How to register medical devices?
The declaring of medical equipment is one of the most popular services of our law firm. We decided to analyze the process and basic requirements for the registration of medical devices using the example from our practice.
Previously, this procedure was regulated by the developments of the national legislator. Now all technical regulations concerning medical devices are developed in accordance with the standards of European legislation.
What does it influence?
Most of the documentation required for the registration of medical devices in Ukraine is in English, German, Spanish or other foreign languages. This creates certain difficulties when registering medical equipment. In addition, the legislation of the EU countries has its own peculiarities that may seem unusual for an ordinary Ukrainian businessman.
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Core of the matter: You need to have a reliable counterparty to declare medical equipment
The main criterion to be met in order to register imported medical devices is a reliable counterparty that:
- carries out its activities in accordance with national and international legislation;
- has all necessary technical and other documentation on the medical device to prove its conformity.
That was the case of the Client that has recently contacted our company. The Client had a counterparty but he sought legal assistance with the documentation.
The Client purchased a number of batches of lenses for glasses, which are also belonged to Class 1 medical devices. This was confirmed by the manufacturer’s Declaration of Conformity.
This document usually do not cause any difficulties. However, we are often asked what is the manufacturer’s Declaration of Conformity and where to get it?
- This document confirms that the manufacturer operates and produces its goods in accordance with international or national standards. The declaration varies from country to country and from manufacturer to manufacturer.
However, in any case it must indicate that a product belongs to a certain class and meets all EU quality standards.
- You can get this document from your counterparty that manufactures the product. Usually, if it is a large producer that systematically manufactures medical devices, they themselves provide this document together with the goods.
In our Client’s case, the most difficult document to obtain was a list of all lenses that had to be imported into Ukraine. The problem was that the list of lenses did not coincide with the product catalogue, the technical file and the Client’s wishes, which could cause misunderstandings and possible further negative consequences at the customs and during registration.
Please note! The list of products to be imported must be clear, understandable and contain technical data. This document is called the Annex to the Declaration of Conformity. It is mandatory for drawing up and filing for the registration of medical devices.
Our actions: Execution of documentation required for the declaration of medical devices
Having extensive experience in registering various medical devices, we helped the Client to properly draw up the Annex. The Client provided us with a complete list of lenses and we arranged it correctly in the Annex to the Declaration, taking into account the Client’s needs and possibilities.
In addition, in order to register and import the respective products, we helped the Client to register a legal entity that would act as the recipient of the products and the applicant in Ukraine.
In order to carry out all registration actions and represent the Client’s interests on the territory of Ukraine, we also developed a draft power of attorney.
In addition, it was required to prepare a specific power of attorney for an authorized representative in Ukraine. But we will elaborate on this issue later.
After we have received and analyzed all the necessary input data, we performed the registration procedure, which allowed our Client to successfully import the lenses to Ukraine.
What other problems can arise when declaring medical devices?
Our other Client didn’t know whether the firm-manufacturer has appointed an authorized representative in Ukraine, who can act on his behalf.
Such a representative needs a power of attorney, which must include the following provisions:
- the responsibilities and powers of the representative in Ukraine;
- the procedure for interacting with the Manufacturer, providing consultations and other services;
- processing and ensuring security of information (confidentiality);
- force majeure.
In this case, a provision on the term of the power of attorney plays a special role. In our Client’s case we signed a power of attorney for an unlimited time period. However, not every Manufacturer will agree to this.
Our company’s lawyers know how to correctly draft such power of attorney and can help you with any documentation required for the registration of medical equipment in Ukraine.
So, if you want to easily and reliably register medical devices in Ukraine, don’t hesitate to call us!