An organization that deals with dental licensing. License for dental activities. What documents are needed

If you decide to open your own clinic, remember that dental licensing– a prerequisite for successful work.

In what areas is dentistry licensing required?

A license is required for the following areas of dentistry.

1. Pediatric dentistry, licensing for which is mandatory. It is a special direction in dentistry. To provide services in this industry, a specialist needs to know both the characteristics of the child’s body and the child’s psychology.
2. Orthopedic dentistry. The main task of an orthopedic dentist is to replace lost teeth from a functional and aesthetic point of view, to prevent traumatic effects on them, as well as on the gums and bone tissue.
3. Preventive dentistry. It consists of a set of preventive measures against the occurrence of caries and gum disease.
4. Therapeutic dentistry. Specialists in this industry treat carious formations in all forms.
5. Surgical dentistry. Dental surgeons remove teeth and perform various operations, if odontogenic abscesses, periodontitis or periostitis are diagnosed in patients.
6. Dentistry general practice. Often one doctor, registered as an individual entrepreneur, provides services in this area independently. General dentistry, for which licensing is also required, covers all types of services listed earlier.

What is regulated by dental licensing?

Licensing of dentistry presupposes the presence of such regulatory documents, How:

The document contains information:

• about the requirements for dentistry of all types.
• about the offices that you must have in order to obtain licensing for medical activities (dentistry in this case).
• about the medical personnel who need to be hired to work in dentistry and the number of employees.
• on the requirements for equipment for dentistry.

Resolution of May 18, 2010 No. 58“On approval of SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities.”

The document describes the requirements for the following parameters:

• area of ​​dental offices, sterilization, operating rooms and other premises;
• dental repair;
• ventilation, lighting.

Order of the Ministry of Health and Social Development of the Russian Federation of July 7, 2009 N 415n“On approval of qualification requirements for specialists with higher and postgraduate medical and pharmaceutical education in the field of healthcare.” This document describes the requirements that apply to all dental medical personnel.

What are the dental licensing requirements?

Licensing requirements are a set of requirements that are stated in the provisions on licensing of certain types of activities. The basis of licensing requirements is the requirements of the current legislation of the Russian Federation. The main objective of licensing requirements is to ensure the achievement of licensing goals (in accordance with paragraph 7 of Article 3 of Law No. 99-FZ).

Requirements for the presence of buildings or premises

Medical institutions are required to have structures, buildings, structures and (or) premises that are owned or for other legal reasons. Another legal basis is the right to rent. To confirm it, present the concluded lease agreement for dentistry or premises for other purposes. In addition, medical institutions may have real estate assets under operational management rights. As confirmation in this case, a certificate of state registration of the relevant right is presented.

Premises requirements

The first is the requirements of SanPiN, which are stated in the Resolution of the Chief State Sanitary Doctor of Russia dated May 18, 2010 No. 58 “On approval of SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities.”

The second is the requirements for the procedure for providing medical care, which speak, in particular, about the standards for equipping premises for the provision of certain types of medical services.

Requirements for medical devices

An entrepreneur who is interested in licensing dentistry proves that he has the medical products (devices, equipment, devices, instruments) necessary to carry out certain work or provide services on a legal basis. He confirms ownership of these products with relevant documents and agreements (invoices, supply agreements, balance sheets etc.). It is also possible to rent medical products.

When talking about medical products, according to paragraph 1 of Art. 28 of Law No. 323-FZ, mean any types of devices, tools, equipment, materials, as well as special software. All this is used in diagnostic, preventive, medicinal purposes(in accordance with the manufacturer's instructions), as well as for medical rehabilitation diseases, assessing the condition of the patient’s body, during research, as well as restoration, replacement, change anatomical structure or physiological functions of the body, termination or prevention of pregnancy. These medical products do not have an immunological, pharmacological, metabolic or genetic effect on the body.

Requirements for state registration of medical devices

An entrepreneur who is interested in dental licensing is also required to provide data on state registration of products medical purposes(these are tools and devices, equipment and devices necessary to carry out the declared work or provide services).

