Have you thought about who is responsible for the quality and safety of imported goods? In Ukraine, this role belongs to the Authorized Representative. This is a legal entity or an individual entrepreneur who has residency.

The presence of an authorized representative for any non-resident manufacturer is a requirement of Ukrainian legislation. Therefore, one of the first steps in the process of certification of medical products or cosmetics is the appointment of the authorized representative of the manufacturer in Ukraine. The authorized representative acts as an official intermediary between the producer and the Ukrainian market, including with state institutions responsible for market surveillance.

An Authorized Representative has certain duties. These duties are defined by the Technical Regulations and legislative acts:

Usually, foreign manufacturers choose an authorized representative according to their own requirements and preferences. This can be an existing distributor or an independent company such as Miasphera. 

Let’s consider both cases in more detail.

Situation 1: The authorized representative is a dealer-importer

If the authorized representative is a dealer-importer, the manufacturer is more dependent on its conditions. In this case, the representative-dealer often acts in his own interests, closing the supply and sales to himself and limiting the rights of the dealership to other companies. In addition, he has an additional competitive advantage – his name, as an Authorized Representative, is present on the labeling or on the instructions of all products.

Situation 2: The authorized representative is a dealer-importer

If the Authorized Representative is a company that is not involved in the sale of products, the manufacturer can independently choose any number of dealers with whom he wants to cooperate.

Important clarification! Each type of medical device must be associated with only one Authorized Representative.

As you can see, the last option has more advantages for the manufacturer, as it allows you to regulate the number of dealers and grant the right to import and distribute your products to other companies.

Miasphera offers independent outsourcing services of the Authorized Representation, because we have many years of experience.

We work with a wide range of medical, cosmetic, food and veterinary products and always keep our finger on the pulse of legislative innovations.

Contact us and take an important step towards a successful start on the Ukrainian market!

On March 12–14 in Kyiv, the Pro Beauty Expo 2024 was held. These unforgettable three days of the exhibition have passed very quickly.
Miasphera was pleasantly surprised by the coordinated organization and incredibly stylish stands of the participating companies, which left a pleasant aftertaste of aesthetic satisfaction.

Our team received a dose of spring inspiration, a charge of energy and, of course, many new pleasant acquaintances and contacts in the cosmetology industry.

And so, after catching our breath, incredibly inspired, we start planning visits to the next events in the field of beauty.

See you at the next events. Let’s see how it was 🙂

The use of cannabis in the world for any purpose has always been the subject of intense attention among medical professionals and public opinion. And our country is no exception! The stages of legalization of medical cannabis in Ukraine are still going through a thorny path of legislative vicissitudes and changes.

But in the last year, the issue of the legal status of cannabis and its legalization in Ukraine has made significant progress.

An important event took place on February 13, 2023. The President of Ukraine signed Law №7457 on regulating the circulation of medical cannabis. The law will enter into force six months after its promulgation.

Stages of legalization of medical cannabis in Ukraine

Stages of legalization of medical cannabis in Ukraine

The main goal of the law is to increase access to medical cannabis preparations for the treatment of a number of diseases. According to the Ministry of Health, more than 2 million Ukrainians currently need cannabis-based drugs. The adopted law declares that the circulation of varieties of plants of the genus hemp (Cannabis) for medical purposes, products of their processing and medicines produced from them, is allowed only for the purpose of their use in medical, scientific and scientific and technical practice.

Distribution and consumption of cannabis for recreational purposes among the public will be prohibited. Therefore, a potentially important new tool can be considered the introduction of a traceability system for the circulation of varieties of hemp plants.

The issue of cannabis legalization in Ukraine opens up a wide space for discussion of new business prospects. This can be a significant stimulus for the development of new sectors of the economy, not only in the field of the production of medical and cosmetic preparations based on Cannabis plants, but also the industrial cultivation and processing of hemp. Further scientific research into the properties of existing varieties of hemp and their subspecies is also of interest.

In one case or another, the adoption of the law does not mean that cannabis plants and drugs based on them will be widely available to Ukraine already this year. We can safely predict that some time after the adoption of the law, the electronic registers defined by the draft law will be formed, algorithms for controlling the circulation of plants, conditions for granting quotas, etc. will be prescribed.

lawyer miasphera

Vitaliy Kovbasa, a leading lawyer at the Miasphera consulting company, talks about the prospects and conditions for the legalization of cannabis-related activities in Ukraine.

