Medical Device Registration in
Poland
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
Medical Device Registration in Poland:
- 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