Licensing of dentistry: requirements, documents and procedure for obtaining a license. Licensing of dental activities Do I need a license for general practice dentistry
Definition of the "Cabinet" format among other forms of doing this business, step-by-step instructions for opening a dental office and what is needed for this.
Dentistry has always been a highly profitable business. According to analysts, work in this area can bring the greatest income to doctors, not to mention the owners of the enterprise. It is not for nothing that the faculties of this direction in medical universities are considered the most prestigious, we will consider the procedure for opening a dental office, where to start, which format to choose.
Forms of providing dental services
There are only 3 types of organizations in this market:
1. State and departmental dentistry. They exist on state subsidies, while providing additional paid services. Serve the underprivileged. They are a forge of personnel for private dentistry.
2. Private dental clinics. There can be "VIP", "middle class" and "economy" depending on the level of equipment, interior decoration, staff qualifications. Average size 200 - 250 sq. m., designed for approximately 10-15 dental units. These are the most visited, highly profitable enterprises. The average monthly revenue is $30-50 thousand, and the net profit is $15-20 thousand.
In addition to regular customers "from the outside", people come to them under the contracts of insurance companies. This demand is largely due to the wide range of dental services that they are ready to provide, namely:
- consultations, functional diagnostics, X-ray;
- therapeutic dentistry (treatment of pulpitis, caries, etc.);
- periodontics (treatment of gingivitis and other diseases of the gums, bone tissue, etc.);
- surgical dentistry (treatment of purulent diseases, extraction of teeth, excision of benign tumors, etc.). Physiotherapy and anesthesia are attached to this direction;
- hygienic (preventive) dentistry (teeth whitening, removal of plaque, tartar, etc.);
- orthopedic dentistry (dental prosthetics);
- orthodontics (bite correction, etc.);
- implantology (restoration of teeth based on artificial roots);
- children's dentistry.
3. Private dental offices. These are small premises (30 - 80 sq.m.), equipped with 1-2 dental units. As a rule, the range of services is much narrower than in clinics. After all, 1-2 working points are not able to serve several specialists at once - a periodontist, surgeon, orthopedist, etc.
It is also rare to find a human orchestra with all dental specialties. To do this, he must have a whole set of relevant certificates and diplomas, and also have a separate license for each type of activity. Therefore, offices are not as in demand as clinics.: people prefer to receive complex treatment in one place. Accordingly, their income will be less. Basically, the clients of such organizations are people who applied for a specific one-time service, and are also ready to suffer inconvenience, if only to be treated by a specialist they like.
Thus, the undisputed leaders of the dental services market are private general clinics. It is they who are able to bring the greatest income to their owners, although the initial costs will be very significant - from 5 million rubles. If there are not enough funds to open such an institution, you can start by organizing a dental office, setting aside about 1.5 - 2.5 million rubles for the start. What is needed for this, we will consider further.
Registration
1 If you have the appropriate education and experience and plan to carry out all the manipulations on your own, then you can register with the tax office as an individual entrepreneur. After all, a license to carry out medical activities is issued only to a specific individual. If you are not a practitioner, then the only option is to open an LLC. In this case, the license will have to be issued for employees whose education and experience meet the licensing conditions.
2 To open a dental office, you will need to indicate such OKVED codes as:
- 85.12 Medical practice
- 85.13 Dental practice
3 Next, you need to register with the Pension Fund, the Compulsory Medical Insurance Fund, the Social Insurance Fund, start a book of income and expenses, open an account and order a seal.
4 Then you need to purchase a KKM (cash register), register a cashier's magazine in the tax office and conclude an agreement for servicing the device.
Selection and preparation of premises for dentistry
Before proceeding with the selection of premises, it is advisable to have a detailed business plan on hand. It is necessary to clearly understand how the office will be planned, how and what will be located there, etc. It is also important that the room meets the requirements stated in the following standards:
Sometimes in the regions additional regulatory legal acts regulating this issue are developed.
Rospotrebnadzor imposes particularly stringent requirements on dental office space. It is 14 sq. m for 1 dental unit and plus 7 sq. for each subsequent one. Thus to open the simplest office for one workplace, you need the area of \u200b\u200bone typical apartment(about 3o sq. m). In addition to taking into account the dimensions of the installation, it should include the area of \u200b\u200bthe hall (10 sq. M) and the bathroom (5 sq. M).
