Accelerated registration of medical devices
Accelerated registration of medical devices
The coronavirus infection has become one of the major impetuses that influence the social life. Regulation of trade of medical devices is not behind the line. The measures taken by the government of the Russian Federation are used first to compensate the increased demand for some categories of medical devices. For this reason, the Government has accepted a scope of documents that accelerate the procedure of state registration of medical devices required in this situation. It allows the manufacturers and the distributors to enter the market as soon as possible.
We consider in details what possibilities the developed measures can give to the market player. The Government has prepared the regulation documents that allow to perform several types of accelerated registration of medical devices:
- registration of a series (a lot) of the medical device according to resolution of the RF Government No.430 dated 03.04.2020;
- registration of the medical devices with low grade of potential risk of use according to resolution of the RF Government No.299 dated 18.03.2020 (resumed since 28.06.2022 and valid till 31.12.2022).
Each type of accelerated registration is characterized by a specified list of medical devices that can be registered according to the given accelerated procedure. We offer you to consider the peculiarities of each type.
Accelerated registration of a series (a lot) of the medical device according to resolution of the RF Government No.430
This type of registration is applicable for the medical devices that are designed for use under the conditions of military actions, emergency situations, prevention of emergency situations, prevention and treatment of diseases that are hazardous for society, illnesses and traumas being a result of harmful chemical, biological, radiation factors. The complete list of the devices with their code designations is given in the table.
The list of medical devices that can be registered as a series (a lot)
| wdt_ID | No. | Type (code of nomenclature classification of medical devices) | Name |
|---|---|---|---|
| 1 | 1 | 169180 | Stationary high-frequency artificial lung ventilation apparatus with electric drive |
| 2 | 2 | 275750 | Anesthetic artificial lung ventilation apparatus |
| 3 | 3 | 311390 | Portable high-frequency artificial lung ventilation apparatus |
| 4 | 4 | 314860 | High-frequency artificial lung ventilation apparatus with pneumatic drive for patients transportation |
| 5 | 5 | 232870 | Artificial lung ventilation apparatus for intense therapy, neonatal/for adults |
| 6 | 6 | 232880 | Neonatal artificial lung ventilation apparatus for intense therapy |
| 7 | 7 | 232890 | General purpose artificial lung ventilation apparatus for intense therapy |
| 8 | 8 | 216540 | Automated pneumatic artificial lung ventilation apparatus for multiple use |
| 9 | 9 | 216260 | Automated pneumatic artificial lung ventilation apparatus for single use* |
| 10 | 10 | 114040 | Portable artificial lung ventilation apparatus with pneumatic drive |
<*> Medical devices for single use.
Documents required for accelerated registration of a series (a lot) of the medical device according to the Government resolution No.430
To get the registration certificate, the Applicant (designer, manufacturer (vendor) of the medical device, authorized representative of manufacturer (vendor) or a person performing importation of the medical device to the Russian Federation to register it) should submit the following to the expert body of the Federal Service for Surveillance in Healthcare (FSBI «National quality institute» of the Federal Service for Surveillance in Healthcare, FSBI «VNIIIMT» of the Federal Service for Surveillance in Healthcare) in electronic and (or) printed form:
| wdt_ID | No. | Name of document(s) | Comment |
|---|---|---|---|
| 1 | 1 | application letter on state registration of the medical device | mandatory |
| 2 | 2 | copy of a document that approves the qualification of a plenipotentiary of the manufacturer | when available |
| 3 | 3 | documents that approve that the series (the lot) of the medical device legally belongs to the applicant | mandatory |
| 4 | 4 | technical documentation of the manufacturer (vendor) for the medical device | when available |
| 5 | 5 | operational documentation of the manufacturer (vendor) for the medical device corresponding to the requirements specified by the Ministry of Healthcare of the Russian Federation | mandatory |
| 6 | 6 | photographic images of general view of the medical device including the accessories required for intended use of this medical device (size of the image should be not less than 18x24 cm) | mandatory |
| 7 | 7 | documents that confirm the results of technical trials of the medical device, toxicology research of the medical device which use presumes contact with a human body, clinical trials of the medical device performed according to the standard test procedure | When trials (research) have been performed in the Russian Federation according to a procedure different from the standard one, the expert body should estimate significance of the scope of such trials (research) |
| 8 | 8 | other documents that characterize quality, efficiency and safety of the medical device | when available |
| 9 | 9 | register of documents | mandatory |
In case when the specified documents are in a foreign language, they should be submitted with translation to Russian confirmed according to the established order.
Peculiarities of registration of a series (a lot) of the medical device
Despite the accelerated procedure of registration, the medical devices should undergo the following trials and research:
- technical trials;
- toxicology research;
- clinical trials.
