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The Medical Devices Section of the State Institute for Drug Control (KL) is responsible for regulating devices in Slovakia.
CLASSIFICATION SYSTEM: Medical devices are divided into Classes I, IIa, IIb, and III based on the level of risk they pose. TIMEFRAME: For Class I devices, the EU registration procedure takes a few weeks following submission.
The agreement with the notified body and the type of equipment are key factors for the other classifications.
Forecasts in the Slovakia Medical Devices are supported by projections for trade, production, and healthcare. Consumables, Diagnostic Imaging, Dental Products, Orthopaedics & Prosthetics, Patient Aids, and Other Medical Devices are the six product categories that are the subject of these forecasts and estimates.
Manufacturing of medical devices in Slovakia has a long history, especially in the fields of orthopaedic and dental apparatus. Currently, the majority of medical equipment produced by Slovak businesses is single-use.
Slovakia medical devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
In order to increase its presence in these regions and solidify its position as the market leader in Europe for Medical Dermatology, a biopharmaceutical business that focuses on skin health has announced the launch of a new affiliate for the Czech Republic and Slovakia.
The recently appointed General Manager for the Czech Republic and Slovakia, will oversee the subsidiary from Prague.
Almirall has decided to pursue the launch of new products in the Czech and Slovak markets in order to expand its current Medical Dermatology product portfolio there, where the business has up to this point been commercialising through distributors.
The company recently secured approval of the reimbursed pricing for Ilumetri (tildrakizumab), an anti-IL-23 biologic for the treatment of adult patients with severe chronic plaque psoriasis, in these two countries, and this month began its commercialization.
Almirall currently has 14 worldwide affiliates strategically positioned in Europe and the United States and is active in more than 70 nations as a result of the inclusion of these new subsidiaries. In this way, the business maintains its global strategy to address unmet dermatological illness patient needs all over the world.