“Rejecting skepticism and assessing the situation objectively, we can state this process will not be clearly defined in the nearest time. Those who wish to pursue cannabis-related activities in the future need to worry about the legal side now. The most important thing before starting such activities is to ensure the availability of appropriate licenses and pass the appropriate certification procedures,” Vitaliy comments.

What should be taken into account?

Licensing, namely obtaining a license for:

Certification, namely:

Therefore, all types of activities related to the circulation of hemp plants are allowed only if the subjects of such activities have the appropriate licenses and undergo the appropriate certification procedures.

Disclaimer: This article doesn’t promote the use of drugs or any other illegal substances. The text is a description of the history and scientific studies of the influence of cannabis on society, man, and his physical and mental health.

Dear customers and partners!

We have important news for you. Miasphera has joined the Association of Medical Devices Market Operators (AMOMD).

The Association of Medical Devices Market Operators is a Ukrainian professional association that includes about 80 national manufacturers, importers, distributors of medical devices, cosmetic products, personal protective equipment, and disinfectants.

The main mission of the association is to promote the development and legal protection of the interests of all participants in this market. Such consolidation makes it possible to maintain healthy competition in the industry, influence legislative regulation and protect the professional interests of participants before the state.

Currently, Miasphera actively promotes its services specifically for national manufacturers of medical products. Therefore, cooperation within the Association is an important step towards dialogue and the establishment of new partnership relations.

The mission of Miasphera is to help businesses develop within the limits of legislative norms on the territory of Ukraine, thus making a significant contribution to the development of the country’s medical industry.

Miasphera team

The first mentions of the cultivation of cannabis by mankind date back to 4000 BC. This plant has been used for thousands of years as a medicine, as a source of food, fiber, oil and paper.

The history of mankind’s interrelations with cannabis has always been influenced by various cultural, social and local trends. Cannabis was used to treat various diseases in ancient China and India. Cannabis was used in the treatment of constipation, malaria, rheumatic pains and women’s ailments. The one spread to Africa and Arab countries in the Middle Ages, where it was used mostly in medicine, as well as in cultural and religious rituals. Marijuana was first used as a pain reliever in Ancient Greece. Cannabis spread to Europe and America in the 15th century, where its use became especially popular among doctors and artists.

Cannabis in the 20th century: from medical uses to prohibitions

At the beginning of the 20th century, there was a rapid growth in the consumption of cannabis, including due to its recreational properties. At the same time, despite its great popularity, cannabis began to be banned en masse. It all started with the international opium convention signed in 1912. Initial control of the circulation of hard drugs and cannabis was introduced between the participating countries: Germany, Prussia, the Russian Empire, Great Britain, the Netherlands and many others. Marijuana was allowed to be produced and used only for medical purposes.

During the 1930s, an anti-marijuana campaign arose in the United States. The cannabis tax law was introduced in 1937.

At the same time, the popularity of hemp continued to grow in industry, for example for the production of ropes, shoes and clothing. In 1942, Henry Ford creates an experimental body made of hemp, which turned out to be 10 times stronger than steel of the same thickness. Hemp biodiesel was supposed to be the fuel for the car.

In the 1960s and 1970s, marijuana became especially popular among the counterculture youth, who became its main consumers. It becomes a kind of symbol of the hippie movement, as well as musical and artistic self-expression.

During this period, cannabis becomes the object of prohibition in many countries due to the danger of abuse and its psychotropic properties. The world history of marijuana takes a new turn in March 1961. The UN adopted the Single Convention on Narcotic Drugs. According to the cannabis convention, cannabis resin, cannabis extracts and tinctures were included in the list of narcotic drugs. The signatory countries were obliged to strengthen control over the cultivation of the plant, and to completely stop its use for purposes other than medical and scientific. Cultivation of industrial varieties of cannabis did not fall under the ban.

Legal evolution of cannabis legalization

way of cannabis legalization

Many countries began the process of legalizing cannabis for medical and recreational purposes already at the end of the 20th century. It was an example of breaking traditional stereotypes.

Legal access to herbal cannabis and its use for medical purposes under the supervision of a doctor was first allowed in the state of California (USA) in 1996. In 2001, Canada became the second country in the world to legalize the use of cannabis for medical purposes. Since October 17, 2018, the use of cannabis for medical purposes has been allowed.

On December 10, 2013, the Uruguayan Senate passed a law on the complete decriminalization of the cultivation, sale, purchase and use of marijuana. Uruguay became the first country in the world to fully legalize cannabis.

