A business entity in medical practice who intends to
open a medical laboratory must:
- in the absence of a license to practice medicine, he must obtain it where
will be including the specified laboratory diagnostics.
- in the case of a medical license, it is necessary to make changes to the current
a license to add laboratory diagnostics to
In accordance with the list of types of economic activities that are envisaged
Article 7 of the Law of Ukraine "On Licensing of Types of Economic Activity"
medical practice is subject to licensing:
in medical specialties and specialties of junior specialists with
medical education, the list of which is approved by the Ministry of Health;
by type of medical care (emergency, primary, secondary (specialized),
tertiary (highly specialized), palliative medical rehabilitation)
at the place (s) of its production, which (which) are indicated in the application for receipt
license and in the documents that were attached to it (taking into account the
changes submitted by the licensee to the licensing authority).
If a decision is made to open a laboratory, the subject
management must know the requirements that must be observed, and
exactly:
- a clinical laboratory cannot be a walk-through;
- outpatient clinical institutions where material is collected,
should place rooms for receiving analyzes at the lobby group
premises;
- if the laboratory contains rooms for microbiological
research or AIDS research laboratory, such premises should be
isolated from other rooms, while the entrance to such rooms must be
organized externally;
- laboratories cannot be located in a residential area, but
can be located in an annex to a residential building, provided that between
laboratory and living quarters are non-residential.
standard established norms for laboratory facilities
such:
- Washing room - about 14 sq. m.

- Laboratory - about 30 sq.m.
Of course, when obtaining a license for clinical research, the laboratory must
be equipped with equipment provided for by licensing requirements, and employees
laboratories must have specialized education.
The staff should consist of several laboratory assistants (junior specialists with
medical education), which will conduct research under the supervision of a physician
a laboratory assistant with a specific specialization.
When you have the above requirements, you can proceed to
main stage: ACCREDITATION.
Accreditation of medical laboratories is the recognition of their technical
competence in accordance with the requirements of standards, the ability to perform a certain
kind of task and conduct research.
In Ukraine, accreditation is carried out by the National Accreditation Agency in
Ukraine, which checks for the conformity of the activities they carry out
standard DSTU EN ISO 15189: 2016, as well as regional and international
standards - ILAC and IAF, EA.

PERIOD of accreditation is from 2 to 4 months.
Laboratory ACCREDITATION procedure
The applicant (in person or through a proxy) submits to the National
accreditation agency of Ukraine (NAAU):
- letter of request for accreditation;
- request for a registration number;
- application for accreditation of the CAB (conformity assessment body);
- a certified copy of the Articles of Association of a legal entity or other
title document;
- regulations on the laboratory;
- a certified copy of the Certificate of state registration of a legal entity
(In the presence of);
- a certified copy of an extract from the Unified State Register;
- a certified copy of the added tax payer registration certificate
value or extracts from the Register of Value Added Tax Payers;
- a questionnaire;

- passport of a medical laboratory;
- project;
- areas of accreditation;
- management with a full set of procedures in accordance with DSTU EN
ISO 15189: 2015;
- data on the location of the applicant's premises in the city (plan / extract
/ A copy of the city plan);
- a plan of the laboratory premises;
- copies of diplomas or other documents confirming qualifications
personnel in accordance with Form 6 of the Medical Laboratory Passport;
- copies of the originals of the test reports;
- questionnaire;
- data on the assessment of the suitability of the methods.

After the received documents NAAU
examines documents and
issues the corresponding act, after which
the check is already in place.
Based on the results of the check, in case of successful completion, the group leader
of accreditation auditors draws up an Onsite Assessment Report with recommendations for
accreditation or refusal of accreditation by issuing a corresponding certificate.
The certificate issued by the NAAU is valid for three years. Six months before graduation
this period, the medical laboratory must submit a request for
re-evaluating its performance.
One of the main activities of the Lawyer Association "Novakovskaya
and partners ”is an activity in the field of medical law.

The lawyers of our association, having considerable experience in these matters, will help
You will prepare a full package of documents and SUCCESSFULLY go through the procedure
MEDICAL LABORATORY ACCREDITATION.