In Russia, the circulation of medical devices that are registered in the prescribed manner is allowed in accordance with the Decree of the Government of Russia of December 27, 2012 No. 1416 “On approval of the Rules for state registration of medical devices.” State registration of medical devices is carried out by the Federal Law on supervision in the field of healthcare. To confirm the presence of state registration for certain medical products, presentation of the appropriate registration certificate is required. The form of the certificate is approved by the registration authority. The validity of the certificate does not expire.

State registration is not required only for medical devices that are manufactured in accordance with individual patient orders. Such medical devices must be created by certain medical professionals, who are subject to special requirements. Medical products can only be used by the patient.

Requirements for qualifications of management personnel

The regulations on licensing of medical activities (dentists and other institutions) speak about the educational requirements for the head of a medical institution, his deputies responsible for conducting medical activities, and the head of a structural department of another institution responsible for medical activities.

Let us note that the head of a medical institution can be not only the chief physician, but also other persons in leadership positions, in accordance with Order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1183n “On approval of the Nomenclature of Positions medical work nicks and pharmaceutical workers."

Came into force on January 1, 2016. According to it, replacing a specialist’s certificate with a certificate of accreditation of a health worker has become possible.

The legislation also talks about a transition period. Thus, in accordance with Part 1.1 of Law No. 323-FZ, the transition to the procedure for accreditation of specialists is gradual, from January 1, 2016 to December 31, 2025 inclusive. The Order of the Ministry of Health of Russia dated February 25, 2016 No. 127n mentions the terms and stages of accreditation of specialists. The document also talks about categories of persons with medical, pharmaceutical or other education, as well as specialists subject to accreditation. In accordance with this act, in 2016 graduates in the fields of “Pharmacy” and “Dentistry” are subject to accreditation, in 2017 – graduates in the specialties “General Medicine”, “Medical and Preventive Care”, “Pediatrics”. In 2026, all workers in the field of medicine and pharmaceuticals must undergo accreditation.

Specialist certificates issued to health workers before January 1, 2021 are valid until the end of the period indicated therein.

Requirements for work experience in the specialty for managers

For licensing purposes, heads of medical institutions, their deputies, managers structural departments and individual entrepreneurs must confirm work experience in their specialty, which is at least five years. Mandatory requirement The requirement for specialists is to have a higher medical education. Note that if an individual entrepreneur has a secondary medical education, his work experience must be at least three years, which is a reduction in requirements.

Requirements for the availability of staff units and their qualifications

A specialist who is interested in licensing dentistry must confirm that the employees who have entered into an agreement with him employment contract, have secondary, higher, postgraduate and (or) additional medical education. This is necessary to provide the stated services or carry out certain work. Employees of a medical institution must also have specialist certificates (if we are talking about employees with medical education).

Requirements for the qualifications of medical personnel

The qualification requirements and characteristics of medical personnel for work in certain positions are stated in:

• Order of the Ministry of Health of Russia dated October 8, 2015 No. 707n “On approval of qualification requirements for medical and pharmaceutical workers with higher education in the field of preparation “Health and Medical Sciences”.
• section “Qualification characteristics of positions of workers in the healthcare sector” of the “Unified Qualification Directory of Positions of Managers, Specialists and Employees”, which was approved by Order of the Ministry of Health and Social Development of the Russian Federation dated July 23, 2010 No. 541n. The document talks about qualification characteristics ah for certain positions of employees with higher medical education.
• Order of the USSR Ministry of Health dated July 21, 1988 No. 579 “On approval of the qualification characteristics of medical specialists.”

In accordance with Russian legislation, persons with incomplete higher medical education can hold positions as nursing staff. The conditions and procedure for their admission are stated in the Order of the Ministry of Health and Social Development of Russia dated March 19, 2012 No. 239n.

Requirements for job titles and staffing

Medical institutions are subject to fairly strict requirements. In this regard, arbitrary job titles should not be allowed. The Order of the Ministry of Health of Russia dated December 20, 2012 No. 1183n talks about the “Nomenclature of positions for medical workers and pharmaceutical workers.”

