Distribution of Medical Devices across CEE

With little or no regulation on this subject in most of the region, some countries stand out by setting particularly strict conditions for distribution

In most countries throughout the region the law provides no specific regulation on distribution of medical devices (MDs), except for distribution of reimbursable MDs, since these may typically be sold only in pharmacies and with a doctor’s prescription. According to some general principles, distributors have to adhere to safety rules and other requirements applicable when placing MDs on the market; and sometimes they need to notify their business to the local sanitary authorities. In addition, they are bound to duly and closely cooperate with the regulatory authority, e.g. in case of recalls, storing documentation etc. (as in Poland, for example). But distribution of MDs as such is not connected with any particular pre-requirements, at least no different from those set for other types of wholesale activity.

Against this background, countries such as Bulgaria, Hungary or the Czech Republic stand out, with the bar raised particularly high for MD distributors.

Starting with Bulgaria, any duly registered entity wishing to engage in wholesale trade in MDs must apply to the Bulgarian Drug Agency. This involves considerable paperwork and a fee.

In Hungary the supply, rental and repair of medical devices may be undertaken if authorized by the relevant authority, and may be performed under the conditions laid down by the relevant legislation. Home delivery of medical aids may be carried out by distributors holding special permits, with the reservation that they cannot engage an agent for delivery of reimbursed medical aids.

Only a distributor duly registered with the State Institute for Drug Control can start distributing MDs in the Czech Republic. Distribution is subject to compliance with due distribution and good import practices.

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