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