If you plan to expand your business in the future, we recommend that you calculate the area based on the following averages:
- sterilization room - 6 sq. m (needed only where there are 3 or more dental units);
- X-ray room - 11 sq. m plus 5-6 sq. m under the processing room;
- office of orthopedics and orthodontics - 15 sq. m;
- implantology room, children's room, etc. - 15 sq. m for each;
- auxiliary premises (warehouse, sterilization room, toilet, administration and staff rooms 30-40 sq. meters.
It is desirable that there should be no more than one chair in each office. Patients value closeness and comfort. The height of the ceilings in the office is allowed not less than 3 m, the depth - not more than 6 m (with one-sided daylight).
A dental office can be opened both in a residential area and in a business area. The main thing is that it is located close to bus stops, preferably on the 1st floor, and the rental fee is acceptable. However Renting is not the best option. Firstly, it is very difficult to find a ready-made room that meets all Sanpin standards. Most likely, you will have to completely reschedule it and spend a lot of money on it. In addition, a medical license is issued to carry out activities in a specific room, as well as permits from the SES and Rospozhnadzor. If the landlord does not want to renew the contract with you, you will have to go through everything all over again. And for 2 years of work, you will pay him an amount equal to the cost of the entire premises.
If you have enough money, the ideal option would be purchase of premises for dentistry in the property. If this is a housing stock, then it must be transferred to non-residential. You will also have to order projects for the premises: technological, architectural, power supply, sewerage and water supply, sometimes ventilation. Project documentation must be agreed with:
- bodies of the State Fire Supervision;
- TU Rospotrebnadzor;
- Architectural and Planning Department;
- State Expertise;
Requires special repairs: the dental chair must be connected to electricity, water, sewage, that is, the whole system will have to be laid under the floor. Need special ventilation, alarm and much more. On average, repairs will cost $ 250 per square meter. meter.
Equipment
When choosing and installing equipment, you must be guided by:
The purchase of medical equipment is the most costly item of expenditure. Below is a rough estimate of what you will need:
Basic equipment
Additional specialized equipment and equipment
| Instruments | Price, euro |
| Set of tools, Total: | |
| including: | |
| Set of tweezers | |
| Micromotor handpieces (2 pcs.) | |
| A set of curettage spoons. | |
| Turbine tips (2 pcs.) | |
| Gingival scissors set | |
| Set of burs, needles, syringes | |
| Hooks, heads and more | |
| Additional equipment, incl. | |
| Autoclave | |
| MECTRON LED curing lamp with hose | |
| Sterilizer | |
| Ultrasonic scanner for removing stones and plaque | |
| X-ray unit, mobile on a stand | |
| Fridge | |
| Ultraviolet chamber for storing sterile instruments | |
| Doctor's table |
Staff
Those specialists should be invited to work, education which corresponds to the areas of work of the dental office. So, if it is planned to provide therapeutic dentistry services, then it is necessary to invite a dentist with certificate in therapeutic dentistry, diploma about the internship and residency and experience work for at least 5 years. The presence of such an employee in the state allows you to issue a medical license. And so - in all areas, for each of which you will need to obtain a separate license (for surgery, orthodontics, etc.).
Some activities may be carried out nursing staff. For example, to provide services in hygienic dentistry. To do this, a physician must have a secondary vocational education and a certificate in the specialization "Preventive Dentistry". Also, paramedical personnel should assist dentists. These people need to be certified as a Nurse in Dentistry, or simply as a Nurse, but with experience in dentistry.
According to the regulations, the work of one dentist by duration cannot exceed 6 hours per day. The same applies to nurses. The staff of specialists should be planned based on these indicators. At a minimum, you need to hire 2 dentists, 2 nurses, a nurse and one administrator.
Issuance of permits
Registration of the conclusion of Rospotrebnadzor, permits of the State Fire Supervision Service and a medical license
When the premises are put into operation, the staff is formed, it's time to move on to the next stage - obtaining the conclusion of Rospotrebnadzor, decisions of the Fire Supervision, and then to obtaining a license.
Rospotrebnadzor provides:
- Statement
- Passport
- Certificate of registration as a legal or physical. faces.
- TIN certificate
- Extract from USRN
- Certificate of ownership or lease agreement for premises
- Explication
- BTI plan
- Contracts for laundry, garbage collection, destruction of fluorescent lamps, disinfection, deratization and disinfestation
- Examinations (water, air, physical factors, washings for sterility)
- Honey. books and a contract for honey. employee inspection
- Measurements of illumination, microclimate
If the office is organized in a new place, then first you need to get a sanitary and epidemiological conclusion on the placement, only then - a sanitary and epidemiological conclusion on the conformity of services and works.
