Do I need a license for a dental laboratory? Rules for obtaining a license for a dental laboratory
I want to create an individual entrepreneur. Please clarify the need for licensing OKVED code 33.10.1 - production of artificial teethAnswer. Order of the Ministry of Health of the Russian Federation dated December 20, 2012 No. 1183n approved the nomenclature of positions for medical and pharmaceutical workers, including the position of a dental technician.
In addition, the Unified Qualification Directory for 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 job responsibilities of a dental technician: production of various types of artificial crowns, including metal-ceramics, simple designs of pin teeth, various designs of bridges, removable plate and clasp dentures, orthodontic and maxillofacial structures. A dental technician prepares dental equipment and dental laboratory equipment for work, monitors their serviceability and correct operation. Provides first aid in emergency situations. 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 a dental laboratory; characteristics of the main materials used in denture technology; manufacturing technology of dental maxillofacial prostheses and orthodontic devices; rules for the use of porcelain and metal-ceramics in denture technology; the basics of the functioning of budgetary insurance medicine and voluntary health insurance; basics of epidemiology; basics of valeology and sanology; basics of disaster medicine; basics of labor legislation; internal labor regulations; labor protection and fire safety rules.
Requirements for the qualifications of a dental technician: secondary vocational education in the specialty “Orthopedic Dentistry” and a specialist certificate in the specialty “Orthopedic Dentistry” without any work experience requirements.
In addition, the procedures for providing medical care include the standard for equipping a dental technician’s office and the 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 order of the Ministry of Health and Social Development Russia dated December 7, 2011 No. 1496n “On approval of the procedure for providing medical care to the adult population for dental diseases”).
According to Art. 37 of the Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals 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, mandatory for execution on the territory of the Russian Federation by all medical organizations, as well as on the basis of standards medical care.
In accordance with the Appendix to the Regulations on licensing of medical activities (with the exception of the specified activities carried out by medical organizations and other organizations included in 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 constitutes medical activity, is subject to licensing in orthopedic dentistry.
Thus, if an individual entrepreneur (IP) performs the duties of a dental technician for the manufacture of various types of artificial crowns, including metal-ceramics, simple designs of pin teeth, various designs of bridges, removable plate and clasp dentures, orthodontic and maxillofacial structures, the individual entrepreneur must obtain a license to carry out medical activities in orthopedic dentistry from the licensing authority of the constituent entity of the Russian Federation on the territory of which it is planned to be carried out.
DO YOU NEED OR NOT A LICENSE TO MANUFACTURE DENTAL PROSTHESES?
The answer to this question is not at all obvious, as it might seem at first glance.
Turning to the legislation “On licensing of certain types of activities” Federal Law dated 04.05.2011 N 99-FZ, we find out that licensing of medical activities is regulated by the said 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 make dentures is not needed.”
Let us analyze the existing legislation concerning the manufacture of dentures in the field of medicine, production and the work of dental technicians.
The current All-Russian Classifier of Types of Economic Activities (OKVED-2) (approved By Order of Rosstandart dated January 31, 2014 N 14-st) (as amended on February 20, 2019) The “Dental practice” grouping (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 group does not include: . A separate OKVED code is provided for this: 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: Production of medical instruments and equipment.
This grouping includes:
- production of laboratory installations, surgical and medical instruments, surgical instruments and spare parts, dental equipment and consumables, orthodontic products, dental and orthodontic prostheses
According to the All-Russian Classification of Products OK 005-93, prosthetic and orthopedic products are included in the group of medical products. Consequently, the manufactured prosthetic and orthopedic products and their parts are classified as medical products - code 93 0000.
In addition, the Law (99-FZ) establishes a requirement for obtaining a license for the production of medical equipment - code 94 0000, to which these medical devices do not apply. A dental technician does not produce medical equipment. It produces 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 products” and subgroups: 15.16 “Dental prostheses and related products” and 15.17 “Dental prostheses and related products".
