In the current scenario of COVID-19, Ventilator is considered as one of the critical products for immediate supply. But with the decline in the global supply chain of Ventilator, meeting the demand right on time would be challenging.
To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent Ventilator manufacturer you might be willing to market your product across the globe or to be specific in Slovakia. But do you know how ventilators are classified in Slovakia? How the State Institute for Drug Control (SUKL, Slovak: Štátny ústav pre kontrolu liečiv) regulates ventilators?
Have all your questions answered regarding:
- Medical Ventilator Registration/Notification in Slovakia
- SUKL Ventilator Regulations
- Ventilator GMP as per the SUKL
In addition, some global health authorities have already expedited their Regulatory pathways for ventilator. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline ventilator global market entry with the best of regional Regulatory information and structural Regulatory approach.
As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registration/notification of medical ventilator in Slovakia.