Certification | Miasphera | Making the complex simple

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

Certification process

Specify the type and quantity of goods to be certified

Conclusion of a service agreement. A specification is drawn up for each service

Providing a list of documents to be analysed. Examination of documents

Selecting the optimal method for the certification procedure from the two available

Appointment of an authorised representative of the manufacturer in Ukraine

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.

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

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