Licensing for SP dental technician. Medical activities Requirements necessary for the implementation of the activities of a dental laboratory

In accordance with paragraph 5 of Appendix No. 1 to the Procedure for the provision of medical care to the adult population with dental diseases, approved. By order of the Ministry of Health and Social Development of the Russian Federation of December 7, 2011 No. 1496n, a dental laboratory may be a structural unit of a dental clinic or other medical organization providing primary health care on an outpatient basis (see Appendix No. 2 to the above Order). However, in practice, a dental laboratory can exist and more often exists as a separate medical organization.

As follows from clause 11 of Appendix No. 2, the function of a dental laboratory is the manufacture of dentures, maxillofacial prostheses and orthodontic appliances.

Thus, based on the above provisions, we can conclude that a dental laboratory is a type of dental medical organization that is subject to SanPiN 2.1.3.2630-10 "Sanitary and epidemiological requirements for organizations engaged in medical activities", approved. Decree of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare dated May 18, 2010 No. 58 (hereinafter - SanPiN 2.1.3.2630-10) and, in particular, the action of Chapter 5 "Sanitary and Hygienic Requirements for Dental Medical Organizations". Below we consider some special requirements for the placement of a dental laboratory.

When choosing premises for a dental laboratory, the type of work to be performed should be taken into account. So, in paragraph 5.16. ch. 5 SanPiN 2.1.3.2630-10 states that dental laboratories for 1 or 2 workplaces in which work is performed that is not accompanied by the release of harmful substances (for example: applying and firing ceramic mass, turning and other work) can be placed in residential and public buildings, from which it follows that if work is performed in a dental laboratory, accompanied by the release of harmful substances, then such a laboratory cannot be located in a residential and public building. Works accompanied by the release of harmful substances include work with precursors of narcotic drugs and psychotropic substances (for example, methyl acrylate and methyl methacrylate), which are often used in dental technology.

As a general rule, the set of premises of a dental laboratory is determined by the capacity of the medical organization under which the laboratory was created, or by the types of work that is planned to be performed in it if the dental laboratory is an independent medical organization.

Conventionally, all the premises of the dental laboratory can be divided into 2 groups: the main premises, which include the offices of dental technicians, and specialized ones, which include polymerization, gypsum, polishing, soldering and casting.

Table 1 below shows the minimum dimensions of the premises of the dental laboratory and gives some notes to which you should pay special attention.

Table 1.
The minimum dimensions of the areas of the dental laboratory

The name of a room	Minimum area, sq.m.	Note
Dental laboratory: dental technicians' room	7	4 sq.m. per technician, but no more than 10 technicians in one room
Specialized rooms: polymerization, gypsum, polishing, soldering	7	If there is a dental laboratory for 1-2 staff units of dental technicians, it can be placed in two rooms - in one of the rooms, the processes of plastering, polishing, polymerization, soldering are combined, in the other - the workplace of a dental technician. At the same time, the area of ​​both offices must be at least 14 sq.m.
Foundry	4	Depending on the technology and dimensions of the equipment, the area may be changed

In section 3 ch. 5 SanPiN 2.1.3.2630-10 establishes the following rules that must be observed when decorating the premises of a dental laboratory:

• 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.
• The ceilings of dental laboratories are painted with water-based or other paints. It is possible to use false ceilings if this does not affect the normative height of the room. Suspended ceilings in this case should be made of plates (panels) with a smooth non-perforated surface that is resistant to detergents and disinfectants.
• Floors must be smooth and made of materials approved for this purpose.
• The color of the surfaces of walls and floors in the premises of 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.
• If mercury amalgam is used in the premises of the dental laboratory, then:
  • walls and ceilings of these rooms 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.

The dental laboratory houses equipment, the list of which is given in the Order of the Ministry of Health and Social Development of the Russian Federation of December 7, 2011 No. 1496n in the section “Standards for equipping the dental (dental) laboratory of a dental clinic” and in the Order of the Ministry of Health of Russia of November 13, 2012 No. 910n (as amended on 03.08. 2015) in the section "Orthodontic dental laboratory equipment standard".