Thus, the legislator is aware of the existence of such medical products as: “Dental medical products” and “Dental dentures”.
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 products, custom-made for patients, which are subject to special requirements for the appointment of medical professionals and which are intended exclusively for the personal use of a specific patient, are not subject to state registration." Thus, the legislator does not require state registration of activities for the manufacture of dentures.
The above suggests that a dental technician does not require a license to manufacture dentures. It's not entirely clear.
There are options when a license is needed and when it is not needed.
Let's look at both. And both of them are correct.
Option 1: IF the production of dentures is carried out by dental technicians.
In the Nomenclature of Specialties of Specialists with Secondary Medical and Pharmaceutical Education in the Healthcare Sphere 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 (MSKZ-08). The All-Russian Classifier of Occupations” highlights occupation No. 3214 “Dental technicians and prosthetic technicians.” Dental and prosthetic technicians can make dentures, crowns and bridges. Their responsibilities include: including: - production of full and partial dentures, aligners, crowns, metal clamps, inlays, bridges and other devices;
The duties of a Dental Technician include: Production of artificial crowns, including metal-ceramics, simple designs of post teeth, designs of bridges, removable plate 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 Directory for positions of managers, specialists and employees, section “Qualification characteristics of positions of workers in the field of healthcare”). In order to occupy 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 02/10/2016 N 83n “On approval of qualification requirements for medical and pharmaceutical workers with secondary medical and pharmaceutical education”).
Until April 30, 2012, Decree of the Government of the Russian Federation of January 22, 2007 N 30 “On approval of the Regulations on licensing of medical activities” was in force, which detailed that the list includes services performed in the implementation of pre-medical, outpatient, inpatient, emergency and emergency specialized, high-tech , sanatorium-resort medical care.
In the current Decree of the Government of the Russian Federation dated April 16, 2012 N 291 “On licensing of medical activities,” there is no detail regarding pre-medical medical care.
This is due to the fact that Art. 33 of the Federal Law 323 “On the fundamentals of protecting the health of citizens in the Russian Federation”, which entered into force on January 1, 2012, considers primary pre-medical 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-medical care.
Organizations that manufacture dentures using dental technicians must obtain a license. Dental technicians with secondary vocational education and a valid certificate in the specialty “Orthopedic Dentistry” can be hired for a position in such an organization. The organization is considered medical.
Option 2: IF the production of dentures is carried out NOT by a dental technician, but by a specialist in the field of computer technology and production.
Let's imagine a workshop for the production of artificial teeth for removable denture sets. Or a factory for the production of orthodontic trainers. Or a company that produces mouth guards (aligners) to correct your bite.
Or a production machine shop with dozens of milling machines that sharpen titanium abutments, clasps, titanium bases day and night...
In another workshop, models, spoons, aligners, temporary crowns are printed on 3D printers...
In the third room there are staff - exclusively computer modeling specialists who have nothing to do with medicine. They receive STL files for modeling from doctors and clinics. And they work with them programmatically.
They are really good at working with 3D graphics. And it makes no difference to them what to model and send for printing or milling: a set of toy soldiers or dentures modeled in a CAD program.
And so they calmly model their prosthetics, saw, and print.
They work officially under contracts, receive payment by bank transfer, pay salaries, funds and taxes.
Tell me, does this description sound like a dental laboratory? Not particularly, really. In reality it looks more like a factory.
Do they have the right to manufacture medical products at the factory in 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 products” which distinguishes: group 15 “Dental medical products” and subgroups: 15.16 “Dental dentures and related products” and 15.17 “Prosthetics dental and related products" distinguishes them as an independent product of production.
IMPORTANT! Please note - this is not the nomenclature of medical SERVICES by order of the Ministry of Health of the Russian Federation 804n, but the nomenclature of medical DEVICES 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 manufacture them in the second option are not medical workers and do not provide medical services, as is the case when a dental technician with a medical education performs the SAME work. They are anyone - a 3D designer, a CNC machine programmer, a printer maintenance worker...