In December 2020, the UN Commission on Narcotic Drugs removed medical cannabis and all its derivatives from the list of critically dangerous drugs, but about 25 countries still voted against this initiative.

Currently, the world market of cannabis, including for medical purposes, is in the process of rapid development. However, this development is not uniform due to different legal environments and mixed public attitudes.

In contrast to the legalization of recreational use of cannabis, more and more countries allow its medical use every year. In the last 5 years, about 20 countries in Europe (Greece, Estonia, Ireland, Luxembourg, Malta, Macedonia, Germany, Norway, Poland, Portugal, Croatia), North and South America (Argentina, Colombia, Mexico, Peru, Chile) and other countries (Australia, Philippines, Jamaica) have legalized cannabis and cannabinoids for medical purposes.

Legalization of cannabis in the world

Some countries, such as Canada and the US, have adopted fully regulated frameworks that allow the cultivation, consumption and retail distribution of various cannabis-based products. So in South Africa, it is legally allowed to grow hemp, but not legalized retail sales.

In general, despite the slow changes, the world is witnessing the liberalization of the legal framework of international documents regarding the circulation of cannabis compounds and cannabinoids for medical purposes and the decriminalization of their use. Such drugs and preparations are gradually becoming available to patients in different countries.

Medical devices are classified depending on the design, features of application and potential danger in case of their incorrect use. Therefore, before starting the certification process, the manufacturer of the medical device must determine its medical purpose and intended use.

Each country has its own requirements. Currently, the medical device classifier NC 024:2023 operates in Ukraine. It is created on the basis of the GMDN international nomenclature.

The safety class of a medical product depends on the potential risk during its use by the consumer. Medical products are classified according to the following criteria: invasiveness, duration of use, presence of contact with the human body, effect on vital human organs, as well as the possibility of using energy sources together with the product.

Criteria for the classification of medical devices

Criteria for the classification of medical devices

So, according to the degree of safety, medical products are divided into:

Class I — a low proportion of risk
Class IIa — the average proportion of risk
Class IIb — increased risk
Class III — high proportion of risk

According to the duration of use, medical products are:

Temporary – for continuous use up to 60 minutes;
Short-term – for continuous use up to 30 days;
Long-term – for continuous use for a period of 30 days or more.

According to invasiveness, medical products are:

Non-invasive are medical devices or means that do not require invasion or penetration into the human body for diagnosis, monitoring or treatment.
Invasive are medical products that are completely or partially introduced into the human body through its surface or body opening.

Why is this classification important?

Accepted safety classes of medical devices reflect the potential risk in case of their use by consumers. Therefore, depending on the defined class and characteristics, the medical device certification procedure may differ. After all, the higher the risk class, the more complicated the registration procedure is.

How should the manufacturer act?

In the further sale of products, mistakes in determining the class can be expensive. Therefore, if you have doubts about the correct classification of your own product, contact Miasphera specialists!

We will be happy to provide comprehensive advice and suggest the best certification options for your product.

Leave an application for consultation.

Registration of cosmetics in Ukraine is one of the popular queries in search engines. This is not surprising, because the trend of the last decade is the growth of the cosmetic market. This is indicated by a stable increase in the volume of production and sale of cosmetic products. Cosmetics have long become not just a product for care, but also a necessary element of a person’s daily use.

The Ukrainian market of cosmetic products is no exception. Therefore, the issue of the appearance of new products, increasing the number of manufacturers and technical regulation of the circulation of cosmetics is an urgent issue for Ukrainian legislation.

How to legally register cosmetic products in Ukraine?

Is the certification of cosmetics mandatory, and when does the new Technical Regulation come into effect? Vitaliy Kovbasa, the chief lawyer of MIASPHERA company, answers these and other questions.

We will provide some theory and understanding of the term “cosmetic products” from the Ukrainian legislation.

Cosmetic products in Ukraine are regulated in accordance with the Law On Cosmetic Products dated 04/05/2012 No. 4616-VI.

Requirements for cosmetic products on the market of Ukraine

Any substance or mixture of substances can be considered a cosmetic product. They are intended for use on the external parts of the human body in order to clean, aromatize, restore, protect and correct the smell.

Every foreign manufacturer or importer that brings cosmetic products to the market of Ukraine undergoes a simplified procedure for declaring compliance. Cosmetics from the EU already meet the standards that will soon be implemented in our country. It is enough for the importer to provide a certificate from the manufacturer and a safety data sheet for the products.

The national producer has to do this procedure by obtaining a conclusion from a sanitary-epidemiological examination of production and products.