SanPiN 2.1.3.2630-10 does not contain any special requirements for the arrangement of equipment in the premises, with the exception of the following:

• In the premises of dental laboratories where work with gypsum is carried out, equipment must be installed for the precipitation of gypsum from wastewater before descending into the sewer (gypsum traps, etc.).
• The location of the tables of dental technicians in the main premises of the dental laboratory should provide left-sided natural lighting for workplaces.

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First of all, it should be noted that according to the rules of Sec. 5 SanPiN 2.1.3.2630-10 for industrial premises of dental laboratories, autonomous ventilation systems should be provided.

Depending on the technological part of the project, dental laboratories also provide for local suction from the workplaces of dental technicians, grinding motors, in the foundry above the furnace, in the soldering room, above the heating devices and work tables in the polymerization room. Work with harmful chemicals (cytostatics, psychotropic drugs, chemical reagents) is similarly allowed, provided that local exhaust devices are used. At the same time, the technological equipment of dental laboratories, which includes sections for cleaning the air removed from this equipment, as well as closed-loop equipment, does not require additional local suction.

In the premises of dental laboratories, local exhausts and general exhaust ventilation can be combined into one exhaust system within the laboratory premises or in the ventilation chamber. It is allowed to arrange a general general supply ventilation for the premises of laboratories and other premises of a dental medical organization, while the supply of supply air to the premises of the laboratory should be provided through an independent air duct passing from the ventilation chamber, with a check valve installed on it within the ventilation chamber. The air emitted into the atmosphere should be cleaned in accordance with the technological characteristics of the equipment and materials.

In dental laboratories for 1 or 2 workplaces, in which work is performed that is not accompanied by the release of harmful substances (for example: applying and firing ceramic mass, turning and other work), unorganized air exchange in the room is allowed by ventilation through transoms or using natural exhaust ventilation with 2-fold air exchange through an autonomous ventilation duct with access to the roof or external wall without light openings.

According to the requirements of SanPiN 2.1.3.2630-10, all premises of dental laboratories (permanent workplaces) must have natural lighting, the coefficient of which must comply with the hygienic requirements established by the current sanitary standards.

When designing a dental laboratory, it should be borne in mind that, if possible, it is recommended to orient the main premises and foundries of a dental laboratory to northern directions to prevent overheating of the premises in the summer. In existing dental medical organizations with window orientation that does not correspond to the above direction, you can resort to the use of sun protection devices (visors, sun protection films, blinds).

As a general rule, all premises of dental medical organizations should have general artificial lighting. For fluorescent lighting in the main rooms of the dental laboratory, lamps with an emission spectrum that does not distort color reproduction are recommended. At the same time, general lighting fixtures should be placed in such a way that they do not fall into the field of view of the working doctor.

The polishing rooms of the dental laboratory, in addition to general lighting, should also have local lighting. Local lighting can be in the form of:

• dental lamps in dental units;
• special (preferably shadowless) reflectors for each surgeon's workplace;
• shadowless reflectors in operating rooms;
• lamps at each workplace of the dental technician in the main and polishing rooms.

The level of illumination from local sources should not exceed the level of general illumination by more than 10 times.

All lamps, both local and general lighting, must have appropriate protective fittings, providing for their wet cleaning and protecting the organs of vision of personnel from the blinding effect of lamps.

Nota bene! The Faculty of Medical Law reminds that the arrangement of tables of dental technicians in the main premises of the dental laboratory should provide left-sided natural lighting for workplaces.

And finally, the qualification requirements for the position of a dental technician are approved by the Order of the Ministry of Health of Russia dated February 10, 2016 No. 83n, namely: secondary medical education in the specialty "Orthopedic Dentistry" and a certificate of a specialist in the specialty "Orthopedic Dentistry".

