Dentistry is one of the most popular types of medical activities. As in any other healthcare sector, dental clinics and specialists must undergo mandatory medical licensing.

Types of licensing divide the entire field of dentistry into pediatric and adult departments, preventive work, orthodontics, surgery and other types of services. Each branch of dentistry requires its own license.

A special type of work by specialists is using precious stones and metals. Increased requirements have been established for this area. Specialists from the Legal Resolution Company will help you obtain a license that allows you to start such activities.

The cost of licensing dental activities

All medical activities are regulated by the Licensing Regulations and controlled by Roszdravnadzor. The cost of obtaining a license is 7,500 rubles. The price is standard and is a state duty established by law. However, obtaining the necessary certificates, confirmations and permits usually requires additional costs.

After collecting documents and submitting them to the authorized licensing authorities, you should wait for a response within 45 business days. You can submit documents and receive a response as follows:

• personal appeal;
• through legal representatives;
• using postal and courier services;
• by email – through the government services portal.

How to obtain a dental license

A complete list of provisions and resolutions according to which licensing of dental activities is carried out is publicly available. Licensing must meet the requirements of the following documents:

• Federal Laws on Licensing of Medical Services;
• legislative acts on the protection of human health;
• SanPins;
• requirements for working conditions prescribed in the Labor Code of the Russian Federation.

Licensing dental activities is a responsible and important event before opening your own commercial business. The legislation of the Russian Federation regulates all the requirements that an applicant must fulfill in order to obtain a document confirming the licensing of activities in the field of dentistry. These include:

• the applicant has documents confirming ownership of real estate and equipment involved in dental activities;
• compliance of the medical office (center) with generally established requirements;
• availability of certificates and technical passports of all medical equipment;
• the presence of higher or secondary medical education among the main staff;
• availability of education and minimal experience in the planned type of detail among the management team;
• possession of technologies that can provide advanced training for the entire staff;
• the applicant has a medical education.

These requirements apply to the licensing of dental services provided in the clinic. In the case of licensing of an individual entrepreneur, the activity provides for significant restrictions. For example, the applicant himself, an individual entrepreneur, and not hired personnel, must be directly involved in the provision of dental services.

Licensing of dentistry specializing in implantology, radiography and other specific types of activities is regulated on an individual basis with increased requirements for the technical equipment of workplaces.

The optimal solution is to license activities with the help of specialized legal organizations. The Legal Resolution company offers its services for obtaining a license for all types of medical activities, collecting a package of documents and completing the necessary applications. Ordering a turnkey license will save the customer from many problems and save time. In addition, highly qualified specialists offer support throughout the entire process and advice on related issues.

Answer: Yes, it is possible to obtain a medical license provided that your medical activity is carried out by a legal entity employing a general practitioner with less than 5 years of work experience. In this case, it is necessary to provide an additional position, for example, deputy director for medical treatment, which can be filled by a specialist with any medical education and experience in his main specialty for at least 5 years.

Question: I am an individual entrepreneur. I want to open a medical office to provide pediatric care. Will this be legal provided that the hired workers are pediatricians of the highest category with a licensed license? Or do I also need to apply for a license? By education I am a paramedic, but I received my diploma back in 1989. I worked in my specialty for about a year?

Answer: In accordance with the Regulations on licensing of medical activities, approved by Decree of the Government of the Russian Federation of January 22, 2007 N 30, individual entrepreneurs have the right to carry out medical activities on the territory of the Russian Federation. However, for this it is necessary to fulfill the conditions that are defined in the said Regulations. One of these conditions is that an individual entrepreneur - a license applicant (licensee) has a higher (secondary - in the case of performing work (services) for pre-medical care) professional (medical) education, postgraduate or additional professional (medical) education and work experience in a specialty not less than 5 years. If you want to declare this type of activity as pediatrics, then you must have appropriate education and experience as a pediatrician for at least 5 years. Since this condition is impossible for you, we advise you to register a legal entity and employ appropriately qualified specialists on staff.

Question: As an individual entrepreneur, I can hire pediatricians and license them to provide services. Or do I need an LLC? I do not have a medical education.

Answer: I would like to note right away that you cannot license doctors, since in principle there are no provisions in the legislation that would regulate such activities. Only licensing authorities are vested with licensing functions. If you do not have a medical education, then you need to register a legal entity, for example a Limited Liability Company. In this case, you will have the opportunity to hire appropriately qualified doctors who will carry out work according to the declared types.

1. Application for a license with an appendix indicating the range of work and services for the provision of medical care (in the form).
2. Constituent documents with all amendments and additions registered in the manner prescribed by current legislation:

• Founder's decision
• Foundation agreement (if provided),
• Charter

3 . Documents for registration as a legal entity or individual entrepreneur:
For a legal entity:

• Certificate of entry into the Unified State Register of Legal Entities,
• Certificate of making an entry in the Unified State Register of Legal Entities on amendments to the constituent documents of a legal entity,
• Extract from the Unified State Register of Legal Entities

• Copy of passport,
• Certificate of entry into the Unified State Register of Individual Entrepreneurs,
• Certificate of making an entry in the Unified State Register of Entrepreneurs about changes to information about the individual entrepreneur,
• Extract from the Unified State Register of Individual Entrepreneurs

4 . Documents for registration with the Federal Tax Service:

• Certificate of registration of the license applicant with the tax authority,
• Notification of registration of the license applicant with the tax authority at the location of the territorially separate unit (branch, representative office).