And it doesn’t have to be a huge factory for the production of medical devices. And a simple small laboratory can be designed like this, the main thing is to know how to do it correctly.
Main conclusions:
1. A dental technician is a HEALTH WORKER. Therefore, the manufacture of medical products in the form of dentures by his own 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 medical worker under the medical OKVED.
3. To make dentures as a profession "Dental Technician" it is indeed REQUIRED to obtain a medical license for ZTL. The activities of a dental laboratory in the Russian Federation are subject to licensing as medical. Definitely so.
4. The manufacture of dentures may not be medicine, but manufacturing. 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, don’t forget!).
5. If the manufacture of dentures is formalized specifically as a production, then you need to be able to create and actually defend to the inspectors a large package of documentation that distinguishes this production from medicine and a dental laboratory.
6. If during the inspection you are unable to document that you are not engaged in medical activities (and the line is very thin and only very competent specialists in medicine and law can actually translate this into documents), then you will be charged with carrying out activities without a license with everyone the resulting legal consequences. Which dental technicians for some reason prefer not to know about. But if you are caught and accused, this is what will happen:
Administrative punishment:
Code of Administrative Offenses of the Russian Federation
Article 14.1. Carrying out business activities without state registration or without special permission (license)
Punishment:
2. Carrying out business activities without a special permit (license), if such a permit (such license) is mandatory (mandatory),
entails the imposition of an administrative fine
- on 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 we get caught, well, we’ll pay a fine and that’s it. But read this carefully: "... with confiscation of manufactured products, production tools and raw materials or without it."
To put it in human language, everything you work with is CONFISCATED - the oven for pressing ceramics, the foundry, all the brushes and masses, the dental motor, etc. The measure is clear - to prevent relapse, so that after paying the fine you will not continue to violate.
So calculate how much it will cost.
Do you think that's all? You are wrong!
There is also a CRIMINAL penalty for this. And even its own special article:
Criminal Code of the Russian Federation, Article 235.1. Illegal production of medicines and medical devices(introduced by Federal Law dated December 31, 2014 N 532-FZ)
1. Production of medicines or medical products without special permission (license), if such permission (such license) is mandatory (mandatory), -
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. In this article, large amounts are defined as 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 crime
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 you worked in a group like this in the laboratory (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 completely alone as an individual entrepreneur, but the investigation has proven that you receive income from such work in the form of a large amount ( In this article, a large amount is recognized as the cost of medicines or medical devices exceeding 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? They earned only a stolnik - they went to prison for 8 years, paid a criminal fine of 3 million, and on top of that, they confiscated all the dental equipment... How do you like the prospect?
Well, dear technicians, do you still want to continue working without a license without regard for knowledge of the laws and the help of professionals, proudly pointing at everyone with code 32.50 and considering this the main argument of defense? Then they will come for you sooner or later, it’s a matter of time.
There are no freebies or easy ways in our country. If you want to save on a license and avoid checks in medicine, you need to pay professionals for proper registration of your activities as a production. Don't do this yourself. Either get a medical license, or do the production by those who understand this. Otherwise - see above...
The article uses materials from the website http://medyurist.pro from the publication of Kirill Gennadievich 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.
Dentistry licensing
3. Conclude an agreement with us
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!
Why should you contact us:
- 100% obtaining a license within 45 days
- visit of a specialist to the site for assessment and free consultations
- We carry out the entire cycle of work on a turnkey basis, providing a European level of service, performing our work with minimal time costs, without distracting you from your main activity
- We will not only develop the project, but also monitor it at all stages of implementation
7(495)970-14-90 ext 1400 or by writing an email to
LICENSING OF MEDICAL ACTIVITIES
Today, the StomExpert Company provides a full range of services for obtaining a license for all types of medical activities.
