Since Poland joined the EU in May 2004 the level of interest in the market for medical devices has expanded considerably. There are two fundamental questions that any international medical device manufacturer should ask before attempting to enter into the Polish market:
- Is there a market for their product in Poland, either in the state funded sector or in the small but growing private sector?
- What has to be done to gain regulatory approval? The possibility of using existing European Union registrations to gain approvals in Poland is obviously of great interest.
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