The following must be submitted to the State Supervision Authority:
- St. TIN
- Lease agreement or certificate of ownership
- St. about passed. fire fighting courses security
- Fire order. security
- Instructions, evacuation plan
- Papers confirming the presence of an alarm and a fire extinguisher
- Resistance measurement protocol
Obtaining a license
Roszdravnadzor must provide documents in accordance with the Fed. Law "On Licensing" of 04.05.2011 N 99-FZ and Resolution of 16 April. 2012 N 291. Each type of medical activity must be licensed separately.
Those who have professional experience in the field of dentistry sooner or later think about opening their own personal dental office. However, it is important to do so in accordance with all laws and regulations set by the government. To take this important step, it is important to research a variety of points in advance, for example, to find out:
- various subtleties and nuances of this case, which are important to consider;
- what documents are required, how to get a license;
- difficulties that may occur during registration;
- how long the license is valid for;
- what awaits those who work without a license.
If all these factors are thought out, then it will be much easier to bring a business idea to life. However, it is important to remember that obtaining a permit is almost the final step in starting your own business. Before going for a license, you should choose a room for a future office and purchase equipment for it, as well as hire all the necessary employees.
About licensing: some nuances
If a citizen independently opened a dental office without taking care of obtaining the appropriate license, then sooner or later an inspection will come to him and, having discovered this detail, he will definitely impose a rather big fine. At the same time, the doctor will not be able to continue to carry out his activities - he will be obliged to either close the office or acquire a permit. In addition, the presence of such a document can become a guarantee for your customers that you are really a professional and your activities are legal.
Dentistry has several branches. Here are the most basic ones:
- general;
- children's;
- orthodontics;
- surgical;
- therapeutic;
- orthopedic;
- x-ray;
- prosthetics;
- preventive.
Each category requires a separate license. They belong to small businesses and do not lose their relevance - people always need to treat their teeth. In addition, there are procedures such as teeth whitening or brushing, many visit dentists for prevention. In any case, opening a dental office is a profitable investment.
Order and design
So, what steps do you need to take to obtain a license?
First, you need to decide where you need to apply.. There are two options - you can go to the federal supervision service or to the territorial authorities. It is also important to take into account that individuals apply at the place of registration, and legal entities - at the place of registration of the organization. For the first time, a citizen who has come receives an exact list of all the documents that need to be collected (in different regions they may differ slightly).
The second step is the collection and submission of documents. Here is a list of required documents for licensing a dental office:
- an identity document (for an individual - a passport and TIN; for a legal entity - TIN, an extract from the Unified State Register of Legal Entities and constituent documents);
- paper, which will confirm the availability of premises for the office and all the necessary equipment, which must be documented, contracts for maintenance;
- diplomas of graduation from the relevant educational institutions of each of the clinic employees, certificates of completed advanced training courses, a certificate confirming work experience of at least five years, concluded contracts with staff;
- a work permit from Rospotrebnadzor, a receipt confirming the payment of the state duty (the amount is about 7,500 rubles) and an inventory of all the documents provided;
- Correctly executed and completed application for a medical license. It should include the following factors:
- Passport details of the citizen applying for the license.
- Name of individual entrepreneur, organization, place of registration and actual address.
- A document confirming the entry of a legal entity or individual entrepreneur into the register, data of the organization that carried out this procedure.
- Taxpayer identification number and information on registration with the tax service.
- Description of the entrepreneur's activities, a paper confirming the payment of the state duty.
- Description of attached documents.
The application must be written without errors and blots. In addition, this document and others must not contain false information, otherwise the violator will suffer serious punishment based on the law.
The third step is the submission of the collected package of documents. They should be prepared in two copies: one to submit to the appropriate authority, the second to keep. There are three submission methods:
- come personally to the state structure;
- send the whole package by registered mail;
- ask for help from specialists (for this you will need to issue a power of attorney for).
The final stage is obtaining a license. From the date of submission of documents, your situation will be considered for a month and a half, after which a decision will be made.
- In a positive case, a notification will be sent to the mail and within three days it will be possible to pick up the license.
- If the decision is negative, the reason will be given. There are times when it seems unfair, and the refusal is unreasonable, then you can try to appeal it.
Period when the license is valid
Until 2011, such a license had a validity period of 5 years, after which it was necessary to re-register the documents again. However, not so long ago this rule was excluded, and now the permit does not have an expiration date: it is indefinite. However, sometimes you have to collect documents again for registration. This is done if any of the following list has changed:
- legal address of the clinic;
- medical services provided;
- passport data of an individual entrepreneur.
Violations and fines
Sometimes, if violations are found, the license may be suspended for six months - during this time you must resolve all problems. Then again send the documents to the public service, and after a while the answer comes.
