basis of reporting data for the preceding period using the following formula:
Kind = ((LCmgmt + OCoverhead + Depr) / TWF) × 100, where:
LCmgmt — labour costs for administrative, managerial and support personnel associated with the provision of the service, including payroll contributions for the reporting period, RUB;
OCoverhead — general overhead costs associated with the provision of the service for the reporting period, RUB;
Depr — depreciation of buildings, structures and other fixed assets associated with the provision of the service for the reporting period, RUB;
TWF — total payroll fund of inspectors engaged in the provision of the service for the reporting period, RUB.
5.5. Travel expenses directly related to the provision of the service (Ctr) shall be determined using the following formula:
Ctr = (Ttravel + Taccom + Tper_diem + Tother) × Ninsp, where:
Ttravel — travel costs for one inspector to and from the destination for the provision of the service, RUB;
Taccom — accommodation costs for one inspector during the provision of the service, RUB;
Tper_diem — per diem allowance for one inspector during the provision of the service, RUB;
Tother — other travel expenses directly related to the provision of the service when travelling outside the Russian Federation (consular fee, life and health insurance for the travel period), RUB;
Ninsp — number of inspectors travelling to the manufacturing inspection site.
5.5.1. Travel costs for one inspector to and from the destination for the provision of the service (Ttravel) shall be determined at the amount of actual expenses confirmed by travel documents, but not exceeding the cost of travel by:
railway — in a compartment car of an express passenger train;
water transport — in a Category V cabin of a sea vessel on regular and comprehensive passenger service routes, in a Category II cabin of a river vessel on all routes, in a Category I cabin of a ferry vessel;
air transport — in economy class;
road transport — in a public motor vehicle (excluding taxi).
In the absence of travel documents confirming the expenses incurred, travel costs shall be determined at the minimum cost of travel by:
railway — in a reserved-seat car of a passenger train;
water transport — in a Category X cabin of a sea vessel on regular and comprehensive passenger service routes, in a Category III cabin of a river vessel on all routes;
road transport — in a standard bus;
air transport — in economy class.
5.5.2. Accommodation costs for one inspector during the provision of the service (Taccom) (except where the inspector on a business trip is provided with free accommodation) shall be set at the amount of actual expenses confirmed by relevant documents, provided that the hotel category shall not exceed 3 stars and the room category shall not exceed "standard".
The maximum per diem allowance for one inspector (Tper_diem) shall be established by the legislation of the Russian Federation:
within the territory of the Russian Federation — not more than RUB 700, and outside the territory of the Russian Federation — not more than RUB 2,500 per each day of the business trip, pursuant to paragraph 3 of Article 217 of Part Two of the Tax Code of the Russian Federation (Collection of Legislation of the Russian Federation, 2007, No. 31, Art. 4013; 2018, No. 45, Art. 6836).
5.5.3. Costs related to business trips outside the Russian Federation shall be determined in accordance with the established maximum reimbursement norms:
for accommodation during official business trips to foreign countries for federal civil servants, employees under employment contracts with federal state bodies, and employees of state extra-budgetary funds of the Russian Federation, in accordance with Resolution of the Government of the Russian Federation of 22 August 2020 No. 1267 "On Establishing Maximum Reimbursement Norms for Accommodation Costs during Official Business Trips to Foreign Countries for Federal Civil Servants, Employees under Employment Contracts with Federal State Bodies, Employees of State Extra-Budgetary Funds of the Russian Federation, Federal State Institutions, and on Invalidating Paragraph 10 of Resolution of the Government of the Russian Federation of 26 December 2005 No. 812" (Collection of Legislation of the Russian Federation, 2020, No. 35, Art. 5570);
for the amount and procedure for payment of per diems in foreign currency, in accordance with Resolution of the Government of the Russian Federation of 26 December 2005 No. 812 "On the Amount and Procedure for Payment of Per Diems in Foreign Currency and Supplements to Per Diems in Foreign Currency during Official Business Trips to Foreign Countries for Employees under Employment Contracts with Federal State Bodies, Employees of State Extra-Budgetary Funds of the Russian Federation, and Federal State Institutions" (Collection of Legislation of the Russian Federation, 2006, No. 2, Art. 187; 2020, No. 35, Art. 5570).
5.6. The fee for the manufacturing inspection service for medical devices shall not include costs associated with engaging interpreters during manufacturing inspections outside the Russian Federation.
The engagement of interpreters during manufacturing inspections outside the Russian Federation shall be carried out in accordance with the procedure established by the regulatory legal acts of the Eurasian Economic Union.
