After the entry into force of new medical device regulations in the Ukraine, foreign manufacturers were faced with a number of procedural questions. One of these questions is about the authorized representatives (AR) functions, powers and duties.
Improve Medical – the conformity assessment body based in Ukraine kindly agreed to clarify most actual aspects about AR. Let’s have most frequent questions answered in this post:
- Who may be the authorized representative for foreign medical device manufacturers in Ukraine?
According to of the Technical Regulations (cl. 2.13) the AR in Ukraine may be:
- legal person – a resident of Ukraine;
- natural person with status of an entrepreneur, a citizen of Ukraine;
- representational office of foreign manufacturer of medical devices in Ukraine;
- distributor of foreign manufacturer of medical devices in Ukraine.
- What documents are needed for the AR to undertake these obligations?
AR is appointed on the basis of an agreement (contract) or an arrangement in which it is necessary to specify duties and functions to be undertaken by the AR. As a rule these functions are as follows:
- to initiate on behalf of the manufacturer the assessment of the conformity to the Ukrainian technical regulation and to the QMS;
- to perform all related payment;
- to provide translation of technical documentation;
- to prepare package of documents for assessment procedures;
- to obtain certificates of conformity assessment from the certified bodies;
- to store the technical documentation and all certificates;
- to report to the manufacturer about adverse events/side-effects, found out as the result of the use of his products;
- to inform potential customers about technical and consumer properties of the manufacturer’s products;
- to inform the manufacturer about the amendments in Ukrainian regulations.
The right of the AR to reassign to the third parties the powers given to him by the manufacturer shall be also stipulated – but along with this, the AR bears the responsibility for actions of the third parties as for his own.The validity period of this contract is usually determined as not less than five years.
- What functions shall perform the Authorized representative?
The main function of the AR is the representation of interests of foreign representative in the territory of Ukraine and communication between the foreign manufacturer of medical products and Ukrainian market. It shall be understood however, that the term «Ukrainian market» means not so much marketing outlet itself, as bodies of assessment of the conformity, monitoring bodies, fiscal bodies etc. All functions, which the manufacturer assigns to his AR in Ukraine, should be stipulated in the contract.
- Is it necessary to sign a contract if the manufacturer assigns functions of the AR to his representational office or to the distributor?
If the Ukrainian party, according to the acting contract, has not powers of the AR, it is necessary to either issue the power of attorney, or conclude a separate contract or additional agreement to the acting contract.
- What risks are the most typical for manufacturer and AR?
Basic risks, as a matter of fact, are equal both for the manufacturer, and for his AR: Most commonly It is delays or failed procedure of the conformity assessment procedure which may postpone introduction of the medical product into the market, but also to cause penal sanctions on the manufacturer and his AR by the controlling bodies. Therefore the AR should make the choice of the body of assessment of the conformity of medical products to the Technical regulations extremely prudently.
- What about termination of the contract with AR?
Reasons for the termination of the contract should be stipulated in the contract. It should be, as a rule, non-fulfillment or improper fulfillment of the contractual obligations by the parties or the force-majeure circumstances. Usually the termination of the contract with AR shall not oblige the manufacturer to withdraw from the market the products put into the circulation (its lot), change its packing and undergo the procedure of the assessment of the conformity to the Technical regulations once more.
- May one authorized representative render services to several manufacturers of medical products?
Yes, it is possible and not prohibited by Ukrainian law. In this case the AR should, as a rule, notify all manufacturers, whose products he represents in Ukraine.
The answers were provided by IMPROVE MEDICAL – Conformity assessment Body which performs conformity assessment with the Ukrainian technical regulations (regulations #753, 754, 755) for medical devices, active implantable medical devices and in vitro diagnostics.