How is the registration of cosmetics in Ukraine now?

Registration of cosmetic products in Ukraine for a national manufacturer is carried out through the voluntary receipt of a sanitary-hygienic expert opinion, which confirms the safety of products for human health and gives the right to sell them. This procedure is valid until the Technical Regulation is fully implemented.

The process of regulation of cosmetic products in Ukraine is actively integrated with the legislation of the European Union. On the basis of EU Regulation No. 1223/2009, a technical regulation for cosmetic products was developed for Ukraine. This normative act was postponed several times, but was still adopted by the Cabinet of Ministers on January 20, 2021.

In connection with the hostilities, the Ministry of Health proposed postponing the entry into force of the Technical Regulation until August 3, 2024, and introduced a transition period for participants in the cosmetic products market until August 3, 2026.

Evolution of regulatory requirements for cosmetics in Ukraine

Evolution of regulatory requirements for cosmetics in Ukraine

The main purpose of introducing the Technical Regulation is to establish new standards for cosmetic products on the market of Ukraine, to define the rights and obligations of market participants regarding the introduction of cosmetic products into circulation, as well as to remove administrative barriers in trade with the countries of the European Union.

The process of registration of cosmetic products will become radically new after the entry into force of the technical regulation.

Changes in the cosmetics registration procedure in accordance with the Technical Regulations

Changes in the cosmetics registration procedure in accordance with the Technical Regulations

It should be noted that there is a transition period until the entry into force of the Technical Regulation. This gives market operators time to prepare. The sale of cosmetics manufactured before 08/03/2026 will not be prohibited or restricted for the next 5 years.

How is Miasphera useful for a cosmetics manufacturer?

If you are a manufacturer of cosmetics and are planning further development of your own production, you should approach this issue strategically now. The transition period in legislation is always a time of additional actions and new steps. In order not to waste time and avoid a number of unfortunate mistakes when registering cosmetic products under the new rules – contact MIASPHERA! We will provide full legal support and support at all stages of bringing cosmetic products to the market of Ukraine! MIASPHERA specialists will gladly share their successful experience!

What Miasphera can do for a cosmetics manufacturer:

  1. Analyze the current state of affairs and draw up a roadmap for further actions. We will suggest options for further development of your business, based on the assessment of possible risks and benefits
  2. Conduct an audit of current production, help with the development of technical specifications for products, standardization of production conditions, obtaining SES certificates;
  3. Provide outsourcing services of an authorized representative;
  4. Check for conformity of labeling, current instructions and promotional materials;
  5. Create a product dossier and carry out the notification procedure;
  6. With the help of our partners, we will develop and implement GMP standards.

We are always one step ahead and work according to new standards!

Would you like to receive a consultation? Leave an application using the link.

If you are a manufacturer or exporter of cosmetic products and have a desire to conquer the market of the European Union countries, you must do the registration procedure for your cosmetic products.

The procedure goes through the assessment of the conformity of cosmetic products in accordance with EU regulations and directives. If say briefly: your product must meet EU standards for this type of product.

Requirements for cosmetic products on the EU market are regulated by Regulation №1223/2009.

The regulation prohibits cosmetic products whose ingredients or final composition have been tested on animals from entering the EU market. Carcinogenic, mutagenic or toxic substances for reproductive health are also prohibited for use.

Conformity assessment consists of two main procedures: drawing up a Product Safety Report (CPSR) and notification. It sounds scary, but in this article we will explain this confusing issue.

Cosmetic products include a wide range of products. Direct contact with the human body is one common feature. It is this feature that is the reason for careful study of the physicochemical parameters of any cosmetic product.

A Safety Report (CPSR) allows you to make sure that the product under investigation is safe for use. It contains important data on the results of research on the composition and individual components. The procedure includes the creation of an information file, where each tool is marked with the appropriate marking and conditions of production compliance with EU legislation.

Notification is the process of entering cosmetic products into the pan-European database (CPNP). This process based on the basis of a product safety report.

So, we’re having dealt with the definition of the main terms! Now we can form the stages on the way to a successful procedure for evaluating the conformity of cosmetic products:

Successful completion of the first stage allows you to create a road map of the entire process of product registration and the final list of necessary documents for the creation of a dossier – PIF file.

In the case of registration of cosmetic products on the territory of the European Union countries, it is necessary to take care of the presence of an authorized representative.

This responsible person must register on the territory of the EU country, has full information about the products, is legally responsible for compliance with the requirements of cosmetics regulations and, if necessary, provides all necessary information at the request of supervisory authorities for control and monitoring of activities.