6. The fee for the service shall be reviewed no more than once a year, no later than 1 December of the year preceding the next financial year.
Annex No. 2
to Order of the Ministry of Health
of the Russian Federation
of 21 July 2020 No. 726n
MAXIMUM FEE
FOR THE SERVICE OF ASSESSING THE MANUFACTURING CONDITIONS
AND QUALITY MANAGEMENT SYSTEM OF A MEDICAL DEVICE MANUFACTURER
(MANUFACTURING INSPECTION) FOR COMPLIANCE WITH THE REQUIREMENTS
FOR THE IMPLEMENTATION, MAINTENANCE AND ASSESSMENT
OF THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES
DEPENDING ON THE POTENTIAL RISK OF THEIR APPLICATION
FOR THE PURPOSE OF REGISTRATION OF MEDICAL DEVICES
WITHIN THE EURASIAN ECONOMIC UNION
| Maximum service fee excluding travel expenses, RUB, VAT 20% included | Maximum travel expenses directly related to the provision of the service, RUB, VAT 20% included (within the Russian Federation) | Maximum service fee including travel expenses, RUB, VAT 20% included |
|---|---|---|
| 569,457.91 | 1,103,796 | 1,673,253.91 |
| Maximum service fee excluding travel expenses, RUB, VAT 20% included | Maximum travel expenses directly related to the provision of the service, RUB, VAT 20% included (outside the Russian Federation) | Maximum service fee including travel expenses, RUB, VAT 20% included |
|---|---|---|
| 569,457.91 | 1,848,387.72 | 2,417,845.63 |
Annex No. 1
to the Maximum Fee for the Service
of Assessing the Manufacturing Conditions
and Quality Management System
of a Medical Device Manufacturer
(Manufacturing Inspection) for Compliance
with the Requirements for the Implementation,
Maintenance and Assessment of the Quality
Management System for Medical Devices
Depending on the Potential Risk
of Their Application for the Purpose
of Registration of Medical Devices
within the Eurasian Economic Union,
approved by Order of the Ministry of Health
of the Russian Federation
of 21 July 2020 No. 726n
EXAMPLE
OF DETERMINING THE MAXIMUM FEE FOR THE SERVICE
OF ASSESSING THE MANUFACTURING CONDITIONS AND QUALITY
MANAGEMENT SYSTEM OF A MEDICAL DEVICE MANUFACTURER
(MANUFACTURING INSPECTION) OUTSIDE THE RUSSIAN FEDERATION
FOR COMPLIANCE WITH THE REQUIREMENTS FOR THE IMPLEMENTATION,
MAINTENANCE AND ASSESSMENT OF THE QUALITY MANAGEMENT SYSTEM
FOR MEDICAL DEVICES DEPENDING ON THE POTENTIAL RISK
OF THEIR APPLICATION FOR THE PURPOSE OF REGISTRATION
OF MEDICAL DEVICES WITHIN THE EURASIAN ECONOMIC UNION
Input data for calculation:
Assessment of the manufacturing conditions and quality management system of a medical device manufacturer (initial manufacturing inspection) where production is carried out outside the Russian Federation, for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their application for the purpose of registration of medical devices within the Eurasian Economic Union, based on an actual headcount at the inspection site of more than 5,000 persons, by an inspection team of 4 inspectors (on the condition that there are five processes within the scope of the inspection in accordance with paragraph 24 of the Requirements, two of which support the functioning of the quality management system and may be inspected by 1 inspector, while the remaining three core processes directly affecting the safety, quality and effectiveness of medical devices each require 1 inspector).
In accordance with the Methodology for Determining the Fee for the Service of Assessing the Manufacturing Conditions and Quality Management System of a Medical Device Manufacturer (Manufacturing Inspection) for Compliance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Application for the Purpose of Registration of Medical Devices within the Eurasian Economic Union, approved by this Order (hereinafter — the Methodology), the cost of the service shall be determined using the following formula:
C = t × Ce × (1 + (Kpay + Kind) / 100) + VAT + Ctr
In accordance with Table 1 of the Methodology, the standard duration of the initial manufacturing inspection with an actual headcount at the inspection site of more than 5,000 persons is 13 person-days. Given that the manufacturing inspection site (manufacturing site) is located in a different city from the inspecting organisation, the standard duration of the manufacturing inspection shall be increased by 2 person-days.
