For successful sales of medical goods,it's important to comply with rules of applicable legislation of our country and thoroughly construct strategy of product market activity from import of products or their domestic production to supplies to medical facilities with their further application in accordance with instructions.

Manufacturers often have various questions especially related to initial registration of products. For example, why it's better to obtain MA and why this procedure is mandatory, what's the difference between registration of domestically produced and imported products, if all the medical products are subject to this procedure, etc.

Registration of medical products is a mandatory requirement for legitimate utilization of products in the market, which is strictly regulated by the Russian legislation. That's why all medical products and equipment , should mandatory undergo a procedure of quality and safety assessment. There are 2 legalised documents in Russia:

• Roszdravnadzor marketing authorisation
• Declaration of conformity

Both of these documents require an individual conformity confirmation procedure and are issued by various authorities.

Obtainment of Marketing Authorisation is not a simple task which requires professional approach and large efforts. Before registration, it's necessary to study medical products, to understand their features, functionality and area of future application. That's why, before starting any related actions, you shouldn't forget to consult experts in this area. Qualified support will help achieve results quickly.

The state registration of medical products in Russia is performed in Roszdravnadzor. It's the agency, which issues mandatory permits allowing legal utilization of medical equipment in our country. If you decided to register a medical product, you have to prepare a Registration Dossier, conduct all mandatory tests and submit the dossier to RZN.

The process of registration of medical products - is a multi-task step-by-step structure requiring good preparation, knowledge of regulatory aspects and skill of prompt response to changes in the legislation. In other words, if you want to obtain MA at the first attempt and in strict compliance with the regulations, you can't do it without serious preparation as well as practical experience and knowledge allowing to pass this procedure from the beginning to the end.

Do you know that Marketing Authorisation of medical products ,has no expiration date and is issued in a state-recognised format?

Yes, it's absolutely right, but the structure of the form can change in case of amendments to regulatory acts!

And now let's check it out and scrutinize the stages of state registration of medical products….

Before starting this diligent work, it's better to find out who is the developer of the products, who is their manufacturer, where are the production sites located and how many of them exist. And what if the production site is located outside Russia? In this case, the foreign manufacturer should have a Russian representative authorised to provide technical support, repair the device, and collect reclamations from consumers.

Now let's find out, which list of documents for registration of medical products the applicant should submit:

• Certificate of incorporation
• Certificates for materials
• Manufacturing documents
• Technical information about the product
• Operational instructions

• Register extract for the manufacturing company
• Power of attorney for the authorised representative
• Information about the Russian applicant
• Excerpt from the technical file
• Operational recommendations
• Foreign protocols

All documentation should be checked thoroughly and all legal data such as the company's name and place of business should be compared. There should be no deviations but in case there are some, it's necessary to request explanations from the manufacturer as a clarification letter.

When filling in the registration statement, it's important to write down the name of the product correctly, specify its models/design options, its composition, accessories, as well as define its risk class and OKPD-2 code.

If all the documents are ready, you can start tests for registration. Large-format medical equipment , which is no subject to delivery to laboratory should be tested on the manufacturer's site. The specialist of the laboratory will conduct assessment of technical safety of the product on-site. Such measures are often taken for large-format X-ray equipment. And the registration of medical equipment , of such format can last for up to 12 months or longer.

After testing, the registration set of documentation for the product is formed for submission to the registering authority to undergo further registration procedure. After submission of the dossier to RZN, the applicant will be given a registration number by using which it can track all the stages of the registration process.

We'll prepare the registration dossier dossier for you within 14 days, and we will conduct the tests within 21 days after we get all the materials.

Review of the documents submitted by the applicant

Completeness check of RD
(5-7 business days)

Resolution on the start of registration
(3 business days)

Task for carrying out of assessment

1 stage of the quality and safety (20 business days)
(Request for additional materials and information (if
necessary) - 50 business days)

Conclusion report of the expert organisation

Positive conclusion -
certification for the clinical trials

Notification of corrective actions to the applicant
(at the stage of the documents review)

In case the mistakes are not corrected,
the application and all the documents are returned to the applicant

Negative conclusion - denial of
registration

• A contract with a medical organisation will be in place
• RZN is informed about the start of clinical trials
• The schedule and methodology of the clinical trials will be developed
• The Registration Dossier for the medical product is formed and submitted to the testing facility with the samples
• Then the medical product registration procedure is suspended

Issued reports and a letter with a request about restart of this procedure are submitted to RZN after which the 2nd stage of the efficiency confirmation of the registered medical product starts.

By the way, the procedure of clinical trials for the 1st risk class medical products is simplified and performed during formation of the registration dossier. Medical furniture, clothes, and orthopaedical accessories are registered in such way. Therefore, all the above categories of products are of the first risk class.

Registration of medical products is not a simple process but it's quite possible to obtain the marketing authorisation within 6 months if the following conditions are met:

• Information is submitted in full
• All documents from the applicant, as well as the certificates for products and manufacturing are available
• Process of legalisation and confirmation of the documents complies with regulations
• Application form is completed correctly and classification of the medical product, accessories and design options perfromed
• Samples are imported to Russia under a permit and not "as luggage"
• Applicant timely provides all additional information requested by Roszdravnadzor
• A competent specialist prepares all the documents

Our specialists visit the production site and select all necessary documents by themselves or provide an exact content of the sections of the technical documentation to your representative. This will sufficiently shorten the period of preparation of the registration dossier, reduce the cost of translations (for foreign manufacturers) and influence the period of registration on the whole, Eliminating risks of denials on every stage of registration.

Trust our experts — they use knowledge and don't depart from rules!

The period of the registration process is 6–8 months after submission of RD to RZN.

The cost of the turnkey registration contract is equal to ₽750,000 provided that all the documents are available. Payment is performed under the contract in 5 installments after each one the result of work is provided.

Quite often, while starting the registration process, the manufacturer is not able to submit all the required technical documentation for the medical product, there is only a technical specification (TU), and sometimes even it has not been developed.

But there is a way out of this situation...

Our experts will use their long-term experience to prepare (develop) all necessary documents to help you successfully pass the medical product registration process.