The establishment of the names of positions of medical specialists and other health workers is carried out in accordance with the names of specialties, the nomenclature of which is approved by law (Order of the Ministry of Health of Russia dated October 7, 2015 No. 700n, Order of the Ministry of Health and Social Development of the Russian Federation dated April 16, 2008 No. 176n).

The establishment of staffing standards for medical staff and other employees of the institution is carried out in accordance with the procedure for providing medical care. Such standards are mandatory only for government agencies working in the healthcare sector. As for other cases, the nature of these standards here is advisory.

Requirements for the system of internal quality control and safety of medical activities

An important licensing requirement for those who wish to obtain a license to practice medicine is: internal control over the quality and safety of medical activities in the institution. At the moment, there is, unfortunately, no exact regulatory answer to the question of how such a system of internal control over the quality and safety of medical activities should be organized.

Article 87 (Part 2) of the Law talks about ways to implement quality control and safety of activities in the medical industry, as well as in various ways accounting and control of the work of medical institutions, including through the creation of a system for assessing the activities of health workers involved in the provision of medical services.

At the moment, the main document in the healthcare sector on supervision in the field of control over the quality and safety of medical activities is the Resolution Russian Government dated November 12, 2012 No. 1152 “On approval of the Regulations on state control of the quality and safety of medical activities.” This document provides information on the requirements for businesses operating in the medical industry. In accordance with the Resolution, organizations should maintain internal control over the quality of medical activities. However, there is no clear guidance for action in the Resolution.

What documents are required for dental licensing?

Licensing of dentistry implies the presence of:

1. Constituent documents: charter, constituent agreement, protocol, regulations, decision on the creation of an enterprise, appointment of a director; protocol of the founders or a decision to make changes (if it is planned to make any changes to the constituent documentation).
2. Registration documents: certificates of state registration as a legal entity; certificates of amendments (if changes are made to the constituent documentation); tax registration certificate.
3. Goskomstat codes.
4. A sanitary and epidemiological conclusion that the services provided and work performed in dentistry comply with sanitary standards and rules. If there are separate facilities, sanitary and epidemiological certificates must be issued for them as well.
5. Documents that confirm that the qualifications of employees medical institution does not contradict the requirements and conditions for dental licensing: a diploma of secondary or higher medical education; certificate; work book; marriage certificate (if the last name has changed).
6. Documents that confirm that the qualifications of the head of the legal entity and (or) the person authorized by him meet the requirements and conditions for licensing: a diploma of higher medical education; certificate, certificate of advanced training; a work book confirming at least five years of work experience in the dental industry; marriage certificate (if the last name has changed).
7. Documents that confirm that the premises for medical activities are owned or in accordance with another legal basis: lease agreement; certificates of ownership; BTI floor plan with explication.
8. Documents that confirm that the appropriate organizational and technical conditions for material and technical equipment have been created in dentistry. At the same time, the entire range of tools, equipment, as well as transport and documents ensure the use of medical technologies, which are authorized for use by the Federal Law on supervision in the field of healthcare and social development (this includes the list of used medical equipment, which indicates the percentage of wear, a maintenance agreement with a company that provides maintenance of medical equipment about the license of the organization responsible for maintenance medical equipment, on the certificate of technical condition of medical equipment).
9. Expert opinion of the Federal State Institution at Federal service health and social development.
10. A document that confirms the fact of payment of the license fee (the cost of processing the application is 7,500 rubles).
11. Powers of attorney (if you are applying to a law firm).

Which bodies carry out licensing of dentistry?

Licensing of medical activities (dentistry) can be carried out (in accordance with clause 2 of the Regulations on licensing of medical activities):

• Federal Law on supervision in the field of healthcare (Roszdravnadzor);
• executive authorities of the constituent entities of the Russian Federation.

Information about a specific executive body of a constituent entity of the Russian Federation that is involved in licensing medical activities contains regulations subjects of the Russian Federation. Executive authorities are different for each subject.