According to the Cosmetic Regulation (EU) №1223/2009, the authorized representative is legally responsible for a cosmetic product of a non-European manufacturer on the EU market.

All cosmetic products entering the EU market must have the following package of documents:

The Safety Data Sheet (MSDS) of cosmetic products is developed based on the data of the manufacturer and the authorized person. It contains more detailed information about: composition, possible risks of harm to humans, rules of conduct in case of improper use, storage and disposal conditions. This document is important not only for export operations, but also for the end user to ensure the correct and safe use of the product.

Registration may be refused if the cosmetics do not comply with the established safety standards of a certain country or if an incomplete package of documents is submitted.

The large number of restrictions on the production and use of cannabis in different countries often lead to misunderstandings and confusion in the concepts themselves. Not everyone realizes why there are three different names – cannabis, marijuana and hemp and what exactly is the difference between them. And those who do not know about the existence of industrial varieties are hostile to all cannabis in general.

So, cannabis, hemp or marijuana – which is correctly?

Answer: all names are correct! But from the point of view of botany, medicine and law are completely different things. There are different subspecies and products made from the same hemp. Let’s figure out what hemp is and why there’s been so much talk about it.

The plant of the genus Cannabis or Hemp is an agricultural crop characterized by jagged leaves and a characteristic smell. Botanists divide these plants by structure and classify them based on morphology, physiology, and origin. The most famous subspecies are Sativa and Indica or their hybrids.

Sativa is a tall plant with thin leaves that is traditionally grown in Latin America, North Africa, and Southeast Asia. The subspecies has an elevated level of tetrahydrocannabinol (THC).

Indica is a low-growing subspecies with a high level of cannabidiol (CBD) and is grown mainly in the mountainous regions of India and Pakistan. 

There is also a wild subspecies – Ruderalis. It is less common, but on its basis all cultivated varieties of technical hemp with almost zero content of tetrahydrocannabinol (THC) were bred. It is known for its feature of autoflowering, depending on age, not light cycles. Due to its low THC content, it is not used for recreational or medical purposes. 

the many uses of cannabis

In general, cannabis is the Latin name of the plant, which also refers to medical hemp varieties and hemp-based products for therapeutic purposes. Traditionally, medical cannabis has a balanced CBD content and low THC levels.

Marijuana is a smoking mixture of dried female flowers of sativa and indica. Marijuana has a higher percentage of psychoactive substances (THC more than 0.3%) compared to hemp and has psychotropic properties (a mild drug).

Why are there three names?

In connection with the legalization of medical cannabis, it became necessary to name different subspecies of hemp and products based on them. Thus, manufacturers distanced those who needed to use these plants specifically for medicinal purposes from users for recreational consumption.

How to determine the legal status of the cannabis plant?

These names should be clearly distinguished. So, knowing the properties, we can summarize that:

Hemp is an agricultural crop that includes all varieties of Cannabis Ruderalis. Hemp is a source of ecological textiles and paper, widely used for industrial purposes.

Cannabis is the designation of specialized varieties bred for therapeutic purposes, regardless of their narcotic properties.

Marijuana is a smoking mixture of dried female flowers of sativa and indica, which has the properties of a light narcotic.

Medical Marijuana or Medical Cannabis – This term is used specifically for the Sativa derivatives of cannabis that are used to relieve the symptoms caused by certain diseases.

What is the difference between medical and recreational marijuana?

The main difference is in the THC content. It is incorrect to equate medical marijuana with recreational marijuana, since its purpose is not to bring pleasure, but to relieve pain symptoms. And therefore, medical cannabis is specially bred varieties with a changed THC content.

Currently, many varieties of cannabis Sativa plants have been bred specifically for medical use.

The main active substance is cannabidiol (CBD). The results of scientific research show that herbal preparations with CBD effectively block various types of pain, increase appetite, help overcome depressive states, and prevent epileptic attacks. This is an important remedy for people suffering from constant pain, oncology and AIDS.

Medical cannabis has shown potential in alleviating symptoms associated with neurological diseases such as epilepsy, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, and neuropathic pain. But it is important to understand that cannabis is not a panacea and such treatment may not be useful for everyone.

Currently, numerous studies are being conducted around the world on the effect of medical cannabis in the treatment of particularly complex diseases.

But at the same time, the ambiguous legal status of different chemotypes makes it difficult to study the properties of cannabis. A mandatory condition for conducting research is a special license, obtaining which is a rather bureaucratic procedure.

