7) Documents relating to the manufacturer's Final Quality Control. 6) Declaration that the distributor can carry out servicing both during the period of warranty and beyond and that spare parts can be supplied 5) Copies of foreign certificates, if available. 4) A statement of authorization of the Polish representative, who will be responsible for the registration.
#WARSOW REGISTRATION MANUAL#
3) Service Manual in Polish (or English, German, or French) language
1) The application form, completed by the distributor With an application for registration, the following must be included:
#WARSOW REGISTRATION REGISTRATION#
Registration is based on technical testing and clinical evaluation. Registration is done by the Research Center of Medical Technology in Warsaw. Medical equipment does not require additional tests for the Polish "B" safety certificate, which is required for many other types of equipment. Certification is issued for a period of five years with the possibility of extending it for another three years. If the producer is not already known by the certification agency, or the equipment is complicated, it may also require clinical tests. The applicant may be an authorized representative or a distributor of a foreign supplier. A company registered in Poland must make the request for registration. 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. It is crucial to have a Polish partner or representative to assist with the complicated certification process. 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. 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. Medical equipment has been and still is subject to pre-market testing and approval in Poland. 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. There are also negotiations to establish a Protocol for the European Conformity Assessment between Poland and the European Union.
Poland is in the first wave of applications for accession to the European Union, which should happen around 2002. Poland is in a transition period, between the old state regulations and a new system based on the Medical Devices Directives. The range of medical equipment produced in Poland is quite limited. 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. German and British companies are the strongest competitors for American firms. About 75% of all medical equipment used in Poland is imported. For detailed and definitive information about a country's laws and policies, the government of the country concerned should be consulted. Disclaimer: The information contained on this website is derived from public sources and is current to the best of our knowledge.
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