Commissioning of medical devices needed to counteract COVID-19
The manufacture, sale and use / operation of most medical products in Ukraine is traditionally very regulated. This is not surprising, since one of the main priorities of state bodies is to ensure the safety of life and health of citizens from the potentially harmful effects of low-quality products.
However, in response to the global coronavirus pandemic, the Government proposed a temporary procedure for the introduction of certain medical devices that could potentially counteract the disease.
Therefore, we are quite often asked to explain this procedure, as well as the situation that may develop after the end of quarantine. This publication will cover the new procedure as compared to its standard version.
Today, we will elaborate on how the entire procedure was simplified and what it takes now to register certain categories of medical devices.
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What does the “standard registration procedure” mean and what are the general rules adopted before quarantine?
The modern procedure for introducing medical devices into circulation was introduced on July 1, 2015. This was the date when the system of “state registration” was converted into the system of conformity assessment of products with technical regulations. The new procedure is, in fact, a continuation of EU legislation, and is practically similar to it.
In general, the conformity assessment procedure provides for a specialized expertise to be conducted by an accredited authority of all norms provided for in the technical regulations (both in respect of the product itself and its development and manufacture). As of today, there are 3 Technical Regulations on:
- Medical devices;
- Implantable medical devices;
- In vitro diagnostic medical devices.
The conformity assessment procedures can be divided into two groups:
- The procedures performed by the manufacture itself (the so-called self-declaration procedure). This procedure concerns medical devices of the lowest risk group and provides that the manufacturer or the importer can perform all the control actions and handle formalities stipulated by the regulation on its own. As a result, the person issues a certificate of conformity and informs the State Service of Ukraine on Medicines and Drugs Control, which allows for full delivery, sale and use of the devices.
It is necessary to understand that even the self-declaration procedure has its “pitfalls”, namely: it is necessary to understand, whether the products are subject to “self-declaration”, to know all the subtleties of the procedure, marking, to develop the Declaration of conformity and other supporting documents.
- Procedures requiring the involvement of a specialized accredited authority that can assess compliance of the product with the requirements and handle all formalities provided for in the regulations. The manufacture may itself choose this authority.
However, today there is a large number of authorities (accredited) in the market, which may have significantly different prices, terms of examination and competence of personnel. Our company will help not to get confused in such nuances, and to involve the necessary authority to insure successful introduction of your products to the market.
What is the simplified procedure of commercializing medical devices to combat COVID-19?
First, it is important to understand that the procedure of registration and recording was not simplified for all medical devices, but only for those identified by the Government as having the potential to help stop the spread of coronavirus. The list of such products has been approved and they are allowed to be imported under a simplified procedure.
The simplifications concern customs procedures, preferential taxation and introduction into the market in Ukraine. On April 8, 2020, the list of products was significantly expanded, and medical products now make up the larger half of more than 200 products.
These amendments mean that suppliers have now the right to freely import the said goods into the territory of Ukraine, sell and use them on the Ukrainian market even without the procedure of conformity assessment of their technical regulations.
This procedure is alternative. At the same time, manufacturers may conduct the procedure of conformity assessment. To do this, a person must submit an application of any form to the Ministry of Health, which should specify:
- The purpose of the importation;
- Information about the manufacturer and the name of the product;
- The lot number, its volume;
- Instruction manual (purpose, method of action, etc.).
This information can be submitted both in paper form and electronically. As a result of the procedure, the person receives a message about the introduction of the products, which allows to freely sell and use the goods. On the other hand, customers of goods, including public procurement, should not require mandatory confirmation of conformity assessment.
In the original version of the simplified procedure, medical devices manufactured in Ukraine (not imported) were not mentioned, but now the procedure can also be used by domestic manufacturers.
It should be understood that these changes are temporary, aimed at short-term overcoming the shortage of goods. Therefore, in case of long-term plans for the turnover of funds, we recommend to start the conformity assessment procedure as well.
Our specialists can advise both on a certain step or develop a roadmap for conformity assessment, i.e. they can provide you with legal assistance and support of the entire process from start to finish.