At the moment, there is an increased demand for certain categories of medical devices in the Russian Federation. As a result, the Russian Government has introduced measures to significantly simplify and accelerate the state registration procedure, which allows domestic manufacturers and distributors to obtain accelerated registration of medical devices. For this purpose, a list of mandatory documents has been approved, which significantly simplify and speed up this procedure. This facilitates the rapid entrance of medical devices to the market.
In order to prevent the spread of infectious diseases, accelerated (simplified) registration of more than 300 medical devices is permitted. Among the main medical devices on this list are the following:
- Artificial circulation system;
- Artificial lung ventilation devices;
- Shoe covers;
- Medical gloves;
- Wound oxygenating systems and oxygenators;
- Respiratory apparatus and medical protective masks;
- COVID-19 tests;
- Thermometers;
- Surgical and medical overalls and scrubs;
- Various personal protective equipment and other medical devices.
In addition to the registration procedure for medical devices regulated by Decree No. 430, there is another accelerated registration procedure. State registration of low-risk medical devices is allowed for the list of devices noted in the Decree of the Russian Federation No. 552 of 01.04.2022, which refers to the peculiarities of registration of medical devices in case of inventory shortage or risk of inventory shortage. They can be registered without conducting studies, tests and trials. And all the necessary studies should be carried out after registration and obtaining a registration certificate from Roszdravnadzor.
Registration of medical devices included in the above lists is quite simple and takes no more than a few days. The process itself will be described in more detail below.
Accelerated Registration of Medical Devices: Process and Features
Owing to the introduction of simplified procedures for obtaining registration certificates, the registration process itself has become much simpler and faster. Having obtained a registration certificate from Roszdrav, it is possible to legally sell medical devices.
Depending on the chosen method of registration, it is possible either to conduct simplified tests of a series (batch) of a medical device according to programmers developed by experts in laboratories with the necessary accreditation, and in the shortest possible time obtain a registration certificate for a series (batch) of medical devices.
Or first obtain a registration authorization for a low-risk medical device and then undergo the necessary studies. Next, register the medical device with Roszdravnadzor and obtain an registration certificate of unlimited duration from them.
There are three ways to register medical devices using the accelerated procedure:
These expedited and simplified registration procedures have made it possible to quickly deliver defective medical devices to the market, as well as to curb the skyrocketing prices of medical devices within the condition of economic constraints.
The new Regulations have reduced the period for issuing a registration certificate for a medical device from six months to 5 working days. At the same time, the cost of accelerated registration of medical devices is also quite affordable.
Assistance in Obtaining a Registration Certificate from Roszdravnadzor
It would be easy to assume that the simplified registration of medical devices is straightforward. In fact, it is anything but. There are numerous intricate details and considerations that must be taken into account.
For example, what exactly do you think should be included in the package of documents? If it is necessary to provide instructions for the device, what do instructions for gloves or protective masks look like? Is simplified registration of your medical devices allowed? How to correctly prepare a registration application so that it is not returned for revision? How to obtain a registration certificate for a medical device within 5 days?
The complexity of these questions means that not everyone can provide an immediate answer. Even specialists may require time to respond. If you wish to avoid unnecessary stress and inconvenience when registering medical devices, we advise you to seek the assistance of experienced specialists.
Why should you contact us?
Our company employs a highly skilled team of medical law professionals. Consequently, we are equipped to handle tasks of any complexity. We are proud to report that the percentage of refusals has remained below 0.01 since 2012 according to our company statistics. Furthermore, we have been approached by clients who previously collaborated with other companies and already encountered a refusal to register a medical device. In certain instances, we were able to successfully challenge the refusals and secure positive outcomes for our clients, resulting in the issuance of registration certificates by Roszdravnadzor.
How to start cooperation?
Please advise on the procedure for initiating a business relationship with our MedReg Consulting company. There’s nothing complicated about that. Please contact us via the telephone numbers listed on our website. Our specialists will provide comprehensive consultation on any issue and assist in the establishment of partnership relations.
We will undertake all the work, beginning with the collection of documents and the preparation and submission of an application to Roszdravnadzor in a timely manner. We guarantee the highest quality and completion of all work in the shortest possible time.
The company website contain detailed information about the services we offer, as well as a list of our trusted partners. By cooperating with MedReg Consulting, you will gain a reliable helper to assist you in navigating the complexities of the regulatory landscape.