State registration of medical products

Registration of medical products in Russia

Pursuant to Article 38 of RF Federal Law No. 323-FZ dated 21.11.2011, which deals with issues of public health and welfare in our country, only medical products that have undergone state registration procedures in the established manner can be cleared for release onto the Russian market. The registration rules are set forth in an additional regulation – RF Governmental Resolution No. 1416 dated 27 December 2012. The state agency responsible for the organization and performance of this procedure is Roszdravnadzor.

Risk classes of medical products

The algorithm for the performance of state registration is differentiated, depending on the product’s specific type. Differentiating among the various categories of such products is achieved by using the interstate standard GOST 31508-2012, which establishes a number of risk classes for such products, depending on the potential harm that could be caused to the patient’s health as a result of their use. This standard introduces the following risk classes:

• 1 – low level. Assigned to basic products that cannot cause serious harm to patient health. For example, this category usually applies to disposable shoe coverings, medical masks, etc.
• 2a – moderate level. Assigned to diagnostic equipment, bandages and dressings, etc.
• 2b – elevated level. Assigned to apparatus intended for the administration of medicinal drugs, devices for the administration of anesthetics, etc.;
• 3 – high level. Assigned to apparatus intended for the performance of complicated manipulations, implantable materials, etc.

The procedure for the state registration of such products considers the possibility of their harmful impact on the human body, which is why products assigned to the higher risk classes are subject to more stringent requirements.

State registration of medical products: general procedure

The broad contours of the mandatory state registration of medical products according to the provisions of Resolution No. 1416 are as follows:

• drafting of the documents that will form the basis of the registration dossier;
• performance of technical and toxicological testing, resulting in a determination of the product’s level of quality and safety for patients. Such tests are performed by the authorized organizations found on Roszdravnadzor’s special list. For products assigned to risk class 1, that is – products characterized by the lowest-possible risk for the person using them, this stage also includes the performance of clinical trials confirming the respective product’s efficacy;
• compilation of the final set of documents forming the compulsory dossier and submission of the dossier, together with the corresponding registration application, to Roszdravnadzor; consideration of the application by Roszdravnadzor in terms of the completeness and proper compilation of the submitted documents. Roszdravnadzor is given 5 business days to complete this step. If the department doesn’t find any serious errors based on these criteria, it makes the decision to proceed with phase I expert evaluation. For products assigned to risk class 1, phase I expert evaluation is not conducted, since the data on the results of clinical trials for such products are obtained prior to the final compilation of the dossier;
• performance of phase I expert evaluation by an authorized organization. At this stage, the organization conducts a careful analysis of the contents of the documents forming the dossier in order to reach a conclusion as to the feasibility and possibility of clearing the product for clinical trials that would allow for an objective determination of its level of quality, safety and efficacy. The findings reached by the expert organization are drawn up in the form of a conclusion. The organization is given 20 business days for its preparation and compilation;
• handover of the expert conclusion to Roszdravnadzor for the making of a decision on the scheduling of clinical trials;
• performance of clinical trials for the medical product, in cases where Roszdravnadzor has made a positive decision on the product. These trials are conducted by an authorized medical organization found on the special list compiled by the department. The results of the trials are drawn up as a report per the established form, which is then submitted to the oversight agency;
• Roszdravnadzor’s consideration of the results of the completed clinical trials and making of a decision on the scheduling of phase II expert evaluation. This stage is scheduled for all categories of medical products irrespective of the class of the potential risk associated with their use, including products assigned to risk class 1;
• performance of the phase II expert evaluation of the product’s quality, safety and efficacy by an expert organization. Within the scope of this stage, specialists analyze the results of the clinical trials and technical/toxicological testing conducted on the product in order to reach final conclusions on its medical characteristics. These findings are drawn up in the form of an expert conclusion, which is then submitted to Roszdravnadzor. The organization is given 10 business days for the completion of this work;
• submission of the expert conclusion to Roszdravnadzor for consideration and the making of a final decision on the possible state registration of the product;
• registration of the medical product and issuance of the corresponding registration certificate, in the event that Roszdravnadzor’s decision is positive.

In total, the entire state registration procedure, according to the requirements of Resolution No. 1416, should take no more than 50 business days. That said, this timeframe does not include the clinical-trial period, since the duration of such trials is highly dependent on the complexity of the product, the possible detection of unexpected consequences stemming from its use, and other factors.

Accelerated registration of medical products

The full procedure involving the registration of medical products in Russia is rather complex and lengthy. What’s more, federal legislation provides no exclusions: medical-product registration must be completed by each and every product prior to being stocked on the shelves of pharmacies and other commercial organizations. Thus, against the backdrop of the COVID-19 pandemic, which has prompted a surge in demand for personal protective equipment (PPE), the RF Government has made a decision on the introduction of a special temporary algorithm.

To that end, it has adopted two special resolutions. The first, RF Governmental Resolution No. 299 dated 18 March 2020, introduced a separate accelerated procedure for the 36 most sought-after PPE, including face masks, respirators and gloves. Per this resolution, the simplified registration of medical products is performed on the basis of the manufacturer’s submission of a minimal set of corresponding documents. The set includes photographs of the product, its operational and technical documentation – as developed by the manufacturer, and certain administrative paperwork.

Roszdravnadzor is expected to review the set of documents within 5 business days, and within the same timeframe – to process and issue a valid certificate allowing for the sale of such products within the territory of the Russian Federation. However, the validity period of such a certificate is limited to 150 days. Within this timeframe, the manufacturer is de facto required to complete all of the standard state-registration procedures it has not yet undergone, including the performance of the necessary tests, and thereafter to submit the corresponding confirming documents to the oversight agency in order to obtain a certificate with an indefinite validity period.

RF Governmental Resolution No. 430 dated 3 April 2020 introduced a somewhat different but similarly accelerated procedure for a more expansive list of products encompassing more than 360 specific items. Pursuant to this resolution, the applicant provides Roszdravnadzor with a full set of documents, including the results of any completed tests, right at the first stage of registration. However, unlike the standard algorithm, in this case the manufacturer is permitted to conduct testing according to a simplified method, which is to be developed by an authorized expert organization. The specialists at the Center for the Registration of Medical Products have a wealth of experience in the organization of registration procedures for a wide range of different product types. We offer services involving the registration of medical products according to both the standard algorithm and its simplified counterparts. Thanks to our smooth coordination with accredited laboratories, coupled with our intimate knowledge of applicable legislation, we can guarantee our clients the problem-free completion of state-registration procedures and their swift receipt of the corresponding certificate.