In addition, if suddenly a citizen decides to engage in dental activities without obtaining a license, this is considered a serious administrative violation and brings serious consequences. For example, fines and suspension of work for a certain period.
- For legal entities, such a fine will range from 500 to 1,000 rubles.
- An individual entrepreneur will pay from 30,000 to 40,000 rubles, or suspend the clinic for up to three months.
- Organizations will suffer damage from 170,000 to 250,000 rubles, or close the clinic for about 120 days.
This shows that it is best to complete all the documents on time than to lose rather large sums of money in the future and again deal with paperwork.
Obtaining a dental office license
If you want to open a business, a dental office is a great investment! However, remember that it is important to get a license to work. To do this, you will need to make a lot of efforts: get permission from Rospotrebnadzor, conclude agreements with various services that will service the office and equipment, and also hire professional employees - their work experience should not be less than five years.
If you do everything right, then getting permission is not so difficult, and you can safely earn money doing what you love!
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Hello Vera!
The regulations that today determine the requirements for licensing dental services are:
- 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); Federal Law of August 08, 2001 No. “On licensing certain types of activities” (as amended on December 30, 2008); Decree of the Government of the Russian Federation of January 22, 2007 No. “On Approval of the Regulations on Licensing Medical Activities”; 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 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), ambulance and emergency specialized (sanitary and aviation), high-tech, sanatorium-resort medical care "(as amended on 23.01.2009 .); Order of the Ministry of Health and Social Development of December 1, 2005 No. No. 753 "On equipping outpatient and inpatient polyclinic institutions of municipalities with diagnostic equipment." SanPin 2.1.3.1375-03 "Hygienic requirements for the placement, arrangement, equipment and operation of hospitals, maternity hospitals and other medical hospitals"; Sanitary rules for the device, equipment, operation of outpatient clinics of a dental profile, labor protection and personal hygiene of personnel (approved by the Chief State Sanitary Doctor of the USSR dated December 28, 1983 No. 2956a-83); and offices of private practitioners of a dental profile (approved by the Chief State Sanitary Doctor for Moscow on October 10, 1998 No. 12 / 22-758) You will find a more detailed answer to all your questions here .. http://www.fabrikabiz.ru/stomatology /14/1.php
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Good afternoon! To obtain a license to provide dental services using general anesthesia, you need to contact the Ministry of Health in your area. In addition, it is necessary to have special equipment designed to monitor the patient's condition and, before applying to the ministry, introduce the position of an anesthesiologist (as far as I know, this is a mandatory condition). Also, when obtaining a license, the technical equipment of the premises of the dental clinic and the professional level of the doctors who work in it are taken into account.
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According to
REGULATIONS ON LICENSING OF MEDICAL ACTIVITIES
(as amended by Decrees of the Government of the Russian Federation of 04.09.2012 N 882, of 17.01.2013 N 9, of 15.04.2013 N 342)
4. Licensing requirements for a license applicant for
implementation of medical activities (hereinafter referred to as the license), are:
a) the presence of buildings, structures, structures and (or) premises belonging to
license applicant on the basis of ownership or other legal
the basis necessary for the performance of the declared works (services) and
meeting the established requirements;
b) the presence of the license applicant on the right of ownership or
on another legal basis of medical devices (equipment, devices,
devices, tools) necessary for the performance of the declared work
(services) and duly registered;
c) availability:
at the head of a medical organization, deputy heads
medical organization responsible for the implementation of medical
activities, the head of a structural unit of another organization,
responsible for the implementation of medical activities, - the highest
medical education, postgraduate and (or) additional
vocational education provided for by qualification
requirements for specialists with higher and postgraduate medical
education in the field of health care, a certificate of a specialist, as well as
additional professional education and specialist certificate
in the specialty "health organization and public health";
the head of an organization that is part of the federal
state sanitary and epidemiological supervision, or its
deputy responsible for the implementation of medical activities - higher medical education, postgraduate and (or)
additional professional education provided for
qualification requirements for specialists with higher and postgraduate
medical education in the field of healthcare, certificate
specialist, as well as additional professional education and
certificate of a specialist in the specialty "social hygiene and
organization of the State Sanitary and Epidemiological Service”;
at the head of the structural unit of the medical organization,
carrying out medical activities - higher professional
education, postgraduate (for specialists with medical
education) and (or) additional professional education,
specialist certificate (for specialists with medical education);
from an individual entrepreneur - higher medical education,
