Processing of registration certificates

Article 38 of RF Federal Law No. 323-FZ dated 21.11.2011, which deals with issues of public health and welfare, establishes that only products that have undergone mandatory state registration procedures can be cleared for release onto the Russian market. This condition was introduced to protect the public from the risks associated with purchasing counterfeit or substandard products. Confirmation of undergoing state registration is the registration certificate, drawn up per the standard form.

Obtainment of a registration certificate for medical products

The state registration procedure, which culminates in the issuance of the respective certificate, is prescribed in a separate regulation – RF Governmental Resolution No. 1416 dated 27 December 2012. The resolution indicates that in order for such a document to be issued, the applicant must complete the following stages:

• performance of technical and toxicological testing, with the recording of their results in documents per the specified form. For products classified under the interstate standard GOST 31508-2012 as falling within potential usage-risk class 1, clinical trials are also conducted at this stage;
• compilation of the registration dossier, to include, among other things, the respective test reports;
• submission of the dossier to the state agency responsible for the registration of medical products (Roszdravnadzor);
• Roszdravnadzor’s consideration of the set of documents and, provided the absence of errors in their compilation and processing, initiation of phase I expert evaluation of quality and safety. For products classified under risk class 1, phase 1 expert evaluation is not conducted;
• performance of phase 1 measures by an authorized expert organization found on Roszdravnadzor’s approved list, during which area specialists study the content of the documents forming the registration dossier. Formalization of the resulting findings in the form of an expert conclusion, which is then handed over to the oversight agency;
• consideration of the expert conclusion by the responsible department and the scheduling of clinical trials;
• performance of clinical trials by an accredited medical organization and the submission of reporting on their findings to Roszdravnadzor;
• consideration of the reporting and scheduling of phase II expert evaluation of quality and safety. This stage is implemented for all categories of medical products, irrespective of their usage-risk class;
• performance of phase II expert evaluation, during which the findings of the completed clinical trials are studied, and compilation of an expert conclusion on the test results;
• submission of the expert conclusion to Roszdravnadzor and the issuance of a final decision on the possible state registration of the product;
• processing of RC for the respective medical products and their issuance to the applicant.

Companies that need to obtain a registration certificate for their medical product pursuant to Resolution No. 1416 should allow up to 50 business days for this process. However, this period does not include the duration of the respective clinical trials, since their length can be highly dependent on the properties of the product being submitted for registration.

Medical registration certificates

Consideration of the application and processing of the certificate is a paid state service. In order to figure out how much a registration certificate for a particular medical product might cost, the applicant should study the provisions of Article 333.33 of the current RF Tax Code. Clause 1(1) of this section of the regulation indicates that the state fee for the issuance of an RC for a medical product is RUB 7,000. It’s important to remember, however, that this stage is preceded by other mandatory procedures that will also be paid. Their cost will depend on the risk class assigned to the specific medical product. For example, the expert evaluation of the product’s quality, safety and efficacy will cost the applicant somewhere in the range of RUB 45,000-115,000. Pursuant to Clause 56 of Resolution No. 1416, the RC will reflect the following information:

• product name;
• date of its state registration and registration number;
• name of the company in whose name the certificate was issued, its form of incorporation and address;
• the same information for the product’s manufacturer;
• location of the product’s manufacture;
• number of the registration dossier;
• the product’s risk class, as determined per the criteria set forth in the interstate standard GOST 31508-2012;
• product code per the All-Russia Classifier OK 034-2014.

The registration certificate can be drawn up in traditional paper or electronic form. In the former case, it’s sent to the applicant by registered mail with notice of receipt. In the latter case, the RC can either be sent in the form of an electronic document signed by electronic digital signature (EDS), or sent in electronic form over telecommunications channels. The Center for the Registration of Medical Products offers a comprehensive service for the handling of registration applications with Roszdravnadzor. Our specialists organize and perform the testing of products, help in the compilation and collection of the required documents, submit documents to the responsible department and oversee the process of the application’s processing – up to and including your receipt of the resulting registration certificate.