Certification of goods
Declaration and certification, depending on the product. This stage is mandatory, regulated by law, a requirement of the state. As part of this service, we offer the service of an authorised representative. The cost and terms of certification vary depending on the number of items, the item itself and the requirements of the regulations and the documents provided. Information is provided after the documents are examined.
CONSULTATION
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Certification process
01
Specify the type and quantity of goods to be certified
02
Conclusion of a service agreement. A specification is drawn up for each service
03
Providing a list of documents to be analysed. Examination of documents
04
Selecting the optimal method for the certification procedure from the two available
05
Appointment of an authorised representative of the manufacturer in Ukraine
06
Obtaining a certificate, declaration and entry into the register of the State Service of Ukraine
Authorised representative
Required for work in Ukraine
An authorised representative is a requirement of Ukrainian legislation and a prerequisite for placing products on the market. An authorised representative is a legal representative of the manufacturer who, on its behalf
- communicates with government agencies;
- is responsible for the product on the Ukrainian market and, at the direction of the manufacturer, grants the authority to import and distribute the product in Ukraine to the customs authorities;
- annually conducts the procedure for confirming the validity of certificates for goods and provides the manufacturer with confirmation of the certificate's validity;
- accepts complaints and resolves disputes, if any.
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We advise the manufacturer to choose an independent authorised representative who does not sell the manufacturer's goods and is not a market participant (seller). This gives the manufacturer the freedom and flexibility to choose any dealer to cooperate with and not be limited to working with the only seller on the market.
List of medical devices
Certification and declaration
List of medical devices in Ukraine that are subject to certification and declaration: Classifier of medical devices NK 024:2019, (hereinafter referred to as NK 024:2019) Declaration: Class I medical devices, in-vitro diagnostic devices, group "other".

Certification:
1. Medical devices for in-vitro diagnostics intended for self-monitoring;
2. Non-sterile medical devices of classes Im, IIa, IIb, III, as well as in-vitro diagnostic devices from List B and devices intended for self-monitoring;
3. Sterile medical devices of any class, in-vitro diagnostic devices from List A, active implantable medical devices.
launching product in to the Ukrainian, European, and American market
Сфера Miasphera
Our expertise is confirmed by
GondDond Medical a giant in the manufacture of medical consumables for analysis (vacuum tubes, needles, tips, syringes, containers for biomaterial collection).
With more than 30 series, 800 categories and 90,000 products with specifications, WEGO has become one of the most trusted providers of medical system solutions in the world. At the same time, WEGO is actively involved in the healthcare sector and provides renal dialvsis services.
Асоціація операторів медичного ринку
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.
reyestratsiya-dytyachykh-tovariv-fanny-time
Funny Time is a Ukrainian brand that develops and produces educational games for children. It creates a space for children to play independently and spend family leisure time as opposed to gadgets that make children dependent and psychologically limited.
The Eximlab company has been known in Ukraine for 15 years as a manufacturer and supplier of laboratory glassware and control and measuring instruments. The company has its own production of blood sampling equipment, and our products are widely used in medical laboratories, clinics and hospitals.
FOYOMED has a wide range of products, including leading respiratory products, disposable medical devices, medical equipment and laboratory products. FOYOMED products are exported to more than 100 countries through a network of distributors and subsidiaries covering North America, South America, Europe, Asia and Africa.
MIASPHERA
30-A, Sobornosti avenu, office 318,
Kyiv, 02154, Ukraine
mia@miasphera.com
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