Government agency "State Institute for Drug Control" ( SÚKL )

Center of regulatory for Medical devices

The harmonization of medical devices under EU MDR means that medical devices are now subject to one single set of
regulatory requirements. This means that a medical device type-examined in one Member State can be placed on the
market anywhere within the EU. An organization in the Czech Republic which checks compliance with the safety of medical devices in accordance with the requirements of EU laws is State Institute for Drug Control.

The mission of the SÚKL is to ensure, for public health protection purposes, that only those pharmaceuticals which are of
good pharmaceutical quality, efficacy, and safety, be applied in practice and during clinical trials, that quality and safe raw
materials be used in the manufacture and preparation of pharmaceuticals, and that safe and functional medical devices with information describing objectively established properties be used and that data from the research of pharmaceuticals, raw materials, and devices be credible and obtained in an ethical manner.

competences of SÚKL

The competences of SÚKL include the following areas:
  • Prices and reimbursements – SÚKL decides on the maximum prices of medicinal products and on the amount and conditions of their reimbursement.
  • Borderline products – Issuing opinions/decisions in cases of doubt whether it is a medicinal product subject to registration or a medicinal substance or another product, or a homeopathic product, upon request or on one's own initiative.
  • Registration of medicinal products – Every mass-produced medicinal product is subject to registration before being placed on the market in the Czech Republic. As part of the registration process, documentation is assessed in which the future holder of the registration decision demonstrates the safety, efficacy and quality of the product.
  • Clinical evaluation of medicines – Assessment of requests for permission/announcement of clinical evaluation, supervision of the progress of clinical evaluations, issuance of opinions for the assessment of projects, if it is not a clinical evaluation regulated by the SÚKL, and records of the use of unregistered medicinal products.
  • Specific treatment programs – Issuing opinions on requests for specific treatment programs (SLP) for the Ministry of Health of the Czech Republic.
  • Dispensing, sales and preparation of medicines.
  • Pharmacovigilance – Supervision of medicinal products after their registration aimed at ensuring maximum safety and the most favourable ratio of the medicinal product's benefits to its risks.
  • Supervision of pharmaceutical production - Supervisory activities in the field of pharmaceutical production, good clinical and laboratory practice. It includes an agenda for solving defects in the quality of medicines and excipients available on the Czech market, issuing binding opinions on the import and export of medicinal products, including cooperation with customs authorities.
  • Human Tissues and Cells - Oversight of the donation, procurement, investigation, processing, storage and distribution of human tissues and cells to ensure their quality and safety.

our SERVICES FOR cooperation with SÚKL

Our company can help at any stage when interacting with SÚKL. First of all, as part of the services of an authorized representative, we can:
  • to register manufacturers and their medical devices directly in the national database NISZP .
  • to obtain an official conclusion on the class of risk for medical devices
  • to organize and carry out clinical trials for MD
  • to registrer medicines and preparations 

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