In accordance with Table 2 of the Methodology, the labour intensity (t) is 15 person-days, of which 1 person-day is the standard labour intensity of the preparation stage; 2 person-days — the standard labour intensity of the report preparation stage; 12 person-days — the standard labour intensity of the manufacturing inspection stage.
The cost estimate per one working day of one inspector (Ce) shall be determined using the following formula:
Ce = SWavg / N
SWavg — average monthly salary of one inspector, determined based on the required number of personnel directly involved in the provision of the service, taking into account their job category, in accordance with the current remuneration system and labour and/or collective agreements, RUB/person;
N — average monthly working time norm in days, determined as the approved annual working time norm (based on a 40-hour working week) for the year in which the service is provided, divided by 12 months.
The average monthly salary of one inspector (SWavg) shall be determined using the following formula:
SWavg = TWF / (12 × Navg)
TWF — total payroll fund for the period for employees (inspectors) engaged in the provision of services, RUB;
Navg — average headcount of inspectors engaged in the provision of the service during the reporting period, persons.
SWavg = 9,638,492.49 / (12 × 4) = 200,801.93 RUB/person
Ce = 200,801.93 / 20.58 = 9,757.14 RUB/person/day
Kpay — payroll contribution rate in accordance with the legislation of the Russian Federation, equal to 30.2 percent.
The indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service (Kind) shall be determined proportionally to the labour costs of inspectors directly involved in the service provision process, and shall be calculated on the basis of reporting data using the following formula:
Kind = ((LCmgmt + OCoverhead + Depr) / TWF) × 100
LCmgmt — labour costs for administrative, managerial and support personnel associated with the provision of the service, including payroll contributions for the reporting period, RUB;
OCoverhead — general overhead costs associated with the provision of the service for the reporting period, RUB;
Depr — depreciation of buildings, structures and other fixed assets associated with the provision of the service for the reporting period, RUB;
TWF — total payroll fund of inspectors directly engaged in the provision of the service for the reporting period, RUB.
The calculation of the indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service, determined on the basis of accounting data for the reporting period, is set out in Table 3.
Table 3
| No. | Abbreviation | Cost item | Amount (RUB) |
|---|---|---|---|
| 1 | 2 | 3 | 4 |
| 1 | LCmgmt | Labour costs for administrative, managerial and support personnel associated with the provision of the service, including payroll contributions for the reporting period | 91,650,302.88 |
| 2 | OCoverhead | General overhead costs associated with the provision of the service for the reporting period | 37,188,138.77 |
| including: | |||
| 2.1 | Communication services costs | 972,499.32 | |
| 2.2 | Utility costs | 5,935,672.51 | |
| 2.3 | Transport services costs | 671,209.62 | |
| 2.4 | Property maintenance costs | 6,662,504.72 | |
| 2.5 | Inventory acquisition costs | 22,946,252.60 | |
| 3 | Depr | Depreciation of buildings, structures and other fixed assets associated with the provision of the service for the reporting period | 55,449,751.89 |
| 4 | Total | Indirect costs (item 1 + item 2 + item 3) | 184,288,193.54 |
| 5 | TWF | Total payroll fund of inspectors engaged in the provision of the service for the reporting period | 94,975,203.35 |
The indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service, as a percentage (item 4 / item 5) × 100, equals 194.04.
Travel expenses using the formula:
Ctr = (Ttravel + Taccom + Tper_diem + Tother) × Ninsp
Ttravel — travel costs for one inspector to and from the destination for the provision of the service, RUB;
Taccom — accommodation costs for one inspector during the provision of the service, RUB;
Tper_diem — per diem allowance for one inspector during the provision of the service, RUB;
Tother — other travel expenses directly related to the provision of the service when travelling outside the Russian Federation (consular fee, life and health insurance for the travel period), RUB;
Ninsp — number of inspectors travelling to the manufacturing inspection site.
