Adjustment of positions in the list of medical products not subject to VAT

Classification of VAT benefits

Exemption from VAT is provided for in Article 149 of the Tax Code of the Russian Federation. Everyone knows that benefits under this article are provided to:

• when selling certain types of goods (works, services);
• certain categories of firms and entrepreneurs;
• when carrying out certain operations.

The first group of preferential goods includes medical goods. And many are mistaken in believing that the only requirement for their VAT exemption is compliance with the government list.

Methods for calculating prices for various medical products

4.1. The procedure for calculating the price of medical devices that relate to medical devices provided for by the special order of the Government of the Russian Federation dated December 30, 2005 N 2347-r.

This order established the Federal List of Rehabilitation Measures, Technical Rehabilitation Equipment and Services Provided to Disabled Persons. These include:

• Support and tactile canes, crutches, supports, handrails.
• Wheelchairs with manual drive (indoor, walking, active type), with electric drive and batteries for them, small-sized.
• Prostheses and orthoses.
• Orthopedic shoes.
• Anti-decubitus mattresses and pillows.
• Devices for dressing, undressing and grasping objects.
• Special clothing.
• Special devices for reading “talking books”, for optical correction of low vision.
• Guide dogs with a set of equipment (not MI)
• Medical thermometers and tonometers with speech output.
• Light and vibration sound alarms.
• Hearing aids, including custom-made earmolds.
• Televisions with teletext to receive programs with closed captioning (not MI)
• Telephone devices with video calling, navigation and text output (not MI)
• Voice-forming devices.
• Special means for violations of excretory functions (urine and colostomy bags) (We do not use Order 450n, MI falls under exceptions)
• Absorbent underwear, diapers.
• Chairs with sanitary equipment.
• Braille display, screen reading software.

When purchasing these goods, we apply the usual procedure for justifying prices using the method of comparable market prices in accordance with Article 22 of Law 44-FZ, but for calculations we use exclusively prices obtained from information sources listed in the order of the Government of the Russian Federation dated September 18, 2017 N 1995-r:

4.2. When purchasing medical equipment for which state price regulation has been established

Such medical products include medical devices included in the state register of maximum selling prices of manufacturers for medical devices https://roszdravnadzor.gov.ru/services/mi_prices. For example, stents or prostheses implanted into the human body during the provision of medical care within the framework of the state guarantee program for the provision of free medical care to citizens.

In such procurements, the customer must use the tariff method or market analysis in accordance with Art. 22 of Law 44-FZ. But at the same time, the calculated price cannot exceed the price determined by the tariff method. Thus, the customer will still have to calculate the price using two methods and choose the minimum price from them. Using market analysis, the customer can already apply prices obtained from any sources of information provided for in Part 5 and Part 18 of Article 22 of Law 44-FZ.

4.3. When purchasing other medical devices

Order 450n established the possibility in such procurements to use at the customer’s choice (one or both at the same time):

In order to determine the homogeneity of the set of values ​​of identified prices used in calculations in accordance with Order 450n, the customer determines the coefficient of variation using the standard formula established by Order of the Ministry of Economic Development of the Russian Federation dated October 2, 2013 N 567 (the set of values ​​used in the calculation is considered heterogeneous if the coefficient of price variation exceeds 33%. In this case, it is advisable to conduct additional research to increase the amount of price information used in the calculation).

The indicated price is calculated as a weighted average. The formula is not established by Order 450n, but we believe it is possible to use the standard mathematical formula:

where C is the price of a unit of medical devices excluding VAT, k is the number of identical medical devices purchased.

VAT benefit for medical goods

Medical products belong to the group of socially significant goods.

The sale of medical goods of domestic and foreign production according to the list approved by Government Decree No. 1042 of September 30, 2015 (subclause 1, clause 2, article 149 of the Tax Code of the Russian Federation) is exempt from VAT taxation:

1. medical products when submitting a registration certificate to the inspection;
2. prosthetic and orthopedic products, raw materials, materials and semi-finished products for their manufacture;
3. technical means, including motor vehicles, materials that can be used exclusively for the prevention of disability or rehabilitation of disabled people (including specially equipped means of transport intended exclusively for transporting disabled people);
4. corrective glasses (for vision correction), lenses for vision correction, frames for glasses for vision correction.

This, as you know, is a general list of preferential goods, without specifics. Their specific types with codes according to OKVED2 and TN ED EAEU can be found in the mentioned government list.