postgraduate and (or) additional professional education,
stipulated by the qualification requirements for specialists with higher and
postgraduate medical education in the health sector, and
certificate of a specialist, and if you intend to provide first aid
- secondary medical education and a certificate of a specialist in
relevant specialty;
d) the persons specified in subparagraph "c" of this paragraph have work experience in the specialty:
at least 5 years - with higher medical education;
at least 3 years - with a secondary medical education;
e) the presence of labor contracts concluded with the license applicant
employees with secondary, higher, postgraduate and (or)
additional medical or other necessary to perform
declared works (services) vocational education and certificate
specialist (for specialists with medical education);
f) the presence of labor contracts concluded with the license applicant
workers involved in the maintenance of medical devices
(equipment, apparatus, devices, tools) and having the necessary
vocational education and (or) qualifications, or the existence of a contract
with an organization licensed to carry out the relevant
activities;
g) compliance with the structure and staffing of the license applicant -
legal entity included in the state or municipal system
health care, general requirements established for the relevant
medical organizations;
h) Compliance of the license applicant - legal entity:
intentionally perform the declared work (services) for the circulation of donor
blood and (or) its components for medical purposes, - the requirements,
established by Article 13 of the Law of the Russian Federation "On blood donation and
its components";
intentionally perform the declared work (services) for transplantation
(transplantation) of organs and (or) tissues, - the requirements established by Article
4 of the Law of the Russian Federation "On transplantation of organs and (or) tissues
person";
intending to carry out a medical and social examination, - established
Article 60 of the Federal Law "On the Fundamentals of Protecting the Health of Citizens in
Russian Federation” and Article 8 of the Federal Law “On Social
Protection of Persons with Disabilities in the Russian Federation” requirements relating to
organizational and legal form of a legal entity;
i) availability of internal quality control and safety of medical activities.
To obtain a license, the license applicant sends or
submits to the licensing authority in accordance with paragraph 1 of Article 13
Federal Law "On Licensing Certain Types of Activities"
an application for a license, to which are attached:
a) copies of the constituent documents of the legal entity, certified by a notary;
b) copies of documents confirming that the applicant has a license
buildings, structures, structures and (or) premises necessary for
performance of the declared works (services), the rights to which are not
registered in the Unified State Register of Rights to Real Estate
property and transactions with it (if such rights are registered in
the specified register, - information about these buildings, structures, structures and
(or) premises);
c) copies of documents confirming that the applicant has a license
belonging to him on the right of ownership or on any other legal basis
medical products (equipment, devices, devices, tools),
necessary for the performance of the declared works (services);
d) information on the availability of a duly issued
sanitary and epidemiological conclusion on compliance with sanitary
rules of buildings, structures, structures and (or) premises necessary for
e) information on the state registration of medical devices
(equipment, apparatus, devices, instruments) necessary for
fulfillment by the license applicant of the declared works (services);
f) copies of documents confirming that the persons specified in subparagraph
"c" of paragraph 4 of these Regulations, the corresponding professional
education, certificates, work experience in the specialty;
g) copies of documents confirming that the persons specified in subparagraph
"e" of paragraph 4 of these Regulations, the corresponding professional
education and certificate of a specialist (for specialists with medical
education);
h) copies of documents confirming that the persons specified in subparagraph
"e" of paragraph 4 of these Regulations, the corresponding professional
education and (or) qualifications, or a copy of the contract with the organization,
licensed to carry out relevant activities;
i) a copy of the document confirming the payment of the state fee for the grant of a license;
j) a description of the attached documents.
According to SanPiN 2.1.3.2630-10
Requirements for organizations engaged in medical activities
3. Requirements for buildings, structures and premises
3.1 Architectural planning and design solutions for buildings and
premises for medical activities should provide
optimal conditions for the implementation of medical and diagnostic
process, compliance with the sanitary and anti-epidemic regime and labor
medical personnel. The height of the premises is allowed at least 2.6
m.3.2 In medical organizations, conditions must be created for
convenient access and comfortable stay for people with limited mobility
population.3.3 The structure, layout and equipment of the premises should
ensure the flow of technological processes and exclude
the possibility of crossing flows with varying degrees
epidemiological danger.3.4 Each medical and diagnostic unit should
provide for the office of the head, the premises of the senior medical
nurses, staff quarters.3.14 In medical organizations where parenteral
manipulations with the use of reusable medical instruments,
central sterilization departments should be provided
(CSO), the area and composition of which is determined by the profile and thickness
institutions.