We hope that science will stubbornly move forward in this matter, discovering new useful ways of using hemp and its derivatives in medicine, chemical industry, industry and agriculture.

WARNING! The article is posted for educational purposes and does not promote the use of drugs. We hope our publication brought a scientific understanding of the topic and helped to understand the differences in terms.

Today, every global medical device manufacturer is undoubtedly facing a difficult question: “Should I import medical devices to Ukraine?” And the answer is very simple: “Yes, of course”.

For many global medical device manufacturers that were present on the Ukrainian market before the war, the current permits for medical devices are now a stellar time, a time when Ukraine is gradually rebuilding and restoring its damaged medical infrastructure.

To support the positive answer to the above question regarding the import of medical devices to Ukraine, we provide statistical data:

The state budget of Ukraine for 2022 allocates UAH 195.9 billion for healthcare, and with additional funding due to the full-scale war – UAH 232.8 billion. In 2023, the budget allocates UAH 175 billion for healthcare, including UAH 10.3 billion for centralized procurement of medical products in 31 areas in 2023.

Import of medical devices to Ukraine

However, Ukraine is on a course to standardize with Europe, and while restoring and rebuilding the lost medical infrastructure, it aims to introduce the latest technologies and products, including medical devices.

Therefore, it is time for global manufacturers with the latest and most advanced medical technologies and products to discover the Ukrainian market and start importing medical devices to Ukraine.
An Authorized Representative appointed in Ukraine will help a global manufacturer of medical devices to overcome all the difficulties related to the import of medical devices to Ukraine. Since any import of medical devices to Ukraine for manufacturers of medical devices that are not residents of Ukraine is not possible without the appointment of an Authorized Representative in Ukraine.
It is the Authorized Representative, who may be a trade participant or solely the holder of registration documents for a medical device, who takes all the necessary actions to ensure that the import of medical devices to Ukraine is successful.

Importation requires a number of mandatory actions and additional actions at the choice of the medical device manufacturer. It is mandatory to conclude an agreement with a company from Ukraine on the provision of services of an Authorized Representative.

Having confirmation of his/her authority, the Authorized Representative examines the technical documentation for the medical device in order to establish the necessary procedure for assessing the conformity of the medical device and subsequently initiates its implementation. In other words, import of medical devices to Ukraine that are class I medical devices, non-sterile, without measurement function and medical devices for in vitro diagnostics, and not intended for self-monitoring is possible upon registration of the manufacturer and the Authorized Representative in the Register of the State Service of Ukraine on Medicines and Drugs Control. Instead, medical devices of a higher risk class are subject to the manufacturer’s audit procedure with the involvement of the designated medical device conformity assessment body.

Having such documents as a declaration of conformity of medical devices and/or a certificate of conformity assessment for a medical device, the most difficult stages before importation are completed.
Ukrainian legislation allows importing medical devices into Ukraine subject to confirmation of their compliance with the Technical Regulations (as evidenced by the aforementioned declaration and/or certificate), the label for the medical device developed in Ukrainian, and the instruction for use of the medical device.

Due to the fact that in Ukraine, as in other countries, the circulation of medical devices is regulated, a number of requirements are set for the said labels and instructions for use of the medical device in terms of their form and content. This complex task is undertaken by the Authorized Representative, and the medical device manufacturer will only need to provide technical files for the medical device, which will be processed by the Authorized Representative to develop the correct label and instruction for the medical device.

The above-mentioned documents are subject to inspection at the customs during the regulated procedures for customs clearance of medical devices in Ukraine, which are determined depending on the medical device, according to the UKTZED code for the product.

From this stage, the manufacturer of medical devices can carry out the production of such devices in order to import medical devices to Ukraine. And the benefit of the Authorized Representative at the following stages is no less important, since the Authorized Representative can search for a logistics partner for the import of goods, advise a reliable dealer, and take actions aimed at preventing gray imports of medical devices by the manufacturer in the Ukrainian market. The above actions are additional for the medical device manufacturer, but no less important for the successful import and sale of medical devices in the Ukrainian market.

Importing medical devices to Ukraine is simple, not expensive and predictably successful if you entrust this business to a reliable partner – an Authorized Representative.
Import medical devices to Ukraine – join the rebuilding and restoration of Ukraine, for peace, justice and democratic values.

Просп. Соборності, 30-A, 318
Київ, 02154, Україна
Відділ продажів
+380 44 498 88 58
+380 68 498 88 58
Зроблено з