Medical professionals are engaged in an extremely responsible field of activity. The life and health of people largely depends on them. Therefore, the state, for its part, must monitor the highly qualified specialists who have chosen these specialties.
Currently, Russia has opened many private organizations that offer various medical services. To carry out activities, they must be licensed. Through this document, the state guarantees that people will receive qualified assistance by contacting such institutions. About how the registration and renewal of a license for medical activity is carried out, is described in detail in the article.
The legislative framework
Permits are issued on the basis of Government Decision No. 291 “On Licensing of Medical Activities”. This document provides the main provisions in accordance with which the issuance of permits for the opening of a private medical institution is regulated. In addition, the clearance is based on the following legal acts:
- Clause 2 of Article 54 of the Civil Code of the Russian Federation.
- Law "On the licensing of certain types of activities" No. 99-ФЗ.
- Ministry of Health and Social Development clarifications on obtaining permits.
- SanPin 2.1.3.2630-10.
Features
A license is an authorization document that allows specialists to engage in certain types of activities. To receive it, the organization must be checked for compliance with the requirements established by law. At the same time, equipment is tested, personnel qualifications are checked.
Only after receiving the relevant document, the organization can begin to work. The same principle applies in the event of a renewal of a license for medical activity.
Licensing is obtained for certain types of practices. In this case, there are circumstances in which they may deprive the right to engage in medical activities. These include non-compliance with established requirements, closure of establishments and others.
The process of obtaining a license includes 5 stages:
- Submission of documents for consideration.
- Preparation of expert opinions.
- Object research.
- Preparation of an opinion after checking the premises of a medical institution.
- Decision-making.
- Entering information into the Unified Register and issuing permits.
When permission is needed
Registration and renewal of a license for medical activity is carried out in relation to organizations engaged in the following types of medical services:
- Providing first aid, including specialized (for example, resuscitation of newborn children).
- Primary care before arriving at a medical facility.
- Treatment carried out in a spa setting.
- Conducting medical examinations, examinations, examinations.
- Conducting activities to survey the sanitary-epidemiological conditions and issuing relevant conclusions.
- Tissue and organ transplantation, blood transfusion.
- Other activity.
Currently, many organizations are open that are not formally related to medical institutions. For example, these are beauty salons, where they not only pierce the ears, but also inject them deep under the skin. Such organizations must be licensed, as they provide services that are equivalent to medical.
Individual cases
To specific types for which registration and re-issuance of a license for medical activity is required, include the following:
- Therapeutic help when calling home.
- Dental services (conventional and orthopedic).
- Gynecological and obstetric services.
- Diagnostics in the laboratory.
- The work of nurses.
- Physiotherapy exercises and dietetics.
- Different types of diagnostics.
- Cardiology.
- Narcology.
- Sexopathology.
- Parasitology.
- Cosmetology.
- Traumatology.
A complete list of licensed activities is contained in Order No. 121 of the Ministry of Health of the Russian Federation.
Requirements
There are different requirements in accordance with which the functioning of the organization. These include the established conditions for:
- Premises.
- Equipment.
- The staff.
Let's consider each of them separately.
The building where the relevant services are provided should be officially leased or owned by right of ownership. It must meet the following requirements:
- Therapist's office - have an area of at least 12 square meters.
- A gynecologist’s office - at least 18 square meters, as well as a treatment room with an area of at least 24 square meters.
- Psychotherapist’s office - at least 18 square meters.
- Each medical office should be equipped with sinks with water. The floor must be treated. The best options are laminate or linoleum.
The following requirements are imposed on equipment:
- The organization must have a special magazine for equipment, which indicates the numbers and brands established by the manufacturer.
- There must be permits for the use of TO.
- Passports
- Warranty cards.
- Certificates of conformity obtained for existing equipment.
- Certificate of registration.
- The conclusion of the sanitary service.
- Separately, a contract for technical and warranty service is concluded for each equipment.
