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(Roszdravnadzor) is responsible for the registration of medical equipment, tools and materials for the Russian Federation (Roszdravnadzor). At the same time, the medical device registration certificate or certification body issued GOSTR certificate basis. Medical equipment if there is no medical device registration certificate is not possible to apply for GOSTR certificate.
Any medical products in Russia include: Category 1, Category 2, Category 3 Medical Devices in Russia, if no registration of Roszdravnadzor medical devices, is prohibited for import and sale. Medical Devices National Register has a very rigorous testing and evaluation process in Russia to ensure the quality, efficiency and safety of the product.
Implementation of new medical device regulations in April 2013. Russian Union regulations Федеральный закон РФ «Об основах охраны здоровья граждан в Российской Федерации» от 21 ноября 2011 г. N 323。
Required Documents：
1、Application Form
2、Power of attorney
3、CE 93 / 42 Declaration of Conformity
4、Business License
5、The organization code certificate of the People's Republic of China
6、ISO13485 system certificate
7、The People's Republic of China medical equipment production license
8、Certificate of free sale
9、Trademark registration card
10、Patent certificate
11、CE Certification
12、Product brochures
13、Product manual
14、Publicity color pages
15、Clinical trial report
16、Toxicology and biocompatibility and clinical laboratory reports
17、Tamples and at least 3 outer packaging (for our clinical trials in Russia, toxicological analysis experiments, technical tests)
Russian medical device registration certificate notarized information
Russian medical registration certificate to the China Council for the Promotion of International Trade (Russian Embassy / Consulate in China) notarized information is as follows:
1．Application form
2．Power of attorney
3．CE 93 / 42 Declaration of Conformity
4．Corporate legal person business license
5．Business License
6．ISO13485 system certificate
7．The People's Republic of China medical equipment production license
8．Certificate of free sale
9．Trademark registration card
10．Patent certificate
Fire safety certification process
1. The applicant apply for certification;
2. The certification body confirms the certification mode and the implementation plan according to the product information;
3. Prepared by the applicant to submit the certification required for certification information;
4. According to the certification model to determine whether the need for sample testing or factory audit;
5. Audit factory’s qualification and materials, issue draft certificate
6. Issue the original
