Equipping a dental office for licensing

Licensing procedure

Article 12 of Federal Law No. 99-FZ of May 4, 2011, which defines the general licensing rules in Russia, establishes that all types of medical activities are classified as licensed. A specific list of areas of dentistry in the license is given in an additional regulatory document - Government Decree No. 291 of April 16, 2012. It includes the following areas of work activity of a doctor in dentistry:

• hygienic;
• general;
• children's;
• area of ​​general practice;
• orthopedic;
• preventive;
• therapeutic;
• surgical

Each of these areas requires a separate license. To obtain it, the applicant will have to study the list for a dental office license, which describes the necessary equipment. The issuance of such documents is carried out by Roszdravnadzor and relevant departments of regional executive authorities.

To obtain a license, the applicant provides the regulatory agency with a package of documents confirming that he meets the established standards and has purchased the necessary equipment in quantities not less than the established one. Based on the results of consideration of the application, a decision is made to grant a license or refuse to issue it. If the decision is positive, the validity period of such a document is not limited in accordance with Part 4 of Article 9 of 99-FZ.

Required documents

To obtain a license to operate a dental clinic, the applicant will need to draw up an application according to the established template. It is given in the appendix to Roszdravnadzor Order No. 3166 dated May 5, 2014. You will need to attach a list of documents to it that will confirm that you have fulfilled the current requirements for licensing orthodontists or other dentists and are ready to start working. The list of such documents includes:

• notarized copies of the company’s constituent documentation;
• copies of documents confirming the legal right to use premises suitable for the provision of services and having an area not less than the established one - for example, a certificate of ownership or a lease agreement;
• copies of documents indicating that the applicant has the legal right to use medical equipment and equipment in an amount not less than necessary to perform work in the chosen field of dentistry;
• information on the compliance of the existing premises with sanitary and epidemiological safety standards;
• copies of registration certificates for the equipment used;
• copies of diplomas, certificates and certificates confirming that the head of the organization and its doctors have the required level of education, qualifications and work experience in the relevant profile that is not less than established - for example, this is a physiotherapy room for licensing a dental organization or a functional diagnostics room;
• copies of diplomas or certificates of staff members who will be involved in the maintenance of medical equipment, or a copy of the agreement with the organization that will provide such maintenance;
• a copy of the receipt confirming payment of the state fee for the provision of the service for issuing a license;
• a list of documents provided as part of the package.

List of required equipment

One of the important licensing conditions that the applicant must meet is the equipment of dentistry for licensing, that is, the availability of medical equipment in an amount no less than necessary to provide quality services. This issue is regulated by a separate legal act - order of the Ministry of Health dated December 7, 2011 N 1496n. Appendix No. 11 to this order provides the current standards for equipping different types of dental offices for licensing. This section of the document contains standards for:

• general practice offices as part of a dental clinic;
• therapeutic, surgical, orthopedic dentistry offices as part of a specialized clinic;
• a dental laboratory operating as part of a specialized clinic;
• an orthodontic, physiotherapeutic, x-ray room as part of a dental clinic, as well as a functional diagnostics room and a mobile unit;
• centralized sterilization unit as part of the clinic.

The required dental equipment for a license given in the document is differentiated for organizations in which doctors provide inpatient and outpatient care to patients.

ATTEK center services

The ATTEK Center has been providing support for licensing applications for dental clinics and offices for many years. This is one of the core areas of our activity, which is handled by highly professional employees. They thoroughly know the standards of current legislation and regulatory authorities in this area, and in addition, they regularly monitor current legislation for changes. We offer you a full range of work that allows you to quickly obtain a dental license.

Is it necessary to be a dentist?

The dental business is a good investment, but many people avoid it due to the lack of specialized education. Typically, specialists who already have experience working in public or private medical institutions go into this niche. However, even an inexperienced startuper, with appropriate theoretical training, can open a successful dental office. The main thing is the professionalism of dentists.

As for legal requirements, when opening an individual entrepreneur, a businessman must have a specialized education. When registering an LLC, medical education is not required.

