Registration of medical devices: important changes in legislation

To date, the registration procedure for medical devices has been canceled and from 07/01/2015 the procedure for the compliance of medical devices with the requirements of technical regulations has come into force. Therefore, all new products are subject to this procedure.

Organization of the conformity assessment procedure, which are approved by the Technical Regulations (Decree of the Cabinet of Ministers of Ukraine No. 753 of 02.10.2013, Cabinet of Ministers of Ukraine No. 753 of 02.10.2013, Cabinet of Ministers of Ukraine No. 755 of 02.10.2013). Estet-portal.com will remind you which aspects are the main ones after the introduction of the mandatory application of technical regulations for medical devices and what are the significant changes and features of the period of transition from one system to another.

Procedure for the compliance of medical devices with the requirements of TR 

Registered products are allowed to be put into circulation without a conformity assessment procedure until the expiration date of the certificate, but no later than July 1, 2017 (whichever comes first). This is stated in the Resolution of the Cabinet of Ministers of Ukraine No. 240 dated March 23, 2016 "On Amendments to Certain Resolutions of the Cabinet of Ministers of Ukraine".

Sale is allowed until the expiration date of the product itself, which allows you to build up inventory in Ukraine and gradually meet the requirements of the new legislation.

It is not possible to extend the validity of the certificate of registration or make any changes. In this case, as for all medical devices, machinery and equipment that is put into circulation for the first time, it is necessary to pass an assessment of compliance with the Technical Regulations (PKMU No. 753, No. 754, No. 755).

The presence of the CE symbol on the product labeling, as well as documents confirming compliance with the European Directives for medical devices and the right to find the product on the EU market, does not give the right to be placed on the Ukrainian market without a national procedure. Also, the presence of a previous registration practically does not make the task easier, and the results of technical, preclinical and clinical examinations cannot be counted as confirmation of compliance with the Technical Regulations.

Affected medical devices

Features of the application of technical regulations to medical devices that have passed state registration before July 1, 2017 are shown in the table:

Medical devices:	Putting into circulation/operation	Implementation/Application
Perpetual certificate of registration or certificate expires after 07/01/2017	Can be put into circulation/operation without complying with the requirements of technical regulations until 07/01/2017	Provided that it is put into circulation / operation before 07/01/2017, it is allowed to sell / use on the territory of Ukraine until the expiration date
The certificate of registration expires on 07/01/2017	Can be put into circulation/operation without complying with the requirements of technical regulations before the expiration of the registration certificate	Provided that it is put into circulation / operation before the expiration of the registration certificate, it is allowed to sell / use on the territory of Ukraine until the expiration date

Principal differences between the previously existing state registration system and the current conformity assessment system:

• Some products have changed their status to non-medical;
• accompanying documentation required for importation and putting into circulation;
• authorities responsible for carrying out the procedure;
• mandatory appointment of an authorized representative of the manufacturer in Ukraine;
• changes in the classification of medical devices;
• lack of a unified list of documents, non-linearity of the conformity assessment procedure;
• simplification of the admission of safe products to the market;
• production checks in terms of some procedures;
• changing requirements for instructions for use and labeling;
• Market supervision of the circulation of medical devices.

The changes introduced regulate the procedure for the admission of medical devices to the market, as well as the rules for supervision in the process of subsequent circulation of products.

Compliance with the new requirements is very important for both manufacturers and their authorized representatives and other actors in the supply chain.

Estet-portal.com interviewed Peydan Alla Aleksandrovna, director of Nike-Med Ukraine LLC, the official distributor of products for plastic  and aesthetic surgery (Aqualyx, Eurosilicone, Body-Jet) in Ukraine .

Since the transition to the new registration system for medical devices directly concerns importers of products of this class, Alla Peydan explained what the consequences of the abolition of state registration of medical devices for importers, doctors, patients and the market as a whole will be:

• First of all, the changes will affect importers of drugs that have not been previously registered, as well as medical devices whose certificate is expiring;

• the need to re-submit documents to the State Service of Ukraine for Medicinal Products in order to determine the product safety class;
• mandatory application of the national mark of conformity, as well as an indication of the name and address of the authorized representative of the foreign manufacturer of medical products in Ukraine (in this case, the manufacturer must sign the appropriate distribution agreement valid for at least 5 years);
• the presence of a power of attorney of an authorized representative does not give the right of exclusive distribution and import of medical devices in Ukraine (there may be several importers of one Manufacturer);
• The owner of the Conformity Assessment Certificate is the Manufacturer of the medical device. the introduction and circulation of medical devices under valid certificates is allowed until July 1, 2017;
• if you have an indefinite certificate without going through the re-registration procedure, you can import and sell medical products before the expiration date, but not more than five years from the date of putting into circulation;
• transition to the new registration system is beneficial for large market players, and for small companies, the TR compliance assessment means high costs and little benefit;
• The new registration system eliminates the possibility of selling drugs and products without proper documentation;
• monopolization of the market, which will be entailed by legislative changes, may lead to a restriction of the choice of medical devices and an increase in prices;
• responsibility for the quality of medical products rests entirely with the official representative in Ukraine, and not with the manufacturer or doctor; an authorized representative is obliged to keep the documentation for at least 5 years (for medical devices that implant – at least 15 years) to be provided at the request of public authorities and / or a conformity assessment body;
• need to renew the obtained certificate every 5 years.

In view of the fact that technical regulations for medical devices are part of the national system of technical regulation of products, which includes supervision of safety requirements and handling on the Ukrainian market, the market supervision authority for medical devices that have passed the conformity assessment procedure is State Service of Ukraine for Medicinal Products.

According to Article 15 of the Law of Ukraine "On State Market Supervision and Control of Non-Food Products", officials of the market supervision body have the right to conduct documentary checks and examine product samples, select samples and test them, and also freely visit:

• shopping and storage space;
• where the product will be used during installation and/or commissioning;
• venues for exhibitions or product demonstrations;
• places of customs storage of products, the clearance of which is suspended as a result of control.

Alla Peydan also noted that today only companies that are completely confident in the quality and demand for the products supplied (no more than 5%) have passed the re-registration procedure.