5 . Documents on payment of duties (original):
6 . Information letter from the Federal State Statistics Service (Rosstat) on registration in the USRPO.
7 . Sanitary and epidemiological conclusion on compliance with sanitary rules of the work performed and services provided that constitute medical activities.
8 . Conclusion of the Federal Fire Service on compliance with fire safety requirements at the licensee’s facilities.
9 . Documents confirming the qualifications of employees of a legal entity that meet licensing requirements and conditions:
For persons with secondary vocational education:

• Diploma of secondary medical (or other, if provided) education.
• Document (certificate) of specialization corresponding to the type of activity.
• Document on the next advanced training (valid for 5 years).
• Specialist Certificate (valid for 5 years).

For persons with higher medical education:

• Diploma of higher medical education
• Document on the relevant primary specialization (internship)
• Document on in-depth specialization for narrow specialists, or
• Diploma of professional retraining.
• Specialist Certificate (valid for 5 years)

For the manager of the license applicant, in addition: a document confirming the presence of work experience in a licensed activity of at least 5 years - a work book.

For an individual entrepreneur, in addition: a document confirming the presence of work experience in a licensed activity of at least 5 years - a work book.

10 . Documents confirming that the licensee has the relevant premises legally owned by him:
By right of ownership:

• Sales and purchase agreement, commissioning certificate, etc.
• Certificate of state registration of property rights

On lease from the owner:

• Lease agreement
• Technical passport of the object with explanation
• Title documents of the lessor (purchase and sale agreement, commissioning certificate, etc.)
• Certificate of state registration of the landlord's right

On the right to lease premises located as part of a facility under operational management (economic management):

• Lease agreement agreed upon
• Certificate of state registration of lease
• Technical passport of the object with explanation
• Agreement on operational management (decision, order, resolution)
• Certificate of state registration of the right to operational management
• Extract from the register of municipal property

On the right of free use (loan):

• Agreement for free use (loan)
• Technical passport of the object with explanation
• Lender's title documents (sale and purchase agreement, lease, etc.)
• Certificate of state registration of the lender's right

11 . Documents confirming the availability of appropriate organizational and technical conditions for material and technical equipment, including equipment, tools, transport and documentation, ensuring the use of medical technologies approved for use by the Federal Service for Surveillance in Healthcare and Social Development:

• List of used medical equipment indicating wear percentage
• Maintenance contract (if under warranty - warranty service contract)
• Agreement for metrological control (if under warranty - warranty service agreement)
• License of an organization providing maintenance (warranty repairs) of medical equipment
• Accreditation certificate or license of an organization performing metrological control
• Certificate (conclusion) of the technical condition of medical equipment, indicating the extension of operation
• Certificate (conclusion) on passing verification of measuring instruments
• Certificate of Conformity
• Registration certificate

Agreements for the provision of recycling services:

• Solid waste removal
• Demercurization of mercury lamps
• Syringe disposal
• License of a contractor for hazardous waste disposal (syringes, demercurization)

Local acts of organization and individual entrepreneurs and administrative documents:

• Regulations on activities
• Staffing table (for organizations)
• Job descriptions of specialists
• Order from the manager on the appointment of the chief physician
• Order on quality control of medical care and appointment of a responsible specialist
• Agreements with medical institutions and laboratories for analysis, research, autoclaving, etc., with a license attached (if such agreements and activities exist).

Dentistry licensing

Dentistry has been and will continue to be a popular type of medical activity, since there is always a demand for the services of a dentist. Only the legal requirements for licensing dentistry are changing. To the documentation of the licensing case and the sanitary standards required for the premises where the services of a dentist are supposed to be provided.

The regulations that today determine the licensing requirements for dental services are:

1. Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens of July 22, 1993. (as amended on December 30, 2008);
2. Federal Law of August 8, 2001 “On licensing of certain types of activities” (as amended on December 30, 2008);
3. Decree of the Government of the Russian Federation of January 22, 2007. “On approval of the Regulations on licensing of medical activities”;
4. Order of the Ministry of Health and Social Development of May 10, 2007. No. 323 “On the organization of work (services) performed in the provision of pre-medical, outpatient (including primary health care, medical care for women during pregnancy, during and after childbirth, specialized medical care), inpatient (including including primary health care, medical care for women during pregnancy, during and after childbirth, specialized medical care), emergency and emergency specialized (sanitary and aviation), high-tech, sanatorium and resort medical care" (as amended on January 23, 2009 .);
5. Order of the Ministry of Health and Social Development of December 1, 2005. No. 753 “On equipping outpatient clinics and inpatient clinics in municipalities with diagnostic equipment.”
6. SanPin 2.1.3.1375-03 “Hygienic requirements for the placement, design, equipment and operation of hospitals, maternity hospitals and other medical hospitals”;
7. Sanitary rules for the design, equipment, operation of outpatient dental clinics, occupational safety and personal hygiene of personnel (approved by the Chief State Sanitary Doctor of the USSR dated December 28, 1983 No. 2956a-83);
8. Requirements for sanitary-hygienic, anti-epidemic regimes and working conditions for workers in non-state medical institutions and offices of private dental doctors (approved by the Chief State Sanitary Doctor for Moscow on October 10, 1998 No. 12/22-758)

Licensing of dental activities of a dental clinic - limited liability company

The general requirements and conditions for licensing dental activities when carrying out medical activities are:

a) the license applicant (licensee) has buildings, premises, equipment and medical equipment belonging to him by right of ownership or on another legal basis necessary to perform work (services) that meet the requirements established for them;
b) the presence of the head or deputy head of a legal entity or the head of a structural unit responsible for carrying out licensed activities - a license applicant (licensee) of higher (secondary - in the case of performing work (services) on pre-medical care) professional (medical) education, postgraduate or additional professional (medical) education and work experience in the specialty for at least 5 years;
c) the individual entrepreneur - license applicant (licensee) has a higher (secondary - in the case of performing work (services) for pre-medical care) professional (medical) education, postgraduate or additional professional (medical) education and work experience in the specialty of at least 5 years ;
d) the presence on the staff of the license applicant (licensee) or the hiring by him on another legal basis of specialists necessary to perform work (services) who have a higher or secondary vocational (medical) education and a specialist certificate that meets the requirements and nature of the work (services) performed;
e) advanced training of specialists performing work (services) at least once every 5 years;
f) compliance by the licensee with medical technologies when carrying out medical activities, permitted for use in the manner established by the legislation of the Russian Federation;
g) compliance by the licensee with sanitary rules when carrying out medical activities;
h) ensuring the licensee, when carrying out medical activities, monitors the compliance of the quality of performed medical work (services) with the established requirements (standards);
i) compliance by the licensee with the rules for the provision of paid medical services approved in the prescribed manner;
j) the presence on the staff of the license applicant (licensee) of specialists performing technical maintenance of medical equipment, or the presence of an agreement with an organization licensed to carry out this type of activity;
k) maintenance by the licensee of accounting and reporting medical documentation when carrying out medical activities.

Licensing of dental activities of an individual entrepreneur

Regarding the implementation of dental practice individual entrepreneur In terms of licensing of dental activities, the Law provides for significant restrictions.

An individual entrepreneur is obliged to provide dental services personally and does not have the right to hire other specialists. The justification for this is contained in clause 1 of article 7 of the Federal Law of 08.08.2001. No. 128-FZ “On licensing of certain types of activities”, according to which the type of activity for which a license has been granted can only be carried out by a licensed legal entity or individual entrepreneur.

In addition, the Decree of the Government of the Russian Federation “On approval of the Regulations on licensing of medical activities” dated January 22, 2007 No. 30 obliges an individual entrepreneur to have at least 5 years of experience in the declared type of medical activity (in particular, in this case, the provision of dental services).

Licensing of dental activities in the field of implantology

Currently, the direction has become widespread implantology– a relatively new direction in dentistry, which allows the patient’s teeth to be restored using artificial roots. Many people are now thinking about introducing this area into their dental practice.

This type of medical service is now in demand, but in order to practice it, you need to apply for an application to your current license.

In this case, you will need to increase your own or rented space:
Thus, sanitary rules when introducing implantology provide for the following additional areas:

1. 24 sq.m. for a small operating room;
2. 8 sq.m. for preoperative room;
3. 2 sq.m – gateway;
4. 10 sq.m – ward for temporary stay of the patient after surgery.

And the following types of activities must be added to the medical license of a dental clinic:

– surgical dentistry;
- anesthesiology (reanimatology).

In addition, the organization must have a dental surgeon on staff with a certificate of advanced training in implantology.

Licensing of dental activities - x-ray room services

Availability in medical license radiology serves as a good source of profit for the dental clinic and allows for the provision of comprehensive dental services. But the procedure for obtaining permits for this type of activity is complex and lengthy. Obtaining permits is carried out in several stages:

1. The placement of X-ray machines in X-ray rooms is carried out on the basis of the project. The development of the project is carried out by a design organization that has a license for the relevant type of activity, based on the Customer’s technical specifications. A sanitary and epidemiological report is issued for the project in the prescribed manner;
2. Registration of a sanitary and epidemiological certificate (hereinafter - SEZ) for the right to operate an X-ray machine;
3. SEZ for medical activities – radiology;
4. License for medical activities – radiology;
5. License to carry out activities with a source of ionizing radiation.