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The main requirements for the premises are set out in the document
SANITARY AND EPIDEMIOLOGICAL REQUIREMENTS FOR ORGANIZATIONS CARRYING OUT MEDICAL ACTIVITIES
Sanitary and epidemiological rules and regulations SanPiN 2.1.3.2630 - 10
Rospotrebnadzor should issue a sanitary and epidemiological conclusion to your organization stating that your premises correspond to the type of activity you are declaring and this conclusion is attached to the set of documents for obtaining a medical license.
the requirements for specialists and the composition of documents submitted for obtaining a license are set out in Decree of the Government of the Russian Federation of April 16, 2012 N 291 - they approved the Regulation on licensing medical activities.
If, in the process of anesthetizing patients of the clinic, you use drugs listed as NA and PV, in addition to a medical license, you also need to obtain another license to carry out activities for the circulation of narcotic drugs and psychotropic substances and their precursors, the cultivation of narcotic plants, which requires a special room for the storage of NA and PV and security alarm system of this room.
On the approval of the procedure for providing medical care to the adult population in case of dental diseases. The requirements for the availability of certain rooms and the requirements for specialists in the dental profile are indicated.
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Plyasunov Konstantin
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Dear Vera!
Dental services are included in the list of medical services that are subject to licensing (Article 17 of the Federal Law “On Licensing Certain Types of Activities”, Regulations on the Licensing of Medical Activities).
Sanitary and epidemiological requirements for organizations engaged in medical activities - SanPiN 2.1.3.2630-10, approved by the Decree of the Chief State Sanitary Doctor of the Russian Federation of 05/08/2010 N 58.
Ch. V SanPiN is completely devoted to sanitary and hygienic requirements for dental medical organizations.
Clause 2.10. In dental offices, the area for the main dental unit should be at least 14 m2, for an additional unit - 10 m2 (for a dental chair without a drill - 7 m2), the height of the cabinets should be at least 2.6 m.
clause 2.11. Surgical interventions, for which medical activities in anesthesiology and resuscitation are carried out, are carried out in the conditions of the operating unit. At the same time, a room for temporary stay of the patient after the operation is equipped. In the operating room, if necessary, the supply of medical gases is provided.
clause 2.12. The work of the office of surgical dentistry is organized taking into account the separation of the flows of "clean" (planned) and "purulent" interventions. Planned interventions are carried out on specially allocated days with a preliminary general cleaning.
clause 2.13. The set of premises is determined by the capacity of the dental medical organization and activities. The minimum area of premises and their minimum set are presented in Annex 2.
3. Requirements for interior decoration
3.1 For interior decoration, materials are used in accordance with the functional purpose of the premises.
3.2 The walls of dental offices, corners and junctions of walls, ceiling and floor must be smooth, without cracks.
3.3 To finish the walls in the offices, finishing materials are used that are approved for use in rooms with a wet, aseptic regime, resistant to disinfectants. The walls of the operating room, surgical dentistry and sterilization rooms are finished to the full height with glazed tiles or other materials permitted for these purposes.
3.4 The walls of the main premises of the dental laboratory are painted with paints or lined with panels that have a smooth surface; seams are hermetically sealed.
3.5 Ceilings of dental rooms, operating rooms, preoperative rooms, sterilization rooms and dental laboratory rooms are painted with water-based or other paints. It is possible to use suspended ceilings if this does not affect the normative height of the room. Suspended ceilings must be made of slabs (panels) with a smooth, non-perforated surface that is resistant to detergents and disinfectants.
3.6 Floors in dental offices should be smooth with materials approved for this purpose.
3.7 The color of the surfaces of walls and floors in the premises of dental offices and dental laboratories should be of neutral light tones that do not interfere with the correct color differentiation of the shades of color of the mucous membranes, skin, blood, teeth (natural and artificial), filling and prosthetic materials.
3.8 When decorating dental offices that use mercury amalgam:
walls and ceilings should be smooth, without cracks and decorations; plastered (brick) or worn (panel) with the addition of 5% sulfur powder to bind mercury vapor into a strong compound (mercury sulphide) and painted with paints approved for dental offices;
floors should be laid with roll material, all seams are welded, the plinth should fit snugly against the walls and floor;
tables for working with amalgam should be covered with mercury-resistant material and have borders at the edges; there should be no open drawers under the working surface of the tables; only amalgam produced in hermetically sealed capsules is allowed to be used.
4. Equipment requirements
4.1 In rooms with one-sided natural lighting, dental chairs are installed in one row along a light-bearing wall.
4.2 If there are several dental chairs in the office, they are separated by non-transparent partitions with a height of at least 1.5 m.
4.3 The absence of a sterilization room in a dental medical organization is allowed if there are no more than 3 chairs. In this case, the installation of sterilization equipment is possible directly in the cabinets.
