Russian medical device registration certification is medical products exported to Russia is required to apply for the Russian medical device registration certificate, which is mandatory. If there is no medical device registration, is prohibited the import and sale. Whether in China, or the European Union, Russia and other countries, the medical device registration certificate is quite strict to ensure the quality, efficiency and safety of the product. Russian medical device registration certificates are divided into three classes, i.e. Class I, IIa, IIb and III. The higher the class, the more expensive the registration will generally be. Many companies in the registration of Russian medical device registration certification is the most concerned about is the Russian medical device registration certificate how much money? In fact, the cost of certification is related to the specific medical products. Before applying for the Russian medical device registration certificate, if the exporter has first applied for the medical device CE marking, it will also reduce the cost of applying for the Russian medical device registration certificate.
Russian medical device registration certification to apply for this certificate needs to be submitted documents:
1, application form
2, power of attorney
3, CE93/42 Declaration of Conformity
4, business license of the legal person of the enterprise
5, People's Republic of China **** and the State Organization Code Certificate
6, factory system Certificate
7, People's Republic of China *** and the country of medical equipment enterprise production license
8, People's Republic of China *** and the country of medical equipment products export sales certificate
9, Trademark Registration Certificate
10, Patent Certificate
11, CE certificate
12, product manuals (must be Russian)
13, product manuals
13, product manuals
14, product manuals
14, product manuals
16, product manuals
16, product manuals
16 p>13, product manual (must be in Russian)
14, promotional leaflet
15, clinical trial report
16, toxicology and biocompatibility and clinical laboratory report
17, samples and at least 3 outer packages (for our clinical trials, toxicology analysis, technical testing in Russia)