Medical equipment needs regular and quality service. Typically, this service is offered by companies specializing in the sale and installation of such equipment. Service should be performed exclusively by organizations that have an official license for this activity. A license for the maintenance of medical equipment is issued indefinitely, but only if the organization has certain documentation. The recipients of the license are subject to numerous and specific requirements.
Why do i need a license?
Permission is required for the maintenance of medical equipment by law firms that have the necessary parameters to complete this process. It is issued only by specialists of Roszdravnadzor. The documentation is provided indefinitely, but once every three years, authorized persons check the work of the company that has received permission.
Often, due to identified violations, the license is revoked, so the company loses the right to engage in the maintenance of medical devices.
Rules for registration
Medical equipment regularly needs specific service, since it is with its help that significant breakdowns can be prevented in an unforeseen situation. Therefore, medical organizations must enter into agreements with other companies involved in the repair, maintenance or installation of equipment. These firms must be licensed for the maintenance of medical equipment. It is issued subject to the following rules:
- only legal entities can apply for such a permit;
- you will have to apply for the document to the department of Roszdravnadzor;
- a license is issued within 45 business days;
- for its receipt you will have to pay a fee of 7.5 thousand rubles.
Employees of the organization must have the necessary education and skills to perfectly cope with the tasks.
What work can only be done with a license?
Obtaining a license for the maintenance of medical equipment is necessary to implement the following actions:
- installation and commissioning of equipment;
- preparation of equipment for launch or continuous use;
- carrying out repair work of varying complexity;
- instrument maintenance, which is implemented on the basis of a pre-arranged schedule, since such actions can prevent complex breakdowns;
- control over the technical condition of different elements.
Any medical organization must conclude a formal contract with a service company. Initially, she must make sure that the selected company has a license for such work. If this permission is absent, then the contract cannot be signed.
Where is it issued?
A license for the maintenance of medical equipment is issued only at the Roszdravnadzor department. It is the specialists of this organization that constantly monitor the activities of organizations that have received a license.
Before issuing a permit, specialists must make sure that the company meets certain standards and requirements, and can also cope with the tasks. The organization must have qualified employees and specialized equipment for this.
How to get a license for the maintenance of medical equipment?
This permission is considered quite complicated in design.For this, a certain set of documents is pre-assembled, and special checks are also carried out. Practice shows that these actions are really complex and time consuming. Therefore, often firms prefer to use the help of consultants offering online documentation preparation services.
A license for the repair and maintenance of medical equipment is issued in the following sequence of actions:
- initially, the company draws up a statement in the form of Roszdravnadzor;
- the necessary package of documents is prepared and transmitted to the employee of the state institution;
- the representative of the company fills in special forms directly at the Roszdravnadzor branch;
- Further, all documentation is carefully checked by specialists of a state institution;
- if there are no errors or inconsistencies in the documents, a positive decision is made, therefore, the company receives a license, and this documentation is valid indefinitely.
Most difficulties arise with the preparation of the necessary documentation. To do this, it is important to confirm that the company has qualified specialists who can cope with the maintenance of medical equipment.
What documents are prepared?
Companies involved in servicing medical devices should figure out who issues the license for the maintenance of medical equipment, and which documents will need to be prepared for this. The main documentation includes:
- statistics codes obtained from Rosstat;
- constituent documentation of the company;
- work books, labor contracts and documents on the education of company employees, and with the help of these documents the company will be able to prove that it employs specialists who can service specialized devices used in the medical field;
- extract from the Unified State Register of Legal Entities, which will have to be ordered immediately before contacting Roszdravnadzor;
- documentation for the premises where the company’s office is located, and it can be represented by an extract from the USRN if the object belongs to the organization, and a lease can also be used;
- receipt confirming payment of duty;
- documents for all equipment that will be used for maintenance or repair of medical devices, and this equipment should be new, modern and safe for use;
- expert opinions received from the fire inspectorate, SES and other regulatory authorities, and they must confirm that the existing premises and equipment comply with the basic requirements for the planned activity.
Usually, the authorized representative of the company is responsible for registering a license, therefore a citizen must have a correctly drawn up and notarized power of attorney. Additionally, employees of Roszdravnadzor may require other documentation when appropriate.
What documents are issued after a positive decision?
After checking the documentation, Roszdravnadzor employees decide on the possibility of issuing a license for the maintenance of medical equipment. If it is positive, then the specialists of this state organization prepare the following papers:
- an order to issue a license, which is signed by the head of the department of Roszdravnadzor;
- a new permit is registered in a special register of licenses;
- a direct license is formed in the established form, for which a special form is used, protected from forgery.
The permit may be issued in electronic form, but this must be indicated when preparing the application, which is transmitted with other documentation to the office of the registering authority.Within three days from the date of signing and registration of the license, this documentation is transferred to the company representative. In addition, permission may be sent by mail, for which a letter of receipt is used. If an electronic license is ordered, it is sent to the applicant using specialized means of communication.
Information on the issuance of permits will certainly be published on the official website of Roszdravnadzor. Therefore, each medical organization that concludes a service contract with a particular company can check whether it has a license on this site. Only with such permission are employees of the enterprise allowed to service medical equipment.
Reasons for refusal
Often, companies planning to service certain types of medical equipment subject to licensing are denied permission. This decision may be due to various significant reasons:
- in the documentation submitted for consideration, false information is revealed;
- the applicant does not prepare all the necessary documents;
- during the verification process, it is revealed that the applicant does not meet the licensing requirements;
- the company does not have employees who have the necessary education and skills to cope with complex and specific work.
If the grounds for refusal are non-compliance with the requirements of the licensing authority, then a verification act is attached to the written decision. A notice of a negative decision may be issued in writing or sent to the applicant using information and communication tools.
License Terms
Documentation verification procedure is carried out within 45 days. Therefore, companies that submitted an application with other documentation to the Roszdravnadzor branch should prepare for a long wait.
During this period, not only the documents received from the applicant are checked, but also the check is carried out. The main goal of this process is to obtain information about the technical equipment of the company, as it should cope well with the tasks. If any discrepancies or problems are identified, a negative decision is made.
What difficulties may arise?
In the process of obtaining a license, companies usually face the following difficulties:
- it is impossible to pass the audit, as the company staff does not have qualified employees or there is not the right amount of funds to purchase specialized equipment;
- the applicant cannot independently collect all the documentation;
- Various errors are made when filling out an application or other forms.
You can cope with such difficulties on your own or through the services of specialized companies.
What work is done as part of the maintenance of equipment?
If the company receives a license, then it can deal with the maintenance of medical devices. To do this, a set of specific actions is performed, which include:
- control that the equipment in accordance with its parameters declared characteristics in official documents;
- the study of the health of the main components of the devices;
- filling in special operational documentation, for which employees of the company take into account certain rules;
- studying the condition of cables, fasteners, or other connections;
- equipment diagnostics;
- replacement of various consumables and items.
All these actions should be performed only by experienced professionals who have the necessary equipment and tools.
Conclusion
Each company offering medical device maintenance services must have an official license.To obtain it, it is required to prepare certain documentation, hire experienced specialists, as well as prepare equipment and tools for the planned activity.
The license is granted on an unlimited basis, but may be revoked if violations are detected during inspections. To receive it, a fee of 7.5 thousand rubles is paid, and also work permits are issued in other state instances.