When carrying out which methods of determining a supplier the procedure is used

The general rule applies - we apply Order 450n only in those purchases for which it is necessary to justify the price in accordance with Article 22 of Law 44-FZ:

• all competitive methods,
• procurement of medical products from a single supplier in the cases established in Part 4 of Article 93 of Law 44-FZ. For example:
• when purchasing under clause 4, part 1, article 93 of Law 44-FZ (“small purchases”) - there is no need to apply Order 450n,
• when purchasing under clauses 3, 6, 9 (“urgent purchases”), 11, 12, 35, 40, 41, 46, part 1, article 93 of Law 44-FZ, Order 450n must be applied.

How to apply VAT benefits on medical goods

So, the general requirement for VAT exemption for all medical goods is inclusion in the list approved by Resolution No. 1042.

But there are additional conditions.

To exempt medical products from VAT, a registration certificate issued by the Ministry of Health is required. The rules for state registration of medical devices were approved by Government Decree No. 1416 of December 27, 2012. The registration certificate is a document confirming registration. It is presented to the inspectorate to confirm the right to the benefit.

For the preferential sale of other goods, a registration certificate is not required to be submitted to the tax office. This clarification was in the letter of the Ministry of Finance dated August 9, 2021 No. 03-07-07/56276.

However, starting next year, a new condition will appear to confirm the right to benefits for certain types of motor vehicles.

An important feature of Order 450n

An important feature of Order 450n is the need to calculate the price of a medical device taking into account the cost of all consumables and carry out maintenance during the warranty period of its operation.

In fact, the customer makes a three-in-one purchase - the product itself, consumables for the warranty period and maintenance services during the warranty period.

The exception is cases when the manufacturer's (manufacturer's) operational documentation does not provide for the use of consumables and (or) maintenance during the warranty period of the medical device.

The order proposes to use the following formulas for calculation:

Important for calculation!

• What are considered consumables?

Products and (or) components consumed during the operation of the medical device and ensuring the use of the medical device for medical purposes in accordance with its functional purpose, information about which is contained in the operational documentation of the manufacturer (manufacturer) for the medical device (clause 6 of Order 450n).

• What warranty period for the operation of the device should be taken for calculation?
• The basis is operational documentation for medical devices (clause 7 of Order 450n).
• The period must be at least 12 months.
• If there is no information about the warranty period - 24 months. from the date of transfer of the medical device to the customer.
• Used to calculate the cost of consumables (CPM) and the cost of maintenance services (STO) for the warranty period.
• How to calculate the need for consumables and (or) maintenance services during the warranty period?

Taking into account the planned intensity of operation of the medical device planned for purchase based on the volume of medical care provided (planned to be provided) by the medical organization with the use (planned use) of the medical device in accordance with clinical recommendations, procedures for the provision of medical care and standards of medical care (clause 8 of Order 450n) .

• When calculating maintenance costs, it is necessary to be guided by the types of maintenance and the requirements for it established by the national standard GOST R 58451-2019 “Medical products. Technical maintenance. Basic provisions”, as well as GOST R 56606-2015 “Monitoring the technical condition and functioning of medical devices. Basic provisions". In particular, the types of maintenance include: periodic maintenance, unscheduled maintenance, technical diagnostics, repairs, technical condition monitoring, installation/dismantling/adjustment.
• The customer must draw up a list of all consumables necessary for the operation of each item of the medical product during the warranty period of its operation. The cost is calculated according to the formula (clause 13 of Order 450n):

Where:

СРМi – the cost of all consumables necessary for the operation of the medical product of the i-th position during the warranty period, excluding VAT;

СРМy – the cost of consumables of the y-th position for a medical product of the i-th position, used during the warranty period of operation of this medical product, excluding VAT;

y – position of purchased consumables;

k is the number of items of consumables purchased for the medical product of the i-th item.

Medical equipment certification

Medical equipment must comply with domestic GOST requirements. Certification of most medical equipment is carried out in an accredited certification center in the form of issuing a declaration of conformity, with the exception of safety glasses, for which a certificate of conformity is issued.

In addition to mandatory certification, medical equipment can undergo voluntary certification. A voluntary certificate inspires greater consumer confidence and expands the ability to find markets and partnerships.

Only a domestic company can apply for a declaration of conformity, so foreign manufacturers must act through a representative. In addition to the application, the certification center sells:

• OGRN, TIN, charter of the enterprise;
• Company details;
• equipment description;
• foreign trade contract.

In addition, you need to obtain a certificate of state registration from Rospotrebnadzor. Without this document, declarations and certificates of conformity are not issued. Certification is carried out in the form of laboratory tests of product samples, as a result of which a test report is drawn up, and on its basis a main document is issued.