Activities of working group on medical devices within State Administration of Ukraine on Medicinal Products

Within State Administration of Ukraine on Medicinal Products there is a working group on medical devices (hereinafter referred to as “Group”), which consists of representatives of agencies, specialized public organizations, distributors, importers and manufacturers of medical devices. Updated personal staff of the Group is published via link.

As for today Group work is focused on three drafts legal acts, which in combination intend to ensure proper functioning of conformity assessment procedures with new Technical regulations, namely:

- draft resolution of the Cabinet of Ministers of Ukraine «On amendments to certain Resolutions of the Cabinet of Ministers of Ukraine»;

- draft order of the Ministry of Healthcare of Ukraine “On approval of the Procedure for introduction into circulation and / or operation of certain medical devices, which the requirement of Technical regulations are nor fulfilled for, but the use of which is necessary for the interests of healthcare and life of a particular»;

- draft order of the Ministry of Healthcare of Ukraine “On approval of the organization of conduct and requirements for conduct of clinical trials of medical devices and active medical devices that are implanted».

According to the first draft it is expected to amend the Procedure for state registration of medical equipment and medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine of November 9, 2014 № 1497, and to p. 2.1. of the Resolutions of the Cabinet of Ministers of Ukraine, which Technical Regulations are approved by.

As for today under paragraph 3 of the Procedure for state registration of medical equipment and medical devices, approved by the resolution of the Cabinet of Ministers of Ukraine of November 9, 2014 № 1497, state registration of medical devices is carried out by the State Administration of Ukraine on Medicinal Products on the results of the examination and if necessary test conducted by the expert institutions.

By changes, in particular, it is intended to expand the list of the state registration order of medical devices. Thus, the state registration of medical devices also may be carried out in case of prior fulfillment of procedure of conformity assessment, which is confirmed by valid documents issued by the conformity assessment bodies. Hence, there are two procedures: import of medical devices on the customs territory of Ukraine by its certificate of state registration and simultaneous procedures of compliance assessment with new Technical Regulations. At the same time, the selection procedure of state registration is carried out by the applicant.

However, under this draft it is also planned to amend p. 2.1 of the Resolutions of the Government, which Technical Regulations are approved by, which was introduced by the resolution of Cabinet of Ministers of Ukraine of 27 May 2014 р. № 181 "On Amendments to certain resolutions of the Cabinet of Ministers of Ukraine". In particular, it is suggested to establish that introduction into circulation and / or operation of medical devices that have passed state registration, included into the State Register of medical equipment and medical devices and are allowed for use in Ukraine is permitted without passing conformity assessment procedures and labeling with national mark of conformity.

According to the second draft it is suggested to approve Procedure for introduction into circulation and / or operation of certain medical devices, which requirements of Technical regulations are not fulfilled for, but the use of which is necessary for the interests of healthcare and life of the individual. In fact, this document duplicates provisions of Procedure on import on the territory of Ukraine of unregistered medical equipment and medical devices, approved by the Ministry of Health of Ukraine of November 30,2012 № 979, and in the long term after the termination of the state registration of medical devices is going to replace it.

Thus, some medical devices may be imported on the territory of Ukraine or introduced into circulation and / or operate on the territory of Ukraine:

1) to participate in assistance programs of international cooperation under international treaties, etc. .;

2) in case of natural disasters, accidents, epidemics and epizootics, environmental, technological disasters, military operations and others. (by separate decision of the Cabinet of Ministers of Ukraine adopted pursuant to law);

3) in order to preserve the health of the individual.

To obtain a permit the applicant State Administration of Ukraine on Medicinal Products shall submit an application indicating the purpose of introduction into circulation and / or operation of certain medical devices, their name, quantity, name and address of the manufacturer, the list of relevant documents. Ground for refusal to introduce into circulation and / or operate on the territory of Ukraine of certain medical devices is defining of danger of such products. As a result of processing of documents, submitted by the applicant, State Administration of Ukraine on Medicinal Products provides the applicant a permit in the prescribed form.

Accordingtothethirddraftit is suggested to approve Procedure of the organization of conduct and requirements for conduct of clinical trials of medical devices and active medical devices that are implanted, which defines the procedure for obtaining permission to conduct clinical trials and sets the requirements for conducting clinical trials of medical devices and active medical devices that are implanted.

Thus, in case of manufacturing of medical devices and active medical devices that are implanted, intended for clinical trials, the manufacturer or his authorized representative in Ukraine must submit an application to State Administration of Ukraine on Medicinal Products, concerning medical devices of special purpose and list of documents, determined by this Procedure, in triplicate translated into Ukrainian.

To evaluate the applications State Administration of Ukraine on Medicinal Products appoints staff and, if necessary, freelancers, under the evaluation of whom a report on the completeness of the submitted materials and the possibility of clinical trials is issued. State Administration of Ukraine on Medicinal Products provides a report for the assessment to the expert advisory body on clinical trials, under the results of which a decision on the possibility of clinical trials makes start is made. Grounds for refusal to conduct clinical trials of medical devices are the following:

- Provision of incomplete documentation necessary to make a decision about clinical trials by the applicant;

- Provision of false information by the applicant;

- Justification for the refusal from all available clinical bases to conduct clinical research of this medical product.

A refusal to conduct clinical trials may be appealed in accordance with legislation.

The above draft legal acts are just previous documents that are subject to change in the framework of the Group.

Taking into account results of Group’s work State Administration of Ukraine on Medicinal Products as central executive authority accountable and controlled by the Cabinet of Ministers of Ukraine, prepared documents will be submitted via Minister of Healthcare to the Ministry of Health of Ukraine for consideration, and then finalized documents will be submitted for public discussion by publishing on the web-site of the Ministry of Health of Ukraine, where interested persons (companies concerned, specialized NGOs) should provide their suggestions and comments.

It should be additionally mentioned that next meeting of the Group is tentatively scheduled for September 25, 2014, wherein in particular amended versions of the abovementioned drafts will be discussed.