Medical devices

A foreign company engaged in the production and distribution of medical devices, which has been cooperating with us for a long time, has ordered an internal analysis of its products in relation to the current setting of legislative and regulatory measures.

We conducted a very detailed investigation, including through workshops with the company’s various business units, and designed a concept that included measures that take advantage of business opportunities in response to current market developments and in line with regulatory measures.

The result of this cooperation was to improve the financial balance of the company’s product portfolio.

We provide regular monitoring of Czech and Slovak legislation for a foreign company engaged in the production and distribution of medical devices in the Czech and Slovak Republics.

As part of this activity, we focus primarily on assessing the impact of the planned legislative changes on business activities and the company’s product portfolio. In addition, we regularly inform the company’s representatives about relevant events, new and other events in the Czech and Slovak healthcare sector, which are important for the medical devices agenda.

Based on the expert analysis of the upcoming changes, we propose to the company representatives appropriate steps to optimize the company’s internal processes.

The Czech distributor of medical devices asked us to submit a short seminar focused on working with the Register of Medical Devices.

At a two-hour seminar. we presented the issue of reporting obligations in the Register of Medical Devices in detail, explained many uncertainties, and also illustrated how individual applications for registration of activities and notification of medical devices can be submitted.

After this seminar, the company executive decided that there was no reason to outsource this activity to other companies, given the understanding of the issue and at the same time very easy to control the Medical Device Register.

The company, which is a distributor and importer of medical devices, has given us the entire reporting obligation agenda under the Medical Devices Act in the Register of Medical Devices.

Since the company also carries out the service of medical devices, we have prepared all the documents needed to report this activity in the Register of Medical Devices (these documents were of course prepared in a bilingual version for foreign producers).

At the same time, on the basis of getting acquainted with the company’s product portfolio, we also provided notification of all distributed and imported medical devices on the Czech market.

The Czech company, which has decided to redistribute medicines in the Czech Republic, has asked us for in-house training on good distribution practice.

We focused on the practical aspects of this issue and we introduced in detail the obligations arising from the Pharmaceuticals Act and the instructions of the State Institute for Drug Control.

The company was interested in importing good form outside the EU into the Czech Republic.

As it was a product on the border between a medicinal product and a medical device, at the of the client, we arranged its assessment and eventually the entire agenda of placing a medical device on the market.

Then, when the product was reported by the competition to SUKL as a “hidden drug”, we prepared arguments for administrative proceedings, including references to relevant EU documents. Thanks to our assistance, the administrative procedure for the client was successful.

A foreign company supplying medical technology to the Czech Republic has decided to participate in a public contract.

With regard to the optimized organizational structure, however, it has only sales representatives in the Czech Republic, with us providing the remaining agenda.

We conducted an analysis of the tender documentation and other terms of the public contract, prepared a summary of key information for the client’s management in English, a point list of documents and documents required by the contracting authority and further cooperated with the client’s headquarters so that the offer could be properly completed and submitted to the client in time.

The entire public procurement process was conducted in English without the need to have the tender documentation officially translated.