4.4 Dental rooms are equipped with separate or two-section sinks for washing hands and processing instruments. If there is a sterilization room and the organization of centralized pre-sterilization processing of instruments in it, one sink is allowed in the cabinets. In the operating unit, the sinks are installed in the preoperative room. Elbow or sensor mixers are installed in surgical rooms, sterilization rooms, preoperative rooms.
4.5 Premises of dental laboratories and dental offices in which work with gypsum is carried out must have equipment for the precipitation of gypsum from wastewater before descending into the sewer (gypsum traps or others).
4.6 Cabinets are equipped with bactericidal irradiators or other air disinfection devices permitted for this purpose in the prescribed manner. When using open-type irradiators, the switches must be placed outside the working premises.
According to the text
When licensing dental activities in the direction of implantology, you need to apply for a valid license.
In this case, an increase in own or rented area will be required:
Thus, the sanitary rules for the introduction of implantology provide for the following additional areas:
- 24 sq.m. for a small operating room; 8 sq.m for a preoperative room; 2 sq.m - a gateway; 10 sq.m - a ward for a temporary stay of a patient after an operation.
- - surgical dentistry;
- anesthesiology (resuscitation). In addition, the staff of the organization must be a dentist-surgeon with a certificate of advanced training in implantology.
Hello. Your activity is governed by the following regulatory framework
In accordance with subparagraph 46 of Article 12 of the Federal Law of May 4, 2011 N 99-FZ "On Licensing Certain Types of Activities", medical activities are subject to licensing.
Industry classifier "Simple medical services" OK PMU 91500.09.0001-2001 (entered into force on May 1, 2001 by Order of the Ministry of Health of April 10, 2001 No. 113)
Another Order of the Ministry of Health and Social Development of the Russian Federation of December 27, 2011 No. 1664n (registered in the Ministry of Justice of the Russian Federation on January 24, 2012 No. 23010).
"Regulations on the licensing of medical activities ..." (approved by Decree of the Government of the Russian Federation of April 16, 2012 N 291).
According to the law, medical activity on the territory of the Russian
Federation, cannot be performed without a license from the Ministry of Health, this
everyone knows.
First, if the entity receiving the license wants to
open a medical clinic or office, she should pay attention to
premises that must legally belong to the organization,
for example, is owned or be rented. Moreover, the chosen
the area must comply with all sanitary and epidemiological requirements,
applied to medical organizations. in number
such requirements include the availability of natural light, a bathroom, a room for
personnel, etc.
And here the main problem begins. If matched
personnel for some reason does not meet the requirements, then it is not possible to replace it
such a big problem. But to replace the owned, and even worse,
renovated and equipped premises, which suddenly turned out to be
meeting the requirements is, as a rule, a game that is not worth the candle.
Expert advice is this: you need to pay attention to
list of works (services) that the license applicant plans to carry out
according to the order of the Ministry of Health and Social Development of Russia dated May 10, 2007 N 323, taking into account
all changes in legislation that have come into force. Also, the provisions on
organization of medical practice, where you can see all the requirements for
room - how many squares of area will be needed for a particular type
activities. For example, two therapists can be in the same office,
when as doctors with different profiles, different rooms may be required.
A gynecologist needs several rooms to work (an office for receiving and
viewing room).
Thus, from the above, it follows that
it is enough to miscalculate a couple of square meters, missing in the calculation
any type of activity, and obtaining a license, if it does not become impossible,
it becomes much more difficult. Here is the cornerstone for you, literal and figurative
sense.
Secondly, it is necessary to carefully consider all
the requirements set by the Ministry of Health for equipping specific
activities. It is necessary to carefully monitor the safety of all technical
passports, certificates of conformity, registration certificates and verification data
equipment. The bottom line is that the requirements of the Ministry of Health change very often, and if
now they may not find fault with technical documentation, then in six months it will
may be of interest to the licensing authority. However, do not close
eyes on any of the clauses of the provision on the type of activity, t.to. even because
minimal inconsistencies can cause problems. Recall that for each
type of activity, there is a list of equipment, which includes
medical equipment, and furniture. Roughly speaking, one cannot assume that the "nightstand
- not a scalpel, ”and therefore you can do without. Due to the lack of, for example,
bedside tables (which is indicated in the complete list of equipment), there may be
complaints from the licensing authority.
