Health Care

01/ 06/ 2016

Ukrainian Ministry of Health (MOH) Order No.361 (dated 13 April 2016) amended the Procedure for Maintaining the State Register of Medical Equipment and Devices (Procedure).

On 1 July 2015, state registration of medical devices was cancelled. On the same date the procedure of conformity evaluation of medical devices was put in place in Ukraine.

Notwithstanding the new rules, it was of utmost importance for the manufacturers of medical products to be reassured that the State Register of Medical Devices (State Register) continues its operation.

The Association raised this issue for the state health care authorities’ resolution as far back as 2014. However, the process was hampered by a wide array of other current problems in the medical devices area. In addition, manufacturers couldn’t get any information on the state authorities responsible for maintaining the State Register, so it was also one of the unresolved issues for a protracted time period.

The Association proposed that all medical devices with State Registration certificates included into the State Register as of 30 June 2015 should remain on the list until 30 June 2020, with general access to this information available for the purpose of verification.

The goal was achieved via adoption of MOH Order No.361. The Order provides the following amendments:

– The mechanism of maintaining information about registered medical devices and equipment in the State Register was established, anticipating access to this information.
– Medical devices’ certificates of State Registration should be kept in the State Register until 30 June 2020.
– The state body responsible for the maintenance of the State Register was mandated to be the State Administration of Ukraine on Medicinal Products.

We welcome the adoption of amendments anticipated by MOH Order No.361. They will reduce to zero the number of complications which could be faced by companies during circulation of their medical devices. The Association expects that MOH Order No.361 will be officially published soon.

We also express our hope for the new Government of Ukraine, for its facilitation of resolution of a great deal of problems and inconsistencies that unfortunately are a key characteristic of the medical devices area in Ukraine. Improvements in this area would be of great significance for patients and the whole medical community.

Legal background:

The CMU Resolution №240 dated 23 March 2016 introduced amendments to the CMU Resolutions No.753, No.754, No.755 dated 2 October 2013, under which the medical devices (including medical devices for in vitro diagnostics and active medical products that are implanted) that passed the procedure of state registration and started their circulation prior to the date of the mandatory application of relevant Technical regulations, are authorized for marketing until their validity is expired but no longer than five years starting from the date of their circulation, without the conformity assessment procedures and the national conformity mark as mandatory.

On 13 April 2016 the MOH Order No.361 (Order No.361) amending the MOH Order ‘On approval the Procedure of Conducting the State Register of Medical Equipment and Medical Devices’ No. 533 dated 16 July 2012 was adopted.

Order No.361 will come into force after its official publication. This legal act is being prepared for publication in the Official Bulletin of Ukraine No.41 (June 3, 2016).

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