Practical value

The criteria for placing a dental laboratory given in this article are relevant primarily for obtaining a sanitary and epidemiological conclusion (SEZ) in Rospotrebnadzor. Read more about this procedure in the "" section. At the same time, obtaining a free economic zone is not the only condition for the implementation of medical activities. The second important step towards opening a dental laboratory is obtaining a license. Information on the issue of licensing medical activities is presented in the section "".

DO YOU NEED A LICENSE TO MANUFACTURE DENTURES?

The answer to this question is not at all obvious, as it might seem at first glance.

Referring to the legislation "On Licensing Certain Types of Activities" Federal Law of 04.05.2011 N 99-FZ, we find out that the licensing of medical activities is regulated by the named law (part 5. Article 1 99-FZ), and since the activities of dental technicians is medical, then the organizations in which they work are subject to licensing.
But there is another opinion that "A license to manufacture dentures is not needed."
Let us analyze the existing legislation regarding the manufacture of dentures in the field of medicine, production and work of dental technicians.

The current All-Russian classifier of types of economic activity (OKVED-2) (approved Order of Rosstandart dated January 31, 2014 N 14-st) (as amended on February 20, 2019) group "Dental practice" (86.23) includes:
- activities in the field of dentistry, general or specialized, for example in the field of dentistry, endodontic and pediatric dentistry, oral pathology;
- activities in the field of orthodontics

This grouping does not include: . For this, a separate OKVED code is provided: 32.50

Thus, OKVED 32.50 considers the manufacture dental and orthodontic prostheses not as medicine or dental services, but as "Manufacture of medical instruments and equipment".
OKVED 32.50: Manufacture of medical instruments and equipment.
This grouping includes:
- manufacture of installations for laboratories, surgical and medical instruments, surgical instruments and spare parts, dental equipment and consumables, orthodontic products, dental and orthodontic prostheses

According to the All-Russian classifier of products OK 005-93, prosthetic and orthopedic products are included in the group of medical products. Therefore, the manufactured prosthetic and orthopedic products, their parts belong to medical products - code 93 0000.

In addition, the Law (99-FZ) establishes a requirement to obtain a license for the production of medical equipment - code 94 0000, to which these medical devices do not apply. A dental technician does not manufacture medical equipment. It manufactures dentures - medical products.

At the same time, there is Order of the Ministry of Health of Russia dated 06.06.2012 N 4n “On approval of the nomenclature classification of medical devices” which distinguishes: group 15 “Dental medical devices” and subgroups: 15.16 “Dental prostheses and related products” and 15.17 “Dental and related prostheses products".

Thus, the legislator knows about the existence of such medical products as: "Dental medical products" and "Dental prostheses".

In this case, they seem to be subject to state registration of medical devices.
But the Procedure for State Registration, approved by Decree of the Government of the Russian Federation dated December 27, 2012 No. 1416 “On Approval of the Rules for State Registration of Medical Devices” indicates that “Medical devices, custom-made for patients, which are subject to special requirements for the appointment of medical professionals and which are intended solely for the personal use of a particular patient, are not subject to state registration. Thus, the legislator does not require state registration of activities for the manufacture of dentures.
The foregoing suggests that a license for the manufacture of dentures is not required for a dental technician. It's not quite that clear.

There are options when a license is needed and when it is not needed.
Let's consider both. And both are correct.

Option 1: IF the dentures are made by dental technicians.
In the Nomenclature of specialties for specialists with secondary medical and pharmaceutical education in the healthcare sector of the Russian Federation "Order of the Ministry of Health and Social Development of the Russian Federation dated April 16, 2008 N 176n", "Orthopedic Dentistry" is indicated.
"OK 010-2014 (ISCO-08). The All-Russian Classifier of Occupations" distinguishes occupation No. 3214 "Dental technicians and prosthetist technicians". Dental technicians and prosthetic technicians can make dentures, crowns and bridges. Their responsibilities include: including: - manufacturing of complete and partial dentures, mouth guards, crowns, metal clips, inlays, bridges and other devices;