Equipment for dental organizations: regulatory framework

So, the list of main regulatory documents that regulate the standards for equipping a general dentistry office for licensing and other types of dental organizations includes:

• Federal Law of November 21, 2011 No. 323-FZ, dedicated to issues of protecting the health of citizens;
• Sanitary and epidemiological requirements for medical organizations SanPiN 2.1.3.2630-10, approved by Resolution of the Chief State Sanitary Doctor of May 18, 2010 No. 58;
• Decree of the Government of the Russian Federation of April 16, 2012 No. 291, establishing the procedure for licensing medical activities;
• current Order of the Ministry of Health dated December 7, 2011 No. 1496n, which defines the rules for the provision of dental care to adult citizens by doctors;
• Order of the Ministry of Health of November 13, 2012 No. 910n, establishing the rules for the provision of dental care to children by doctors;
• new Order of the Ministry of Health dated July 31, 2022 No. 786n, introducing an updated procedure for the provision of dental services to the adult population by doctors.

New rules for equipping dentistry from 2022

From January 1, 2022, a new list of dental office equipment for licensing will come into force in Russia, approved by Order of the Ministry of Health No. 786n. The procedure for its operation is determined by an additional regulatory document - Order of the Ministry of Health dated June 9, 2022 No. 560n, which also comes into force on January 1, 2022.

The new equipment rules involve the following changes to the current procedure:

• In addition to the required number of doctors, each dental office must install its own dental X-ray machine with a digital image receiver. This technique will require the hiring of specialized personnel, including radiologists, and consequently, the permitted organizational and legal forms of organizations that are allowed to engage in this type of work activity will also change. Individual entrepreneurs are prohibited from working with such installations: they will have to re-register as an LLC;
• operating LLCs, whose list of working equipment for licensing a dental office previously included only a visiograph, will be required to purchase a panoramic X-ray machine. This means they will need a larger room, since each installation will require at least 4 square meters of additional space.

The operation of additional working equipment must be carried out in accordance with SanPiN 2.6.1.1192-03, approved by Resolution of the Chief State Sanitary Doctor of February 18, 2003 No. 8: they regulate the rules of work for doctors in X-ray rooms. In addition, when making changes to the standard list of equipment for equipping a dental laboratory for licensing, all organizations will need to re-issue documents for the equipment, which, of course, will require additional time and financial costs.

Brief market analysis

Dentistry has been a leader in the ranking of commercial areas since 2010.

If you look at the ratio of public and private institutions in Moscow, you will find that budget ones account for only 4%. That is, the remaining 96% are commercial organizations. Hence the conclusion: competition in the industry is high.

However, it is not competitors who pose more obstacles to a novice businessman, but the state, which puts forward strict requirements for premises, licensing, certification, and installation of x-ray equipment.

The most sought-after specialists in the industry are surgeons and therapists. Orthodontists follow them. Generalist doctors account for 11% of demand, another 6% for pediatric specialists. Every year prosthetics becomes more popular.

According to an analysis by the Russian Ministry of Health, in 2019-2021, industry growth will be about 12% per year. Such forecasts are due to the high profitability and short payback period of dental institutions. So, in the capital the profit volume is 30%, in the provinces – 20%.

Requirements for dental equipment

One of the key standards that a dental organization must satisfy in order to obtain a license to conduct its activities is compliance with established standards for equipping it with equipment and tools. The current list of drugs and equipment for organizing a dental office is contained in Resolution No. 1496n. It contains lists of required items, the number of which is calculated depending on various factors, including:

• number of doctors' jobs;
• the number of divisions operating in the organization;
• the required number of types of equipment per organization;
• number of patient visits;
• number of doctor positions;
• number of assistant jobs;
• number of shells;
• other criteria.

Some types of positions are acquired by the organization at its own discretion if necessary - but not less than the minimum values.

General requirements

According to Resolution No. 1496n, the preparation of a list of equipment for dental offices for licensing must be carried out in accordance with the type of organization and the profile of its working activities. The appendices to this regulatory document separately formulate standards for the following types of dental institutions.

Office or clinic: which format to choose?

The format depends on your ambitions and budget.

