Batch certification is one of the main legal procedures. It can be applied for registration of imported medical devices in Ukraine. The certificate of conformity for the batch is issued without experts going to the place of production. In fact, it is issued on the basis of a valid technical file and inspection of the […]
The Lviv Medical Forum 2024 has ended, and we would like to share our results and impressions. The event brought together more than 60 participating companies from Ukraine and Europe. They presented modern medical, dental and rehabilitation equipment, medical and laboratory products, food supplements and latest treatment methods. Miasphera’s team carefully prepared for the event […]
There is traditionally a wide range of dietary supplements on the market of Ukraine. They cover many directions of physiological action and have different forms of release. But sometimes, the information on the package about the properties of dietary supplements can confuse consumers, especially if these products were bought in pharmacies. Therefore, the manufacturer of […]
Understanding the intricacies of medical device certification can seem difficult even for those who have already encountered this topic many times. Therefore, we are sharing useful information and considering the main aspects and issues related to the certification of medical devices on the territory of Ukraine. Let’s go! 1. What is the certification process? Certification […]
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 […]
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 […]
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 […]
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 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 […]
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 […]
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 […]
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 […]
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, […]
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 […]
Certificate of conformity during martial law
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 Lviv Medical Forum 2024 has ended, and we would like to share our results and impressions. The event brought together more than 60 participating companies from Ukraine and Europe. They presented modern medical, dental and rehabilitation equipment, medical and laboratory products, food supplements and latest treatment methods. Miasphera’s team carefully prepared for the event […]
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 […]
Batch certification is one of the main legal procedures. It can be applied for registration of imported medical devices in Ukraine. The certificate of conformity for the batch is issued without experts going to the place of production. In fact, it is issued on the basis of a valid technical file and inspection of the […]
There is traditionally a wide range of dietary supplements on the market of Ukraine. They cover many directions of physiological action and have different forms of release. But sometimes, the information on the package about the properties of dietary supplements can confuse consumers, especially if these products were bought in pharmacies. Therefore, the manufacturer of […]
Understanding the intricacies of medical device certification can seem difficult even for those who have already encountered this topic many times. Therefore, we are sharing useful information and considering the main aspects and issues related to the certification of medical devices on the territory of Ukraine. Let’s go! 1. What is the certification process? Certification […]
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 […]
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 […]
Registration of cosmetics in Ukraine
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: […]
Registration of medical devices in Ukraine, as well as in other countries of the world, implies their legalization and is necessary for the manufacturer to put medical devices on the market. Since 2015, Ukraine has changed the procedure for state registration of medical devices and introduced a procedure for assessing compliance with the requirements of […]