The duties of the Dental Technician include: Manufacture of artificial crowns, including metal ceramics, simple structures of pin teeth, bridge structures, removable laminar and clasp dentures, orthodontic and maxillofacial structures. (Order of the Ministry of Health and Social Development of the Russian Federation dated July 23, 2010 N 541n “On Approval of the Unified Qualification Handbook for the Positions of Managers, Specialists and Employees, Section “Qualification Characteristics of Positions of Workers in the Healthcare Sphere”). In order to take the position of a Dental Technician, you need to have a secondary vocational education in the specialty "Orthopedic Dentistry" (Order of the Ministry of Health of Russia dated February 10, 2016 N 83n "On Approval of Qualification Requirements for Medical and Pharmaceutical Workers with Secondary Medical and Pharmaceutical Education").

Until 30.04.2012, Decree of the Government of the Russian Federation dated 01.22.2007 N 30 “On Approval of the Regulations on Licensing Medical Activities” was in force, which detailed that the list includes services performed in the implementation of pre-medical, outpatient, inpatient, ambulance and emergency specialized, high-tech , spa medical care.
In the current Decree of the Government of the Russian Federation of April 16, 2012 N 291 “On licensing medical activities”, there is no detail regarding pre-hospital medical care.
This is due to the fact that Art. 33 of the Federal Law “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”, which entered into force on January 1, 2012, considers primary pre-hospital health care as part of primary health care, which is accordingly subject to licensing. In accordance with Decree of the Government of the Russian Federation N 291, orthopedic dentistry is subject to licensing, including when providing pre-hospital medical care.
Organizations that manufacture dentures by dental technicians need to obtain a license. Dental technicians with a secondary vocational education and a valid certificate in the specialty "Orthopedic Dentistry" can be accepted for a position in such an organization. The organization is considered medical.

Option 2: IF the manufacture of prostheses is NOT carried out by a dental technician, but by a specialist in the field of computer technology and production.

Imagine a workshop for the production of artificial teeth for removable prosthetics. Or a factory for the production of orthodontic trainers. Or a company that makes mouth guards (aligners) to correct an overbite.
Or a production machine shop with dozens of milling machines located in it, which sharpen titanium abutments, clasp, titanium bases day and night ...

In another workshop, models, spoons, mouthguards, temporary crowns are printed on 3D printers...

In the third room sits the staff - exclusively computer modeling specialists who have nothing to do with medicine. They receive STL files for modeling from doctors and clinics. And work with them programmatically.
They are really cool at working with 3D graphics. And they don't care what to model and send for printing or milling: a set of toy soldiers or dentures modeled on a CAD program.
And now they calmly model their prostheses, saw, print.
They work officially under contracts, receive payment by bank transfer, pay salaries, funds and taxes.
Tell me, does this description look like a dental laboratory? Not especially, really. It really looks like a factory.

Do they have the right to manufacture medical devices in a factory this way? Certainly! And why? For the reasons that we discussed above - Order of the Ministry of Health of Russia dated 06.06.2012 N 4n "On approval of the nomenclature classification of medical devices" which distinguishes: group 15 "Dental medical devices" and subgroups: 15.16 "Dental prostheses and related products" and 15.17 "Prostheses dental and related products” distinguishes them into an independent product of production.

IMPORTANT! Please note - this is not a nomenclature of medical SERVICES by order of the Ministry of Health of the Russian Federation 804n, but a nomenclature of medical PRODUCTS by order of the Ministry of Health of the Russian Federation No. 4n!

And the manufacture of such products is not included in the list of activities for which a license is required. Does not require medical education from the manufacturer as mandatory.
And therefore, those who, in the second option, make them, are not medical workers and do not provide medical services, as is the case with the performance of the SAME work by a dental technician with a medical education. They are anything - a 3D designer, a CNC programmer, a printer maintenance worker...
And it is not at all necessary to be a huge factory for the manufacture of medical devices. And a simple small laboratory can be designed this way, the main thing is to know how to do it right.

