The law, which was adopted last fall, goes beyond EU regulations to introduce rules applying to every stage of the medical device lifecycle, says Tomáš Cihula, who leads Kinsellar’s life sciences and healthcare practice in Prague.
“There is no question that it will take all concerned stakeholders some time before they become comfortable with the challenges of the new legislation” such as more paperwork and heavier demands on the State Institute for Drug Control, or SÚKL, Cihula says.
Among other changes, the new law sets out the Czech Republic’s first legally binding regulations on clinical trials, including comprehensive provisions on performance evaluations and strict requirements for how evaluations should be conducted and reported.
The law also introduces a new Register of Medical Devices for manufacturers, importers, distributors and companies that service and repair medical devices. Previously, only manufacturers had to register these activities. The agency in charge of registering devices was also changed, from the Ministry of Health to SÚKL.
Higher Fines Imposed
The new law also requires devicemakers, importers and distributors to archive product safety documentation for five years and subject products to regular validation testing.
New sanctions have been introduced as well, including harsher penalties for violations relating to device safety and performance. The maximum penalty for an administrative breach increased from US $38,900 to $77,800.
More changes lie ahead, as clauses on device advertising and pricing were discussed but ultimately left out of the final law, Cihula says. In addition, a National Information System for Medical Devices is set to launch on April 1, 2018, and will provide information on devices to users, patients and healthcare providers.
On the plus side, Cihula says the law ends a confusing situation in which seven different entities shared oversight of devicemakers. Now most oversight will be handled by SÚKL, with the Ministry of Health covering the appeals process.