Medical registration

To export medical equipment to Russia, it is necessary to obtain the medical equipment license and GOST-R certificate issued by the Russian Federation Resident Health and Social Development Supervision Department (Roszdravnadzor). Without the medical equipment license and GOST R certificate issued by Russia, it cannot be sold and used in Russia. of. The validity period of the registration certificate is long-term.

        To obtain the GOST R certificate for medical equipment, one must first obtain a medical device license from the Ministry of Resident Health and Social Development Supervision of the Russian Federation.

One: Overview of the
       sale, use, and circulation of medical devices in Russia must obtain the medical device registration certificate issued by the Russian Ministry of Health and the corresponding GOST-R (DOC) certificate; the
       medical device registration certificate is valid for life;
       GOST-R (DOC) certificate 1 Valid for /3/5 years;

2: Main process
       1. Preparation of technical documents
       2. Notarization of documents
       3. Evaluation of technical documents
       4. Arrangement of samples to Moscow for testing (toxicology, etc.)
       5. Document evaluation, review, supplementation
       6. To Russian health Application submitted by the
       Ministry of Health and accepted 7. Russian Ministry of Health expert evaluation and review documents (Phase I)
       8. Clinical trials (determined according to the product)
       9. Russian Ministry of Health Expert evaluation and review documents (Phase II)
       10. Obtained Russian medical device registration Certificate
       11. Russian certification expert review and evaluation documents
       12. Obtained Russian GOST-R (DOC) certificate
     
3: Technical document list
       1. Authorization letter
       2. Application letter
       3. Manufacturer detailed information (accurate Chinese and English company name, address, Contact person and contact information, etc., if the registered address is different from the actual production address,
               Detailed descriptions are required);
       4. Manufacturer-related qualifications (valid business license, organization code certificate, tax registration certificate, trademark certificate, patent certificate, export license/free sales certificate, etc.);
       5. EU medical device CE certificate And declarations;
       6. ISO13485 certificate (within validity period);
       7. Product information (accurate product name, model, parts list, customs code, etc.);
       8. Product brochure;
       9. Product manual (English or Russian) Text, including the intended use of the product, use requirements, sterilization requirements, etc.);
       10. Product drawings (outline drawings, electrical drawings, packaging drawings);
       11. Product label drawings (English or Russian);
       12. Product test reports (Functionality, toxicology, clinical reports, CE test reports, etc.);
       13. Risk analysis;
       14. Others;

the import ban on medical products has been lifted from Russia, and more and more medical products in China are about to enter Russia and other countries of the Customs Union market. Among the influx of medical products, only products that have passed the formal procedures for certification can be successfully sold in the Russian market. Therefore, medical certification and registration are the most important, the most important of all.
In addition to the above-mentioned Russian medical registration, our company can also handle CE certification, Customs Union EAC certification, GOST certification and product CE certification, Africa Nigeria Soncap, Kenya PVOC, Tanzania COC certification and other countries and regions export and product certification , Is a trusted partner of the enterprise, helping you set sail in the international market