Ministry of Health:     

Ministry of Health

Regulatory Authority:          

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)

Medical Device Regulation:          

Act on Medical Devices (May 20, 2010) (Journal of Laws of 2015, item 876 as amended)

Official Language:      

Polish

Classification:    

Class I, IIa, IIb and III

Registration Process:

• Appoint an Authorized Representative and Notified Body
• Determine the device classification
• Notify the Competent Authority at least 14 days in advance before placing the device on market or submitting it for evaluation.
• Complete the application form and required documents
• Submit a paper version and electronic copy of the document to the URPL
• Notified Body carries out Conformity Assessment
• Once approved by the Competent Authority, a device may be marketed in Poland

Documents Required:          

• Proof of payment
• Declaration of Conformity
• Certificate of Conformity
• Letter of Authorization for Authorized Representative
• Labels or Artworks, IFUs, Promotional materials
• List of laboratories or institutions involved in product performance evaluation
• For foreign manufacturers, a Certificate of business activity from outside Poland authority issued not earlier than 3 months from the date of submission
• Identity proof
• Power of Attorney

Post-market surveillance:  

Timely reporting of the incidents should be made to the President of the Office

Applicable QMS:          

ISO 13485

Registration Timeline:         

Class I – 4-6 weeks

Others – Depends on the timeline of Notified Body

Authorized Representative:          

Yes

License Validity:          

• years

Special Notes:    

• The manufacturer or Authorized Representative should notify the President of the Office at least 14 days before placing the product on market or submitting it for evaluation.
• Samples of artwork and promotional material may be requested