What Class 1 Medical Device Registration is required to sell in Poland

[chris1price]

Hi all

We currently have a device on sale throughout most of Europe. It is CE Marked and Class 1 under the MDD. Does anyone know what additional registration is required to sell in Poland?

Thanks

[Al Rosen]

Originally Posted by chris1price

Hi all

We currently have a device on sale throughout most of Europe. It is CE Marked and Class 1 under the MDD. Does anyone know what additional registration is required to sell in Poland?

Thanks

From the US Government web site at: http://www.ita.doc.gov/td/health/polandregs.html

Medical Device Regulatory
Requirements for
Poland

Disclaimer: The information contained on this website is derived from public sources and is current to the best of our knowledge. For detailed and definitive information about a country's laws and policies, the government of the country concerned should be consulted.
About 75% of all medical equipment used in Poland is imported. German and British companies are the strongest competitors for American firms. Polish manufacturers are not very competitive because of high production costs, lack of modern technology, low quality products and lack of marketing skills and resources. The range of medical equipment produced in Poland is quite limited.
Poland is in a transition period, between the old state regulations and a new system based on the Medical Devices Directives. Poland is in the first wave of applications for accession to the European Union, which should happen around 2002. There are also negotiations to establish a Protocol for the European Conformity Assessment between Poland and the European Union. This will enable the new laws to develop and let Poland function as if it were a part of the EU, all at the same time. Medical equipment has been and still is subject to pre-market testing and approval in Poland.
Regulatory System
Medical equipment, new and used, for use in public hospitals and/or private clinics and medical centers must be certified by the appropriate Polish authorities. Any equipment offered in public tenders must have initiated the registration procedure in order to be permitted to participate in a tender, and the procedure must be completed before any contract is signed. It is crucial to have a Polish partner or representative to assist with the complicated certification process.
The certification requirement is regulated by the Minister of Health and Social Welfare's Regulation on Certificates of Medical Apparatuses and Equipment acquired by Health Care Institutions of March 11, 1992, which can be found in government publication Dziennik Ustaw (Journal of Law), Dz. U. 31/92 item 135.
Registration
A company registered in Poland must make the request for registration. The applicant may be an authorized representative or a distributor of a foreign supplier. All equipment is tested technically. If the producer is not already known by the certification agency, or the equipment is complicated, it may also require clinical tests. The procedure takes about nine months. Certification is issued for a period of five years with the possibility of extending it for another three years. Medical equipment does not require additional tests for the Polish "B" safety certificate, which is required for many other types of equipment.
Registration is done by the Research Center of Medical Technology in Warsaw. Registration is based on technical testing and clinical evaluation. With an application for registration, the following must be included:
1) The application form, completed by the distributor;
2) Operation manual in Polish
3) Service Manual in Polish (or English, German, or French) language;
4) A statement of authorization of the Polish representative, who will be responsible for the registration.
5) Copies of foreign certificates, if available.
6) Declaration that the distributor can carry out servicing both during the period of warranty and beyond and that spare parts can be supplied;
7) Documents relating to the manufacturer's Final Quality Control.
It is important the submissions made are accurate, and that the local representative follows up on these submissions. The certification procedure can take between 9 months and 2 years. Registration is valid for 5 years.
Certification
Medical equipment, new and used, for use in public hospitals and /or medical centers must be certified by the appropriate Polish authority. Also, equipment and apparatus that for procurement in public tenders must have at least initiated the certification procedure must be completed before the contract is signed.
When starting the Polish product certification process, it is important for U.S. manufacturers to note the following:

• When any company applies for certification, the Polish certification law allows representatives of Polish certification bodies to visit the company's manufacturing plant to verify that the products are being manufactured under appropriate conditions. Companies, including U.S. firms with manufacturing operations in the U.S. or other countries, must cover the entire cost of such visits.
• Certificates are not issued for a specific product but to the applicant. This means that if one company receives a certificate for a particular product and later the same product will be marketed by a second company, the second company must also go through the certification process. U.S. companies should keep this in mind when they contemplate authorizing their agent or distributor in Poland to obtain certification for their product. Some U.S. companies wisely arrange for the agent or distributor to assist them in obtaining the certificate in the name of the U.S. company.
• When products are sold directly to end-users and will not be put on the market for further sale or marketing, a certificate is not required.
• American exporters should be aware that the electrical voltage in Poland is 220 and the current frequency is 50 Hrz. Power cables and plugs must be consistent with Polish Standards.

Application requirements and procedures are usually complicated and take time. A company planning to introduce a product on the Polish market should be prepared to wait for several months before the certification process is completed and the certificate issued.
Standards:
Testing by the Research Center of Medical Technology is carried out by the Polish national standards which are based on IEC 601, but may contain local variations.
Language/Labeling:
Labeling and instructions for use must be in Polish. Technical documentation and certificates as required for the submission can be other languages: English, German or French.
Contacts:
The following office is responsible for certification of medical equipment:
Centralny Osrodek Techniki Medycznej
(Medical Technology Center)
ul. Boduena 4
00-950 Warszawa, Poland
Contact: Mr. Antoni Kazmirowski, Chief, Certification Department
Tel: (48 22) 827-8051, ext. 41
Fax: (48 22) 827-8791


To purchase the official register of already certified medical equipment and devices, contact:


Centralny Osrodek Techniki Medycznej
(Medical Technology Center)
ul. Boduena 4
00-950 Warszawa, Poland
Contact: Ms. Irena Janicka
Tel: (48 22) 827-8051, ext. 49
Fax: (48 22) 827-8791


Medical and dental materials and supplies are certified by:


Biuro Rejestracji Srodkow Farmaceutycznych i Materialow Medycznych
(Bureau of Drug and Medical Materials Registration)
ul. Chelmska 30/34
00-725 Warszawa, Poland
Tel: (48 22) 41-2393, 651-4381, 651-4382
Fax: (48 22) 41-2393, ext. 199
Contact: Mr. Tomasz Krasucki, Director (materials)
Tel: (48 22) 41-23-93, ext. 136 or ext. 180
Ms. Irena Wacowska or Ms. Elzbieta Maciejowska (supplies)
Tel: (48 22) 41-23-93, ext. 102


For additional information on medical equipment (duty free quotas, central purchasing plans,
etc.), contact:


Medical Technology Department
Ministry of Health and Social Welfare
ul. Miodowa 15
00-952 Warsaw, Poland
Tel: (48 22) 831-3441, ext. 425
Fax: (48 22) 635-9407
Contacts: Mr. Piotr Zalewski, Director
Tel: (48 22) 826-2144
Mr. Krzysztof Dziolko
Tel: (48 22) 831-39-94

[chris1price]

Thanks Al

This is a really good site for information. Infortunately, the Polish entry appears to be written before their entry into the EU and does not discuss whether CE Marks are accepted.

I have seen other sites saying that the implementation of the MDD was delayed in Poland but not what the current situation is. Has anyone got first-hand experience of registration in Poland in the past couple of years and is registration still required for CE Marked product?

Thanks

[harry]

Some information in the attached document may be useful for you.