Czech Republic Sets Stringent Regulations for Devicemakers

Devicemakers doing business in the Czech Republic face a steeper regulatory burden than before, thanks to regulations that took effect April 1. The new law 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.

The law, which was adopted last fall, goes beyond EU regulations to introduce rules applying to every stage of the medical device life cycle, says Tomáš Čihula, who leads Kinstellar’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, Čihula says.

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.

On the plus side, Čihula 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.

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