Why should you contact us:
- 100% obtaining a license within 45 days
- visit of a specialist to the site for assessment and free consultations
- visit of a specialist to the site during an inspection by the licensing authority
- We carry out the entire cycle of work on a turnkey basis, providing a European level of service, performing our work with minimal time costs, without distracting you from your main activity
- We will not only develop the project, but also monitor it at all stages of implementation
With us you can do:
1. LICENSING OF DENTISTRY (INCLUDING X-RAY OFFICE)
The cost of a dental license (including an x-ray room) is from 100,000 to 200,000 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 for dental services as soon as possible.
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 only a few companies undertake this procedure. As a result, the licensing process drags on for years.
How to obtain a dental license?
To obtain a license to practice dentistry, it is enough to:
1. Arrange a meeting in our office 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!
2. LICENSING OF A DENTAL LABORATORY
The cost of licensing a dental laboratory starts from 50,000 rubles.
If you have an operating dental laboratory or are planning to open a dental laboratory, then having a medical license for a dental laboratory is a prerequisite for running this business. A license for a dental laboratory is issued once and is currently unlimited.
To obtain a dental laboratory license, it is enough to:
1. Arrange a meeting in our office 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!
License validity period: unlimited.
3. LICENSE FOR SERVICING MEDICAL EQUIPMENT
The cost of licensing for the maintenance of medical equipment is from 150,000 to 215,000 rubles.
To carry out repairs and maintenance of medical equipment, a medical license for the maintenance (repair) of medical equipment is required. A medical license for servicing medical equipment is currently issued once and is unlimited.
Why should you contact us:
- 100% obtaining a license within 45 days
- visit of a specialist to the site for assessment and free consultations
- visit of a specialist to the site during inspection
- we provide all the necessary equipment
- We carry out the entire cycle of work on a turnkey basis, providing a European level of service, performing our work with minimal time costs, without distracting you from your main activity
- We will not only develop the project, but also monitor it at all stages of implementation
- More than 100 companies have already entrusted us with obtaining a license
7(495)970-14-90 or by writing an email to
Rules for obtaining a license for a dental laboratory 1687 1126 Medical license Medical license https://site/wp-content/uploads/2019/01/Fotolia_Team-labo.jpg 29.01.2019 26.07.2019Prosthetics is an important professional procedure for any dentist. This type of service must be carried out in a specially equipped office - a dental laboratory.
A sparkling smile has always been an important part of a person, and therefore its formation always brings income to the doctor. But it is worth considering the fact that this popular procedure is quite expensive. This is due to the creation of appropriate working conditions for personnel and the laboratory itself. High demands and their unwavering adherence are the only way.
According to the laws of the Russian Federation and government Decree No. 291, orthopedic dental services are subject to mandatory licensing. Dentures are created in laboratories that relate to this type of dental services, and therefore they also require a license for their type of activity.
Requirements necessary for the implementation of the activities of a dental laboratory
To carry out procedures for installing dentures, it is necessary to have an appropriate room that has an inspection certificate from the Ministry of Emergency Situations, and the conditions in it do not contradict sanitary standards. It must contain specialized equipment and qualified personnel with experience in this field.
It is especially worth noting that the area of the premises directly depends on the range of services provided.
List of documentation required to open a dental laboratory
- Statement of the established form:
- documents on the right of ownership of the premises used;
- act on the inspection of the sanitary and epidemiological service;
- documents for the equipment and materials used with a registration number for each;
- contract for maintenance of instruments and equipment;
- documentation? confirming the education of employees and the chief physician;
- The latest edition of the Charter and constituent documents;
- photocopies: extracts from the unified state register of legal entities, TIN and OGRN, statistics.
Defects, or a shortage or error in at least one of these documents, may cause a refusal to obtain a license from the licensing authority.
The main factors determining the choice of a performer to obtain a license
In order not to make a mistake in choosing a performing company, you should familiarize yourself with the following indicators:
- the company's experience in this area;
- specialized area (it can be either purely medical or have multitasking);
- availability of specialists and experts in the required profile;