On July 1, 2015 marketing authorization requirements for Medical Devices in Ukraine have changed. The previous registration system has been replaced by a national conformity assessment to Technical Regulations based on relevant EU Directives 93/42/EEC, 98/79/EC and 90/385/EEC.

As already mentioned in the article “The renewal timetable: watch out for deadlines” Medical Devices which already obtained the registration certificate in Ukraine may be placed on the market without repeating the conformity assessment procedure. IMPORTANT: such condition ends with the expiration of the registration certificate validity and no later than July 1, 2017. Selling such Medical Devices is permitted until the use-by date expiration, which allows accumulation of commercial reserves (stock).

It is impossible to renew registration certificate or to implement any changes to devices during this transitional period.

The CE marking on the product labelling, as well as availability of documents confirming compliance with the European Directives for Medical Devices or approval of devices sale on the European markets, does not authorize placement of the product on the Ukrainian market. In fact, it is necessary to pass the national conformity procedure.

Moreover, previous registration does not facilitate this process and the results of technical, preclinical or clinical examinations do not provide assurance of conformity to Technical Regulations.

For all Medical Devices that should be put on the market from July 1, 2015 for the first time, a national conformity assessment to Technical Regulations ,as established by Cabinet Decrees of the Ministers of Ukraine №753, №754, №755 dated October 2, 2013, is required.

It should be noted that the procedure of national conformity to Technical regulations depends on Medical Devices risk class and may require the accredited Notified Bodies involvement.

One of the mandatory requirements for all classes devices and for all types of conformity procedures is the appointment of an Authorized Representative in Ukraine, if the manufacturer is not established in the territory.

The Authorized Representative is responsible for:

serving as a liaison between Ukraine Regulatory Authorities, together with users, and the manufacturer;
post-market surveillance.

Obviously the Authorized Representative in Ukraine acts in accordance with the Power of Attorney or Manufacturer’s Representative Agreement and, considering communication requirements, as well as responsibilities concerning quality and safety, reaction to complaints, it is recommended to sign between the parties a Quality Technical Agreement and a Vigilance Agreement.

Moreover, the outer packaging and/or in the instruction for use of the medical device shall contain the name and the address of the Authorized Representative. At the same time, each medical device (type/model) must be linked to only one Authorized Representative. So, if the manufacturer appoints the importer / distributor as Authorized Representative, he will become completely dependent on him. In this way, it would risk, in the event of a conflict, to not be able to market the device on the territory or to be unable to seize any possibility of multiplying sales through other distributors. Therefore, it is advisable to use a third-party and independent distribution channel.

Thema can support you with its on-site partner agency, for more information please contact us at info@thema-med.com .