| Type of expense | Unit cost, RUB | No. of business trip days | No. of inspectors, persons |
|---|---|---|---|
| Per diems (outside the Russian Federation) | 2,500 | 3 | 4 |
| Air and rail tickets (round trip), outside the Russian Federation | 389,661 | — | 4 |
| Accommodation | 17,318.13 | 3 | 4 |
| Consular fee | 10,657.31 | — | 4 |
| Insurance for the period of travel outside the Russian Federation | 1,274.23 | — | 4 |
| Roaming communication costs | 350 | 3 | 4 |
Ctr = (2,500 × 3 + 389,661 + 17,318.13 × 3 + 10,657.31 + 1,274.23 + 350 × 3) × 4 = 1,848,387.72 RUB
C = t × Ce × (1 + (Kpay + Kind) / 100) + VAT + Ctr = (15 × 9,757.14 × (1 + (30.2 + 194.04) / 100)) + 20% VAT + 1,848,387.72 = 474,548.26 + 20% VAT + 1,848,387.72 = 569,457.91 + 1,848,387.72 = 2,417,845.63 RUB
where:
t = 15 person-days — labour intensity of the assessment of the manufacturing conditions and quality management system of a medical device manufacturer (manufacturing inspection) for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their application;
Ce = 9,757.14 RUB/person/day — cost estimate per one working day of one inspector;
Kpay = 30.2 percent — payroll contribution rate in accordance with the legislation of the Russian Federation;
Kind = 194.04 percent — indirect cost ratio of the organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service;
Ctr = 1,848,387.72 RUB — travel expenses directly related to the provision of the service outside the Russian Federation.
Annex No. 2
to the Maximum Fee for the Service
of Assessing the Manufacturing Conditions
and Quality Management System
of a Medical Device Manufacturer
(Manufacturing Inspection) for Compliance
with the Requirements for the Implementation,
Maintenance and Assessment of the Quality
Management System for Medical Devices
Depending on the Potential Risk
of Their Application for the Purpose
of Registration of Medical Devices
within the Eurasian Economic Union,
approved by Order of the Ministry of Health
of the Russian Federation
of 21 July 2020 No. 726n
EXAMPLE
OF DETERMINING THE MAXIMUM FEE FOR THE SERVICE
OF ASSESSING THE MANUFACTURING CONDITIONS AND QUALITY
MANAGEMENT SYSTEM OF A MEDICAL DEVICE MANUFACTURER
(MANUFACTURING INSPECTION) LOCATED WITHIN THE RUSSIAN FEDERATION
FOR COMPLIANCE WITH THE REQUIREMENTS FOR THE IMPLEMENTATION,
MAINTENANCE AND ASSESSMENT OF THE QUALITY MANAGEMENT SYSTEM
FOR MEDICAL DEVICES DEPENDING ON THE POTENTIAL RISK
OF THEIR APPLICATION FOR THE PURPOSE OF REGISTRATION
OF MEDICAL DEVICES WITHIN THE EURASIAN ECONOMIC UNION
Input data for calculation:
Assessment of the manufacturing conditions and quality management system of a medical device manufacturer (initial manufacturing inspection) where production is carried out within the Russian Federation, for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their application for the purpose of registration of medical devices within the Eurasian Economic Union, based on an actual headcount at the inspection site of more than 5,000 persons, by an inspection team of 4 inspectors (on the condition that there are five processes within the scope of the inspection in accordance with paragraph 24 of the Requirements, two of which support the functioning of the quality management system and may be inspected by 1 inspector, while the remaining three core processes directly affecting the safety, quality and effectiveness of medical devices each require 1 inspector).
In accordance with the Methodology for Determining the Fee for the Service of Assessing the Manufacturing Conditions and Quality Management System of a Medical Device Manufacturer (Manufacturing Inspection) for Compliance with the Requirements for the Implementation, Maintenance and Assessment of the Quality Management System for Medical Devices Depending on the Potential Risk of Their Application for the Purpose of Registration of Medical Devices within the Eurasian Economic Union, approved by this Order (hereinafter — the Methodology), the cost of the service shall be determined using the following formula:
C = t × Ce × (1 + (Kpay + Kind) / 100) + VAT + Ctr
In accordance with Table 1 of the Methodology, the standard duration of the initial manufacturing inspection with an actual headcount at the inspection site of more than 5,000 persons is 13 person-days. Given that the manufacturing inspection site (manufacturing site) is located in a different city from the inspecting organisation, the standard duration of the manufacturing inspection shall be increased by 2 person-days.
In accordance with Table 2 of the Methodology, the labour intensity (t) is 15 person-days, of which 1 person-day is the standard labour intensity of the preparation stage; 2 person-days — the standard labour intensity of the report preparation stage; 12 person-days — the standard labour intensity of the manufacturing inspection stage.
The cost estimate per one working day of one inspector (Ce) shall be determined using the following formula:
Ce = SWavg / N
SWavg — average monthly salary of one inspector, determined based on the required number of personnel directly involved in the provision of the service, taking into account their job category, in accordance with the current remuneration system and labour and/or collective agreements, RUB/person;
N — average monthly working time norm in days, determined as the approved annual working time norm (based on a 40-hour working week) for the year in which the service is provided, divided by 12 months.