Thirdly, we turn to the issue of recruitment in
an organization that receives a medical license. Here you need to start with
head of an organization wishing to obtain a medical license, according to general
the rule must have a higher medical education, a valid certificate
a specialist with a valid advanced training, as well as an additional
vocational education and a certificate in the specialty "organization
health and public health". But what if the leader is not
has any of the above? It's simple: you need to assign
deputy head of the medical organization responsible for
implementation of medical activities, which, in turn, must
meet all requirements of the regulation.
However, if the license is obtained for an individual entrepreneur,
then the last certificate in the specialty "organization of health care and
public health is not needed. At the same time, the individual entrepreneur
obtaining a license must personally meet all the requirements for those types of
the activities it claims. Sole Proprietors are not allowed to hire employees.
Likewise, an organization applying for a license,
it is necessary to monitor the expiration dates of the certificates of all employees, and
to carry out their extension in advance, otherwise, during the preparation of documentation
to obtain a license, the certificates of some specialists may be
overdue. And until they complete advanced training courses, the organization
will not be able to obtain a license. The best advice in this case is to improve your skills
in advance rather than postponing.
Fourth, there is an acute issue of quality control, which
all employees of an organization receiving a medical license must
pass. And here we come to another cornerstone: how
undergo a quality control procedure if the organization itself undergoing
licensing, does not have the right to this type of activity? According to
specialist, this issue can be solved using two options, each of
which are associated with certain difficulties.
The first option is suitable for those organizations that are ready to
obtain a license to carry out quality control. In this case, it is allowed
the possibility in the application for a medical license to also indicate this
Kind of activity. Having received such a license, the institution will independently
control your activities. But, obtaining a license for this type
activities is almost unbearable for small organizations. Because current
legislation establishes the following requirements for the implementation of this
type of activity: to have at least five specialists of different profiles in the staff,
which will be included in the commission for quality control, and the presence of one of
these employees of additional training on the implementation
quality control, which will be the chairman of this commission.
The second option is to conclude an agreement with an organization that
has a license to carry out quality control of medical activities, and
agrees to do so for the applicant organization. But, as practice shows, this
option is not as easy as it seems. In modern realities it is very difficult
it is possible to find an institution that will agree to take responsibility for
medical activities of specialists of a third-party organization, tk. putting your
signature, members of the quality control committee automatically become
responsible for all the mistakes of "controlled" doctors. Therefore, in order to get
their signatures, you need to have a fairly trusting relationship with
quality control organization.
The cost of a dental license (including an X-ray room) is from 45,000 rubles.
A license to practice medicine is required if you are running 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 for dental services as soon as possible.
Dentistry Licensing the process is very time-consuming and if you deal with this issue yourself, the process of obtaining a license can take up to one year.
Our experts will take care of visiting all the necessary authorities and the hassle of forming the entire package of documents. We are the only ones who give 100% license acquisition after 45 days.
Today, a modern dental clinic cannot do without the use of an X-ray machine. If you are planning to use an X-ray machine, you must include an X-ray license as part of your dental license. This procedure is very specific and only a few companies undertake this procedure. As a result, the licensing process drags on for years. Therefore, it is important to entrust the licensing of dental activities to professionals in this field.
What documents must be submitted to obtain a dental license:
- Constituent documents: TIN, PSRN, charter, organization card, certificate of ownership of the premises, lease agreement with an act of acceptance of the transfer of the premises, certificates of state registration of the organization, extract from the Unified State Register of Legal Entities.
- Positive conclusion of Rospotrebnadzor (conclusion of the SEZ) on the premises for the declared activities.
- Documents on the education of medical personnel (diploma of medical education, internship / residency, certificates, certificates of advanced training, diplomas of professional retraining, inserts for diplomas, passport).
- Documents for equipment and furniture (waybills, registration certificates for furniture and equipment). All equipment and furniture must have Registration Certificates.
- Contract for the maintenance of medical equipment. Medical equipment must be delivered for maintenance with an organization that has a license for the maintenance of medical equipment.
- The paid state duty is 7,500 rubles for issuing a license, 3,500 rubles for reissuing a license. The state duty must be paid from the bank account of the organization.
How to get a dental license?
To obtain a license for dental activities, it is enough:
- Arrange a meeting at our Center or at your facility
- Provide us with a copy of the floor plan and constituent documents
- Conclude an agreement with us
- We will do the rest of the work for you!
Dental license is issued indefinitely!
The Unified Medical Licensing Center guarantees obtaining an x-ray license the fastest in the city. Our specialists will be able to complete the entire cycle of work to prepare the premises for the X-ray room: they will develop a project, make repairs, and receive laboratory tests. They will also receive two final studies of Rospotrebnadzor: for a source of ionizing radiation, as well as a medical certificate for radiology in dentistry.