Registration and certification of medical products

in Russia

What advantages do You get working with us?

A full range of services

All types of consent documents for import/export of medical products

What do You pay for?

Works on registration and certification of medical equipment

What documents do You need to prepare?

Set of documents

Laws

Promotion of medical products in the Russian market

Classification
of medical products

Reference Material

 

...
Registration and Certification in Czech Republic:

To import medical devices to the Czech Republic, a foreign producer should have an importer in the Czech Republic. To sell medical devices in the Czech market, several points are important:
1. Medical devices have to obtain the CE mark (if required). This is mainly the responsibility of manufacturer. By the use of the CE mark the manufacturer proves that the product is in compliant with the requirements of EU Directive 93/42/EEC that sets technical requirements for medical devices. There are a few medical devices that do not need to obtain the CE mark but their number is limited. Typically customized medical devices or medical devices designated for clinical trials.
2. Medical devices have to have Directions for use enclosed in the Czech language.
3. The Declaration of Conformity has to be submitted (in the Czech language). The Declaration of conformity must contain the following information: product identification; the EU directives with which the product complies; standards used to verify compliance with the directives; name of the Notified Body used (if its use is required by applicable directives); signature on behalf of the manufacturer or the authorized representative; and the manufacturer's name and address. Declaration of Conformity applies to all EU countries.
4. The Czech importer has a notification duty at Ministry of Health (forms are available on www.mzcr.cz/kat/67).

The same procedure and rules apply for the importation of new, used and refurbished medical equipment. Eastern Europe has been considered a potential market for use of refurbished equipment. However, there is a lack of awareness amongst customers of the advantages refurbished systems have over used systems in the Czech Republic. Recently, it seems that the Czech Republic prefers top-level new technologies. This can be the case especially in connection with preparation of International Clinical Research Center project in Brno. There are cases of repeated use of single-use medical devices (however, mainly in cases where this is indicated as an option by the manufacturer).
There are no restrictions for public health institutions with regard to purchasing of refurbished medical devices. All health institutions can only purchase medical devices and equipment that are certified by the Czech Ministry of Health for sale in the Czech Republic.

Labeling and Marking Requirements:

Labeling must be in the Czech language. Information must include the name of the product, names of producer and importer, country of origin, and information necessary for the safe use of the medical device. Instructions for use are obligatory except for medical devices of class 1 and 11a unless instructions for use are necessary for safe use of the medical device. In addition, international norms for warning labels apply. Czech importers/distributors are responsible for the correct labeling of products that are put on the Czech market, and can typically advise the U.S. exporter of specific requirements regarding labeling and marking.

Customs Duties:

The Czech Republic is an open, highly developed market with liberal policies and intense competition. While imports from the EU are exempt, products from non-EU countries are subject to import duties. Customs duty rates are updated annually and are harmonized within EU countries. Duty on medical equipment is, in most cases, zero percent. The value-added tax (VAT) applies to all goods, both domestic and foreign, sold within the Czech Republic. The majority of medical equipment falls into the 5 percent VAT category, the remainder has a 19 percent VAT.
The metric system of weights and measures is standard in the Czech Republic. Czech is the official language in the Czech Republic. More than half of the company representatives are able to communicate in English or in German.

 

 


The 1st step to work with us:

Russia (Moscow)
PromExpert Group +7495729-25-14
+7 495 795-52-36
medical@promexgost.com PromExpertGroup

Germany (Monchengladbach)
PromExpert GmbH +49 2161 498-67-33
info@promexgost.com

Ask a question

References of Customers

Registration of medical equipment in other countries