Any institutions providing dental services are divided into 3 categories:

1. Economy class. Firms use a preferential tax system and usually have difficulty staffing with highly qualified dentists. The average check is $150 - $300. This includes dental offices of clinics and medical budget centers.
2. Business segment. A visit costs about $1000. Due to the high level of profitability, clinics have the opportunity to hire experienced doctors and staff, equip offices with modern equipment, and use innovative treatment techniques.
3. VIP clinics. For people interested in high quality service. The client pays about $1,500 per session.

Now let's look at what it takes to open a dental office.

Standards for different types of organizations

For specialized departments of dental clinics, the list of equipment for licensing a dental office most often contains 100 or more items. For auxiliary units it is somewhat shorter, but also requires a fairly serious approach to equipping everything necessary.

Equipment standard for the radiology department of the clinic

*Items that are required to be equipped only when using (declaring) a technology that involves the use of these devices, tools, and medications. **Offices and rooms are equipped in which it is not possible to meet sanitary and hygienic requirements with the existing stationary ventilation and air conditioning systems. ***In accordance with sanitary and epidemiological rules and regulations.

Standard for equipping a functional diagnostics unit in dentistry for a specialized clinic

*Items that are required to be equipped only when using (declaring) a technology that involves the use of these devices, tools, and medications. **Offices and rooms are equipped in which it is not possible to meet sanitary and hygienic requirements with the existing stationary ventilation and air conditioning systems. ***In accordance with sanitary and epidemiological rules and regulations.

Room

According to Rospotrebnadzor standards, the minimum area for a private dental office is 30 m² (of which at least 14 m² is allocated for a room with a chair and equipment, 10 m² for a hall, 5 m² for a sanitary and hygienic area). The minimum ceiling height is 3 meters, the distance from the window to the wall is 6 meters.

If the dentistry has more than 3 dental units, a separate room for sterilization (6 m²) will be required.

The area of ​​the X-ray room is 11 m², the developing room is 6 m².

For orthodontist and orthopedist offices – 15 m² each. For others (for a pediatrician, implantology) – also 15 m².

Additional rooms (warehouse, premises for employees, administration) – 30 m².

Dental attendance depends on the location of the premises, so it is better to give preference to areas with high foot traffic. For sparsely populated regions with a small number of competitors, this condition is not critical.

How much does it cost to open a dental office: financial plan with calculations

Cost items for a startup:

• Registration, obtaining licenses and permits – 60,000 rubles.
• Rent of premises – 60,000 rubles.
• Repair and finishing work, furniture – 300,000 rubles.
• Equipment, materials – 1,200,000 rubles (for 3 jobs).
• Marketing (advertising sign, leaflets, brochures, business cards, website, advertisements in the media, on forums) – 70,000 rubles.
• Other expenses – 100,000 rubles.

Monthly expenses:

• Salary - 270,000 rubles.
• Rent - 60,000 rubles.
• Utility bills - 20,000 rubles.
• Taxes - 30,000 rubles.
• Maintenance of equipment and purchase of materials - 8,000 rubles.

In this business plan, we are considering opening an economy class office. The average bill per client in Russia is $50 (3,400 rubles). If 3 specialists work and there are 12 clients per day, the average daily revenue will be 40,800 rubles.

Table No. 3. Financial indicators

3 months is an optimistic forecast that will only come true if the account is fully loaded. You need to be prepared for the fact that at first there will be few clients and the payback period will be longer.

FAQ

What is therapeutic dentistry?

This is a branch of dentistry that deals with the study, diagnosis, treatment and prevention of diseases of the teeth, tissues surrounding the tooth, and the oral mucosa.

Which doctor treats caries?

The dentist-therapist deals with the treatment of caries, as well as the treatment of non-carious lesions of teeth.

What does a dental therapist treat?

A dentist treats caries, gingivitis, non-carious damage to teeth, fills teeth, restores teeth after injury (chips, fractures), corrects cosmetic defects using direct restoration, treats diseases of the gums and mucous membranes, gives recommendations on the prevention of dental diseases and proper hygiene.

Equipment

Table No. 1. Dental materials

The main positions are listed, but in reality the list is wider. You will also need sealing devices, lubrication and cleaning equipment, air conditioners, and humidifiers. Installations, tools, and materials must have certificates.