Employees must have specialized education. The leader should be a specialist who has higher education and at least 5 years of work experience. Once every 5 years, he must send medical workers to professional courses for continuing education. Each specialist checks the following documents:
- Diploma of graduation from a specialized institution.
- Medical book.
- Order of appointment.
- Instructions for the performance of duties.
- Employment contract.
An agreement is concluded with the head physician, and a corresponding order is issued about this. The minimum length of service of the head physician, as well as the head of the clinic, is 5 years in the relevant specialty.
Check
Before issuing a license, the authorized bodies check all documents, premises, as well as specialists. No inaccuracy is allowed in the documents. The premises must have dimensions not less than the established minimum dimensions. The equipment is provided with supporting documentation and certificates of compliance. The staff must have the necessary education, documented.
List of required documents
Registration of a license for medical activity begins with the submission of a package of documents, which include the following:
- Statement of established form.
- Extract from registers about the organization.
- Constituent documents and charter.
- INN
- A receipt confirming payment of state duty.
- Documents establishing the right to use (or property) the relevant premises.
- Conclusion of fire service.
- Contract for the provision of waste management services (medical).
- Conclusion of the sanitary and epidemiological service.
- Information letter from the Federal State Statistics Service on the registration in the Register.
Permission is issued in perpetuity.However, there are often situations in which it is necessary to reissue a license to carry out medical activities. In this case, the package of documents may be minimal or almost the same as that required during the initial execution.
Grounds
An application for renewal of a license for medical activity is submitted in the following cases:
- Change of jur. status, for example, when an organization was transformed into another legal entity, or several companies merged into one (merger), or branches were opened.
- Details have changed.
- The list of services has changed.
- The address of the room where the medical services are provided has changed.
Ways
As you can see, the reasons for re-issuing a license to carry out medical activities are of a different nature. Some of them are insignificant (for example, the name of the organization). Others require careful preparation (for example, the need to include additional services).
In the first case, the easiest way to reissue a license for medical activity. Documents for this will require a little. Among them:
- Statement.
- A receipt with a paid state duty.
- The original license obtained earlier.
The authorized state body for the consideration of this issue by law is given a period of 10 days. During this time, documents are checked and a decision is made.
In the second case, in addition to the application for renewal of the license for medical activity, a wider list of documents will be required. These include the following:
- Documents confirming the right to lease or property.
- Conclusion of the sanitary and epidemiological service.
- Necessary documentation for equipment and medical devices.
- Documents for employees (diplomas, work books).
- Duty paid receipt.
- Original license.
In this case, the period for renewal of the license for medical activity will be one month. In addition to documentary verification, specialists carry out an unscheduled departure at the address of the organization. Thus, the procedure is similar in nature to the initial execution of permits.
Conditions
Depending on the applied method of renewal, it is necessary to initially prepare in such a way as to meet the necessary conditions. Among them are the following:
- The organization must have a room for medical activities that meets established standards and requirements.
- All necessary instruments and equipment, duly registered, must be available.
- Managers and other senior officials must comply with stringent requirements. This is a certain experience, as well as the presence of a certificate confirming professional qualifications.
- The staff should work to ensure the maintenance of equipment and instruments in good condition. If there are none, then agreements are concluded with organizations that have licenses to carry out the relevant work.
Where is the application filed?
The issuance of permits, both for registration and for renewal of a license for medical activity during the reorganization, merger, change of details, the provision of additional services and in other cases, is carried out by Roszdravnadzor. Its units are available in each region. The corresponding application is submitted to the unit at the location of the premises.
Conclusion
According to the law, several years ago it became possible to obtain permission without indicating the final date. In this regard, the renewal of a license for medical activity for an unlimited period may be carried out. However, this is not at all a guarantee that the permit will always be valid. For example, in case of violations of medical activities, the license may be suspended.And if they are not eliminated, then in the subsequent permission will be withdrawn.
The procedure in question is carried out for various reasons. But regardless of this, the corresponding state duty for renewal of the license for medical activity must be paid. After taking the necessary measures and entering the data into the register, the organization has the right to provide its services.