The average monthly salary of one inspector (SWavg) shall be determined using the following formula:
SWavg = TWF / (12 × Navg)
TWF — total payroll fund for the period for employees (inspectors) engaged in the provision of services, RUB;
Navg — average headcount of inspectors engaged in the provision of the service during the reporting period, persons.
SWavg = 9,638,492.49 / (12 × 4) = 200,801.93 RUB/person
Ce = 200,801.93 / 20.58 = 9,757.14 RUB/person/day
Kpay — payroll contribution rate in accordance with the legislation of the Russian Federation, equal to 30.2 percent.
The indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service (Kind) shall be determined proportionally to the labour costs of inspectors directly involved in the service provision process, and shall be calculated on the basis of reporting data for the preceding period using the following formula:
Kind = ((LCmgmt + OCoverhead + Depr) / TWF) × 100
LCmgmt — labour costs for administrative, managerial and support personnel associated with the provision of the service, including payroll contributions for the reporting period, RUB;
OCoverhead — general overhead costs associated with the provision of the service for the reporting period, RUB;
Depr — depreciation of buildings, structures and other fixed assets associated with the provision of the service for the reporting period, RUB;
TWF — total payroll fund of inspectors directly engaged in the provision of the service for the reporting period, RUB.
The calculation of the indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service, determined on the basis of accounting data for the reporting period, is set out in Table 4.
Table 4
| No. | Abbreviation | Cost item | Amount (RUB) |
|---|---|---|---|
| 1 | 2 | 3 | 4 |
| 1 | LCmgmt | Labour costs for administrative, managerial and support personnel associated with the provision of the service, including payroll contributions for the reporting period | 91,650,302.88 |
| 2 | OCoverhead | General overhead costs associated with the provision of the service for the reporting period | 37,188,138.77 |
| including: | |||
| 2.1 | Communication services costs | 972,499.32 | |
| 2.2 | Utility costs | 5,935,672.51 | |
| 2.3 | Transport services costs | 671,209.62 | |
| 2.4 | Property maintenance costs | 6,662,504.72 | |
| 2.5 | Inventory acquisition costs | 22,946,252.60 | |
| 3 | Depr | Depreciation of buildings, structures and other fixed assets associated with the provision of the service for the reporting period | 55,449,751.89 |
| 4 | Total | Indirect costs (item 1 + item 2 + item 3) | 184,288,193.54 |
| 5 | TWF | Total payroll fund of inspectors engaged in the provision of the service for the reporting period | 94,975,203.35 |
The indirect cost ratio of the inspecting organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service, as a percentage (item 4 / item 5) × 100, equals 194.04.
Travel expenses using the formula:
Ctr = (Ttravel + Taccom + Tper_diem) × Ninsp
Ttravel — travel costs for one inspector to and from the destination for the provision of the service, RUB;
Taccom — accommodation costs for one inspector during the provision of the service, RUB;
Tper_diem — per diem allowance for one inspector during the provision of the service, RUB;
Ninsp — number of inspectors travelling to the manufacturing inspection site.
| Type of expense | Unit cost, RUB | No. of business trip days | No. of inspectors, persons |
|---|---|---|---|
| Per diems (within the Russian Federation) | 700 | 3 | 4 |
| Air and rail tickets (round trip), within the Russian Federation | 247,449 | — | 4 |
| Accommodation | 8,800 | 3 | 4 |
Ctr = (700 × 3 + 247,449 + 8,800 × 3) × 4 = 1,103,796 RUB
C = t × Ce × (1 + (Kpay + Kind) / 100) + VAT + Ctr = (15 × 9,757.14 × (1 + (30.2 + 194.04) / 100)) + 20% VAT + 1,103,796 = 474,548.26 + 20% VAT + 1,103,796 = 569,457.91 + 1,103,796 = 1,673,253.91 RUB
where:
t = 15 person-days — labour intensity of the assessment of the manufacturing conditions and quality management system of a medical device manufacturer (manufacturing inspection) for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their application;
Ce = 9,757.14 RUB/person/day — cost estimate per one working day of one inspector;
Kpay = 30.2 percent — payroll contribution rate in accordance with the legislation of the Russian Federation;
Kind = 194.04 percent — indirect cost ratio of the organisation for costs that cannot be directly attributed to the costs directly related to the provision of the service;
Ctr = 1,103,796 RUB — travel expenses directly related to the provision of the service within the Russian Federation.