Stages of dental licensing

Filing an application

Where does dental licensing begin? The applicant submits an application to the dental licensing authority. The application for permission is drawn up in the approved form. It is also accompanied by documents that are mentioned in the regulations on licensing of certain types of activities.

Do not forget about the requirements and conditions under which licensing of dentistry is possible. Since it is one of the forms of security control, there is a close connection between the conditions and requirements for licensing with control over whether a particular company meets security requirements in its work.

When submitting an application, a legal entity or a person who has registered an individual entrepreneur (dentistry, licensing - these issues are key) must demonstrate that it has the necessary premises for carrying out medical activities, personnel, qualified specialists capable of ensuring a sufficient level of safety when providing certain services or carrying out works All documentation in dentistry must comply with the requirements of SanPiN, GOST, SNiP, legislation and regulations. Only in this case will licensing of dentistry be successful.

Verifying compliance with license requirements and conditions

The check can be:

• formal (simple verification of documentation).
• actual (the process of inspecting a legal entity that has submitted an application for dental licensing).

The body that is contacted for licensing dentistry has the right to inspect the premises and equipment, find out whether it really exists, or whether its existence is only stated in the documentation.

Making a decision to issue a license.

The government agency evaluates how dentistry meets licensing requirements and decides whether to issue a license or not. In this case, the government agency looks at how well the documents are completed and whether they comply with the requirements established at the legislative level.

Issuance of a license

You are given a document that states a certain period. During this period of time, you can provide services for which permission has been obtained. When the period expires, you will not need to collect documents for dental licensing again. It is possible to extend the validity period of the license, since it is unlimited.

In what cases is licensing of dentistry impossible?

The body that carries out licensing of dentistry has the opportunity to issue a license within no more than thirty days from the date of receipt of the application and all necessary documentation. The body that carries out this procedure may also give a negative answer. He is obliged to inform the applicant about the decision within three days from the date of its adoption.

When sending the applicant a notice of issuance of a permit, the licensing authority indicates the bank account details for payment of the fee, as well as the payment deadline. The license is issued within three days from the day the applicant provided a document confirming payment of the fee.

If medical activities are carried out at facilities that are geographically isolated from each other, certified copies of it are issued along with the license, which indicate the address of the location of the facilities. Issuing copies of documents is free.

If the dental licensing authority refuses to issue a permit, the reason for the refusal shall be indicated in the notice of refusal. The grounds for refusal may be as follows:

• the documentation submitted by the license applicant contains false information or distorted information;
• the license applicant does not meet the conditions and requirements under which dental licensing can be successfully completed.

If the licensing authority gives a negative answer, the application fee is not refunded. The applicant can appeal the inaction of the body or its refusal in accordance with the legislation of the Russian Federation.

If an applicant decides to administratively appeal the body’s refusal to license dentistry, he can conduct an independent examination by sending a written request and paying for it himself. For this purpose, licensing authorities (in agreement with the applicant) attract independent experts and specialized organizations. Within three days, the licensing authority reviews the results of the independent examination, decides to issue a permit or refuses. He informs the applicant about his decision.

Please note that if previously an applicant (legal entity or entrepreneur) conducted medical activities without a license, and has now applied for one, the dental licensing authority may refuse to issue it, guided by Article 10 of the Federal Law “On Licensing” individual species activities." Based on this article, the reason for making a negative decision is the applicant’s non-compliance with the conditions and requirements of licensing.

A mandatory requirement and condition for licensing, in accordance with Article 9 of the same Federal Law, is strict adherence to Russian legislation, sanitary-epidemiological, environmental, hygienic, fire safety standards and rules on the part of license applicants, as well as provisions on licensing of specific types of activities.

In this regard, the licensing authority may not issue a license to a person who previously conducted medical activities without one. This contradicts the requirements of the legislation on licensing of certain types of activities.

What are the stages of licensing an X-ray room in dentistry?

Stage 1.Creation of an X-ray room

An X-ray room in dentistry is created in several stages.

