AUTHORIZED REPRESENTATIVE OF MEDICAL PRODUCTS MANUFACTURER: RESPONSIBILITIES AND POWERS

Upon entering into the new regulation of medical devices, circulation in the Ukrainian market of foreign manufacturers for these products, came up against a situation where a series of procedural issues arose. One of them is the issue of Authorized representatives, their powers and responsibilities. Our specialists collected the most accurate questions concerning this topic, and gave them full and complete answers.

Who can be an Authorized representative?

Pursuant cl. 2.13 of the Technical Regulations the Authorized representative is a legal person or a physical person – an entrepreneur who is a resident of Ukraine or is registered in accordance with the legislation of Ukraine; representative office of a foreign entity that has received due authorities from a manufacturer to execute legal actions on its behalf (concerning manufacturer’s responsibilities specified by the Technical Regulations). That is:

  • Legal person – resident of Ukraine;
  • Physical person – entrepreneur – citizen of Ukraine;
  • Representative office of a foreign manufacturer of medical devices in Ukraine;
  • Distributor of a foreign manufacturer of medical devices in Ukraine.

Who cannot be an Authorized representative?

All other categories, in particular, physical persons and nonresidents of Ukraine.

What document serves as a basis for the Authorized representative to undertake commitments?

The Authorized representative shall be appointed on the basis of a Contract or Power of Attorney. The two parties under mutual agreement choose the kind of the document (Contract, Power of Attorney) that entrusts the Authorized representative with respective authorities.

What shall be specified in the Contract/Power of Attorney and what is the effective duration of this document?

  • It is needed to indicate both, in the Contract or Power of Attorney, the date of its conclusion/drawing, party’s details, list of obligations and the Authorized representative. As a rule, they are as follows:
  • initiate assessment of compliance with Technical Regulations and Quality Management System on manufacturer’s behalf;
  • pay for activities related to assessment of compliance;
  • organize translation of manufacturer’s technical documentation;
  • complete a package of documents needed to carry out the assessment of compliance and/or certification pursuant to the requirements of the competent authority;
  • receive Certificates of compliance assessment from certification authorities;
  • maintain manufacturer’s technical documentation, Declarations of compliance with Technical Regulations and/or Quality Management System;
  • notify the manufacturer of unfavorable events/bad effects revealed as a consequence of use of its products;
  • inform potential consumers about technical and consumer-oriented characteristics of manufacturer’s products;
  • inform the manufacturer about any change in normative documents, etc.
  • In addition, as a rule, the Authorized representative’s right to transfer his/her powers given by the manufacturer to third persons is also stipulated by the Power of Attorney or Contract (for example, the Authorized representative may entrust a specialized translation agency to translate documentation), however, the Authorized representative bears responsibility for actions of third persons as if they were his/her own actions.

The parties autonomously fix the duration of the Contract/Power of Attorney; however, it shall not be less than 5 years.

What are the functions exercised by an Authorized representative? What is his/her responsibility?

The main function of the Authorized representative consists in representation of foreign manufacturer’s interests on the territory of Ukraine and maintenance of communication between the foreign manufacturer of medical devices and the Ukrainian market. In this context the “Ukrainian market” means not only the sales market itself, but, first and foremost, the authorities for compliance assessment, supervisory authorities, fiscal authorities, etc.

All functions entrusted by the manufacturer to his Authorized representative in Ukraine, shall be specified in the Contract or Power of Attorney.

The scope of responsibility of the Authorized representative is specified in the Contract or Power of Attorney. It usually covers the issues of submission, transfer and maintenance of information and documentation.

For example, a standard contract with an Authorized representative on the territory of the EU provides for the following functions for the Authorized representative:

  • Issuance of the Declaration of compliance;
  • Execution of activities to confirm the compliance, including the organization of trials and tests and presentation of a package of documents to competent authorities which is needed to carry out the respective procedures. Supervision of passing the procedures of compliance assessment.
  • Execution of activities needed to elaborate and maintain technical documentation – product technical file.
  • Maintenance of manufacturer’s technical documentation, Declaration of compliance, Certificates of compliance assessment.
  • Execution of functions of manufacturer’s contact person for issues concerning the compliance of products with the effective norms and standards in the course of supervisory actions and activities of regulatory bodies.
  • Execution of functions of manufacturer’s contact person for consumer incidents, including participation in consumer expertise, tests, etc. The Authorized representative undertakes not only to inform the manufacture of such events, but also take part in their analysis.
  • Information of the manufacturer about any change in Standards, Technical Regulations, related to manufacturer’s products.

If a manufacturer entrusts functions of the Authorized representative to its Representative office or a distributor, is it needed to conclude a Contract or issue a Power of Attorney?

If the Ukrainian party is not invested with authorities of the Authorized person within the terms and conditions of the effective Contract, it is needed to issue a Power of Attorney or conclude an additional agreement to the Contract, or sign a special Contract.

What are the most common risks for both parties in such contracts?

The main risk, in principle, is the same for both the manufacturer and its Authorized representative. It is a failed procedure of assessment of compliance of medical devices with the Technical Regulations – in the course of its execution, various subtle aspects and delays may arise that may postpone the market launch of the medical product for an indefinite period and even cause imposition of penalties on the manufacturer and its Authorized representative by regulatory bodies. For this reason, Authorized representatives must be extremely diligent in choosing the competent body to carry out the assessment of medical devices compliance with the Technical regulations.

What may be reasons to cancel the Contract/ revoke the Power of Attorney?

Reasons to cancel the Contract shall be specified in the Contract itself. As a rule, it is non-fulfillment or undue fulfillment of undertaken commitments by the parties or force-majeure circumstances.

If the Contract between the manufacturer – non-resident and the Authorized representative is cancelled, is it necessary to pass the procedure of compliance assessment all over again and change the packing?

As a rule, the contract between the manufacturer and its Authorized representative specifies the transition period for the former Authorized representative to continue execution of a part of his/her obligations. In addition, the change of the Authorized representative does not bind the manufacturer to revocation of products (or their batch) put into circulation from the market, change its packing and pass the procedure of assessment of compliance with Technical Regulations all over again.

May one Authorized representative render services to several manufacturers of medical products?

Yes, he/she may do it – if it is one and the same kind of products.

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to get answers to questions concerning the assessment of compliance of medical devices with the Technical Regulations.

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Complete this form and we will contact you in one working day

If you need to speak to someone right away, you can call us at +380 44 3531835

Fields marked by asterisk (*) are required