Main conclusions:
1. A dental technician is a HEALTH WORKER. Therefore, the manufacture of medical products in the form of dentures by his hands is considered a medical activity, and the products are classified by order of the Ministry of Health of the Russian Federation as a "Medical service".
2. Code 32.50, 33.10.1 and other production codes are NOT SUITABLE for dental technicians. He has the right to work only as a health worker under the medical OKVED.
3. To make dental prostheses as a "Dental Technician" profession, it is indeed REQUIRED to obtain a medical license for ZTL. The activity of a dental laboratory in the Russian Federation is subject to licensing as a medical one. Definitely so.
4. The manufacture of dentures may not be medicine, but production. The key difference is the design of ALL business processes as production. And the use of the labor of employees who are not registered as health workers (a dental technician is a health worker, do not forget!).
5. If the manufacture of dentures is formalized as a production, then you need to be able to create and really defend in front of the inspectors a large package of documentation that distinguishes this production from medicine and a dental laboratory.
6. If, during the check, you cannot prove with documents that you are not engaged in medical activities (and the line is very thin and only very competent specialists in medicine and jurisprudence can really translate this into documents), then you will be charged with carrying out activities without a license with all ensuing legal consequences. About which dental technicians for some reason prefer not to know. But if you are convicted and accused - this is what will happen:

Administrative penalty:
Code of Administrative Offenses of the Russian Federation
Article 14.1. Carrying out entrepreneurial activities without state registration or without a special permit (license)

Punishment:
2. Carrying out entrepreneurial activities without a special permit (license), if such a permit (such license) is mandatory (mandatory),
entails the imposition of an administrative fine
- on the citizens in the amount of two thousand to two thousand five hundred rubles with or without confiscation of manufactured products, production tools and raw materials;
- for officials - from four thousand to five thousand rubles with or without confiscation of manufactured products, production tools and raw materials;
- for legal entities - from forty thousand to fifty thousand rubles with or without confiscation of manufactured products, production tools and raw materials.

It would seem - well, even if caught - well, we will pay a fine and that's it. But read this carefully: "... with confiscation of manufactured products, production tools and raw materials or without it."

Speaking in human terms, everything you work with is CONFISCATED - an oven for pressing ceramics, a casting, all brushes and masses, a dental motor, etc. Such a measure is understandable - to prevent a relapse, so that after paying the fine, he would not continue to violate.
Here's how much it will cost.

Do you think that's it? Wrong!

There is also a CRIMINAL punishment for this. And even its own special article:
Criminal Code of the Russian Federation, Article 235.1. Illicit production of medicines and medical devices(introduced by Federal Law No. 532-FZ of December 31, 2014)

1. Manufacture of medicines or medical devices without special permission (license), if such permission (such license) is obligatory (obligatory), -
punished imprisonment for a term of three to five years with a fine in the amount of five hundred thousand to two million rubles or in the amount of wages or other income of the convicted person for a period of six months to two years, or without it.
2. The same acts committed:
a) an organized group;
b) on a large scale, -
are punished imprisonment for a term of five to eight years with a fine of one million to three million rubles or in the amount of wages or other income of the convicted person for a period of one to three years, or without it.
Note. The large amount in this article is the cost of medicines or medical devices that exceeds one hundred thousand rubles.

So, have you read it?
Now realize:
1. Working without a license is not only an administrative, but also a CRIMINAL offense
2. Punishment simply for being caught - from 3 to 5 years in prison + a fine of up to 2,000,000 rubles.
3. If the investigation proves that in the laboratory you worked as a group (and this is two or more people) - a term of 5 to 8 years in prison and a fine of up to 3,000,000 rubles.
4. If you work all alone as an individual entrepreneur, but at the same time the investigation has proved that you receive income from such work in the form of a large amount ( The large amount in this article is the cost of medicines or medical devices in excess of 100,000 (One hundred thousand rubles. ) - receive from - term from 3 to 5 years in prison + a fine of up to 2,000,000 rubles.
Cool? All the steward earned - they went for 8 years, paid a fine of 3 million in a criminal case, and plus everything, they confiscated all dental equipment ... How do you like the prospect?