1. Choosing a suitable X-ray machine for dentistry.
2. Selecting a company responsible for the implementation of this technology.
3. Selecting a room in which to place an X-ray machine (the composition and area of ​​X-ray rooms in dentistry can be found in Table No. 9.2 of SanPiN 2.6.1.1192-03).

Whether it is possible to place an X-ray machine in dentistry, you should find out from the territorial department of Rospotrebnadzor. Another option is to contact a design company that has sufficient experience in the placement of x-ray equipment.

The seller is required to present (clause 9.7 SanPiN 2.6.1.1192-03):

• sanitary-epidemiological report on the source ionizing radiation,
• registration certificate of the Ministry of Health of the Russian Federation.

Pay for the X-ray machine only after studying this documentation. Please note that the documents must be valid, with a reserve period of at least 68 months, so that it is possible to prepare the dental office for licensing without haste.

It is very important that the sanitary-epidemiological conclusion does not contain information about the prohibition of placing the device in specific conditions. In the future, due to any prohibitions, you will probably not be able to use this equipment on the territory of, for example, a residential building, or for other purposes.

Stage 2.Designing the placement of an X-ray machine in the selected room

At this stage, it is important to carry out high-quality preparation of the dental office: calculate the protection of the floor and walls, the ceiling of the room from ionizing radiation (IR), determine ergonomics: choose the most optimal option for placing the dental apparatus, decide on the location of the sink, X-ray protective screen, calculate how much is needed buy individual means protection, choose the width of passages for employees. At the design stage, calculations are also made of the air exchange rate, electrical grounding, lighting in the office and other parameters.

It is important to arrange an x-ray room in dentistry in strict accordance with the project. Only in this case can you provide your dental staff with comfort and safety at work.

Many people are interested in installing X-ray machines in dentistry located in residential buildings. Today it is real. In clause 9.2. SanPiN 2.6.1.119203 states that only dental devices and pantomographs with a highly sensitive digital image receiver can be placed. The operating load level should not exceed 40 mA x min/week.

An important addition: when operating the device, you must strictly comply with the requirements and radiation safety standards for citizens and dental employees. Safety in this case can be ensured only by installing the device in accordance with the design for placing an ionizing radiation source (IRS).

Stage 3.Repair of premises and installation of equipment in strict accordance with design materials

It is necessary to have a hidden work certificate from the construction company that laid the materials for X-ray protection. When the dental office is inspected and checked by the Rospotrebnadzor commission, you will be required to present this document.

It is worth remembering that the company that installed the dental apparatus must have a license to carry out installation work and maintain medical equipment for x-rays at both the federal and regional levels. The company must submit an installation certificate and a maintenance agreement, as well as a certificate of technical condition of the device.

Stage 4.Registration of a technical passport for the office

Contact an accredited laboratory, whose specialists will be able to assess the radiation and non-radiation factors of the working environment in the X-ray room, followed by drawing up protocols:

1. Electrical safety (clause 10.21 SanPiN 2.6.1.119203).
2. Air exchange rates (clause 10.21 SanPiN 2.6.1.119203).
3. Illumination (clause 10.21 SanPiN 2.6.1.119203).
4. Dosimetric monitoring (Appendices No. 7, No. 11 SanPiN 2.6.1.119203).
5. Operating parameters of the X-ray machine (Appendices No. 7, No. 10 SanPiN 2.6.1.119203).
6. Funds checks personal protection(Appendix No. 7 SanPiN 2.6.1.119203).

Stage 5.Training

After a successful solution technical issues take care of organizational and legal issues. The most important of these is the training of dental employees.

As an example, let's take dentistry, in which the X-ray room operates 30 hours a week (one shift). If the work in your organization is based on the same principle, you should definitely involve an x-ray laboratory assistant and a radiologist in dentistry.

You can undergo training in the field of “radiology” in specialized educational institutions for advanced training. At the same time, training of a radiologist cannot be carried out on the basis of specialization in dentistry: this is possible only for general practitioners.

Please note that it is necessary to appoint a person responsible for radiation safety in dentistry. This responsibility can be assigned to a representative of the dental administration, for example the director or chief physician. To do this, a specialist must be trained in radiation safety at one of the accredited institutions.

