Doctors and healthcare

Doctors
Medical facilities and social services residential facilities

Public procurement

Contracting authorities
Applicants

Manufactures and distributors

Medical devices
Medicines
Foodstuffs

Non-profit sector

Associations
Patient organizations

Medical devices

How do you manage the Medical Device Registry without spending needless time trying to figure it out? Are you unsuccessful adding a medical device into the Reimbursement catalogue?

The first consultation is FREE

Let us know, although you are not sure, if you would use our services.

+420 739 299 826
info@remedical.cz

Typical services

Registration and notification in Registry of medical devices (RZPRO) in accordance with the law on medical devices

We will help you with all the RZPRO agenda – from activity announcements, before mass notification, communication with SÚKL, preparation of documents to evaluation of the instructions for use.

Strategic counselling

We will assist you with complete product entry preparation, including regulatory and government affairs – analysis of opportunities or threat.

Counselling in the area of public procurement

We will help you prepare a strategy for participation in public procurement and set up the company’s internal processes as a applicant of public procurement and then a contractor.

Training and seminars

Prepare for training and targeted seminars of your interest. Healthcare workshops can be implemented through lifelong learning.

Border products

We will help you assess the products in terms of their nature as a medicine, medical device, cosmetics, food or food supplement. We will also advise on regulations, duties and health claims. And we will also help with labels and product packaging.

Calculation of reimbursement from public health insurance

We will prepare for you calculations for the selected performances with specific medical devices with the issue of ZUM, coefficients according to the reimbursement decree, etc.

Incorporation of medical devices into the Payment Catalogue of health insurance companies

We will fully arrange the agenda with the inclusion of medical devices in the Payment Catalog (Codebook) of VZP ČR and the Association of Health Insurance Companies, incl. preparation of documents and completion of the application, including all communication and representation in price negotiations.

Typical examples

Product portfolio analysis of manufacturer and distributor of 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.

Targeted monitoring of CZ and SK legislation and institutions

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.

Individual training focused on practical aspects of working with the Registry of medical devices (RZPRO)

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.

Notification of medical devices and registration of work in Registry of medical devices

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.

In-house training for sales representatives on the topic of reimbursement ordinance

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.

Border product

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.

Inclusion of medical devices in the Reimbursement catalogue

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.