Well, dear technicians, do you still want YOURSELF without regard to knowledge of the laws and the help of professionals to continue working without a license, proudly poking everyone with the code 32.50 and considering this the main defense argument? Then they will come for you sooner or later, a matter of time.

There are no freebies and simple ways in our country. If you want to save on licenses and avoid inspections in medicine, then you need to pay professionals for the competent registration of their activities as production. Don't do this on your own. Or get a medical license, or do the production by the forces of those who understand this. Otherwise - see above ...

The article uses materials from the site http://medyurist.pro from the publication of Kirill Gennadyevich Redko in order to present a different, deeply substantiated opinion of the author of this article on the discussed issue of the need to license the production of medical dental products.

I want to create an IP. I ask you to clarify the need for licensing the OKVED code 33.10.1 - the manufacture of artificial teeth

Answer. Order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1183n approved the nomenclature of positions of medical and pharmaceutical workers, including the position of a dental technician.

In addition, the Unified Qualification Directory for the positions of managers, specialists and employees,

approved by order of the Ministry of Health and Social Development of Russia dated July 23, 2010 No. 541n, contains the duties of a dental technician: the manufacture of various types of artificial crowns, including metal-ceramic, simple designs of pin teeth, various designs of bridges, removable lamellar and clasp prostheses, orthodontic and maxillofacial structures. A dental technician prepares dental equipment and equips a dental laboratory for work, monitors their serviceability and correct operation. Provides first aid in emergencies. Must know: laws and other regulatory legal acts of the Russian Federation in the field of healthcare; basics of medical dental care; organization of activities in the dental laboratory; characteristics of the main materials used in denture technology; manufacturing technology of dental maxillofacial prostheses and orthodontic appliances; rules for the use of porcelain and cermets in denture technology; fundamentals of the functioning of budget-insurance medicine and voluntary medical insurance; basics of epidemiology; fundamentals of valeology and sanology; basics of disaster medicine; fundamentals of labor legislation; internal labor regulations; rules on labor protection and fire safety.

Requirements for the qualification of a dental technician: secondary vocational education in the specialty "Orthopedic Dentistry" and a certificate of a specialist in the specialty "Orthopedic Dentistry" without presenting requirements for work experience.

In addition, the procedures for providing medical care include a standard for equipping a dental technician’s office and a standard for equipping a dental (dental) laboratory of a dental clinic (order of the Ministry of Health of Russia dated November 13, 2012 No. 910n “On approval of the procedure for providing medical care to children with dental diseases” and an order of the Ministry of Health of Russia dated 07.12.2011 No. 1496n “On approval of the procedure for providing medical care to the adult population in case of dental diseases”).

According to Art. 37 of the Federal Law of November 21, 2011 No. 323-FZ “On the Basics of Protecting the Health of Citizens in the Russian Federation”, medical care is organized and provided in accordance with the procedures for the provision of medical care, which are mandatory for all medical organizations in the Russian Federation, as well as on the basis of standards medical care.

In accordance with the Appendix to the Regulation on Licensing Medical Activities (with the exception of the specified activities carried out by medical organizations and other organizations that are part of the private healthcare system, on the territory of the Skolkovo Innovation Center), approved by the Decree of the Government of the Russian Federation dated April 16, 2012, work (service ), which is a medical activity, is subject to licensing in orthopedic dentistry.

Thus, if an individual entrepreneur (IE) performs the duties of a dental technician for the manufacture of various types of artificial crowns, including metal-ceramic, simple designs of pin teeth, various designs of bridges, removable lamellar and clasp prostheses, orthodontic and maxillofacial structures, the IP must obtain a license to carry out medical activities in orthopedic dentistry in the licensing authority of the subject of the Russian Federation, on the territory of which it is planned to be carried out.