When specialists undergo training, the x-ray laboratory assistant and radiologist, in accordance with the order, are classified as A-group employees. This work can be performed by specialists without any medical contraindications to use X-ray machines and only after undergoing training and testing knowledge of safety precautions in dentistry (clause 9.13 of SanPiN 2.6.1.119203).

Stage 6.Preparation of documentation according to requirements

It is required to bring all dental documentation that relates to the x-ray room into compliance with Appendix No. 7 (SanPiN 2.6.1.119203).

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 - 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 specified in Labor Code RF.

Licensing of dental activities is responsible and important event before starting your own 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 for 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.

Price dental license(including x-ray room) from 45,000 rubles.

A license for medical activities is required if you open a small clinic (dental office) or dentistry (dental clinic) with a full range of services.

If you want to quickly enter the dental market, which is currently one of the most popular, promising and highly profitable, then you need to obtain a medical license as soon as possible. dental services.

Dentistry licensing The process is very labor-intensive and if you decide on this issue yourself, the process of obtaining a license can take up to one year.

Our specialists will take care of visiting all the necessary authorities and the hassle of preparing the entire package of documents. We are the only ones who give 100% license receipt in 45 days.

Today, a modern dental clinic cannot do without the use of an X-ray machine. If you plan to use an x-ray machine, then it is necessary to include x-ray licensing as part of the licensing of dental services. This procedure is very specific and this procedure units of companies are taken. As a result, the licensing process drags on for years. Therefore, it is important to entrust licensing of dental activities to professionals in this field.

What documents must be provided to obtain a dental license:

1. Constituent documents: INN, OGRN, charter, organization card, certificate of ownership of the premises, lease agreement with an act of acceptance of the transfer of the premises, certificate of state registration of the organization, extract from the Unified State Register of Legal Entities.
2. Positive conclusion of Rospotrebnadzor (conclusion of the SEZ) on the premises for the declared types of activities.
3. Documents on the education of medical personnel (diploma of medical education, internship/residency, certificates, certificates of advanced training, diplomas of professional retraining, diploma inserts, passport).
4. Documents for equipment and furniture (invoices, registration certificates for furniture and equipment). All equipment and furniture must have Registration Certificates.
5. Contract for maintenance of medical equipment. Medical equipment must be supplied for maintenance by an organization that has a license for the maintenance of medical equipment.
6. The state fee paid is 7,500 rubles for issuing a license, 3,500 rubles for re-issuing a license. The state duty must be paid from the organization's current account.

How to obtain a dental license?

To obtain a license to practice dentistry, it is enough to:

1. Arrange a meeting at our Center or at your site
2. Provide us with a copy of the floor plan and constituent documents
3. Conclude an agreement with us
4. We will do all the rest of the work for you!

A dental license is issued for an indefinite period!

The Unified Center for Medical Licensing guarantees obtaining an X-ray license faster than anyone else in the city. Our specialists will be able to carry out the entire cycle of work to prepare the premises for the X-ray room: they will develop a project, make repairs, receive laboratory research. They will also receive two final studies from Rospotrebnadzor: on the source of ionizing radiation, as well as a medical report on radiology in dentistry.

Dentistry licensing

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

1. Fundamentals of legislation Russian Federation on the protection of citizens' health dated 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 dated May 10, 2007 No. 323 “On the organization of work (services) performed in the implementation of pre-medical, outpatient and polyclinic (including primary health care, medical care women during pregnancy, during and after childbirth, specialized medical care), hospital (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 and 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

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 first aid) professional (medical) education, postgraduate or additional professional (medical) education and work experience in the specialty of 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 involvement 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 engaged in the 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

An individual entrepreneur is obliged to provide dental services personally and does not have the right to hire other specialists. The rationale for this is contained in clause 1 of article 7 Federal Law from 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 those who have received the license legal entity or an 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

This kind medical services 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 – patient’s temporary stay room after surgery.

– surgical dentistry;
- anesthesiology (reanimatology).

Licensing of dental activities - x-ray room services

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.