These trials (researches) have some specific features as they are performed according to standard procedures. These procedures have been developed by expert bodies of the Federal Service for Surveillance in Healthcare. As a rule, they contain a lesser scope of testing for accelerated undergoing of this stage to force the whole registration procedure.
Formally, trials can be performed according to the standard procedures in any laboratory (center) accredited in the national accreditation system. However, we recommend to perform trials in the laboratory of FSBI «VNIIIMT» of the Federal Service for Surveillance in Healthcare. The standard procedures have been developed considering facilitation of this very laboratory with measuring devices and another equipment.
It is allowed to change the name of the medical device as regards changing of information on its serial number, the number of the series (the lot) in case when other information given in the documents of the registration dossier are not changed. However, it is possible only for the medical devices given in points 1-18 of the List of the devices.
Id est, it is possible only for artificial lungs ventilation apparatuses.
As the scheme shows, in some cases the expert body, according to the results of evaluation of the documents for the medical device can issue a conclusion on impossibility of state registration.
The reasons to make a decision on impossibility of state registration of a series (a lot) of medical devices are the following:
- no evidence of compliance of the medical device with the requirements of the manufacturer (vendor) documentation;
- no evidence of safety of the medical device;
- quality, and (or) efficiency, and (or) safety of the medical device are not confirmed by the received information;
- risk to bring harm to health of citizens and medical personnel as a result of use of the medical device is more significant than efficiency of its use;
- the medical device is not in the list of devices for which the Government resolution No.430 is applicable;
- the documents applied to the application letter for state registration are submitted not in a full amount.
Replacement of registration certificate for a series (a lot) of the medical device issued according to resolution No.430
Resolution of the Government No.1826 dated 13.11.2020 increased the validity period of the registration certificate for a series (a lot) of medical devices for a year: till 01.01.2022. For those who received the registration certificate before the resolution came into force (before 24.11.2020), it was needed to replace the registration certificate within a period up to 01.01.2021. Replacement was performed without undergoing the procedure of state registration according to the following scheme:
Since the 24th of December, 2021, Resolution of the Government dated the 10th of December, 2021, No.2250 «On changes in resolution of the Government of the Russian Federation dated the 3rd of April, 2020, No.430» has established that the registration certificates for a series (a lot) of the medical device issued before this resolution came into force with validity period up to the 1st of January, 2022, should be valid till the 1st of January, 2025, without replacement of the registration certificate!
Importation of medical devices for registration of a series (a lot) of the medical device
For registration of a series (a lot) of medical devices, importation can be performed without formal permission of the Federal Service for Surveillance in Healthcare. You can also not to receive the permission for importation of medical devices with aim for trading. This provision is valid till elimination of hazard of emergency situation and (or) elimination of emergency situation itself.
Importation, trade, transportation, storage, use and disposal (utilization) of the medical devices for single use (they are marked as “*” in the table with the List of devices) are also allowed without the permission of the Federal Service for Surveillance in Healthcare if the given devices are registered according to the established order in the manufacturer country.
However, in this case you need the following:
- within 3 working days since importation of the non-registered medical devices to the Russian Federation, submit information on series (lots) to the Federal Service for Surveillance in Healthcare;
the medical devices for multiple use imported to the Russian Federation and not registered according to this document should be eliminated or removed from the territory of the Russian Federation after the 1st of January, 2025;
- weekly, till the 1st of January, 2025, as regards to the medical devices being not registered or registered according to the Resolution and the Registration rules and specified in points 19–78 of the list, the Applicant should inform the Federal Service for Surveillance in Healthcare, according to the list, on their trade, exportation from the territory of the Russian Federation or disposal.
Terms of trade of a series (a lot) of the medical device
You can unlimitedly sell the series (the lot) of the medical device manufactured and imported to the territory of the Russian Federation with issued registration certificate (i.e. registered before 01.01.2025) until the expiration date of the validity period.
As a result of review of peculiarities of registration of a series (a lot) of the medical device, we should underline that acceleration of the procedure is based on the following:
- reduction of the scope and, as a result, the terms of trials (research) of the device samples;
- acceleration of administrative procedures in the Federal Service for Surveillance in Healthcare and the expert bodies.
Accelerated registration of medical devices with low grade of potential risk of use for which peculiarities of state registration are established according to resolution of the Government of the Russian Federation No.299
This variant is possible for 36 types of medical devices. The full list of the devices with low grade of potential risk of use for which peculiarities of state registration are established is given in the table.
| wdt_ID | No. | Type (code of nomenclature classification of medical devices) | Name |
|---|---|---|---|
| 1 | 1 | 104010 | Isolating suit |
| 2 | 2 | 122540 | Hevea latex inspectional/procedural gloves, non-powdered, non-sterile |
| 3 | 3 | 122560 | Hevea latex inspectional/procedural gloves, powdered |
| 4 | 4 | 129350 | Surgical coat for single use |
| 5 | 5 | 129380 | Surgical coat for multiple use |
| 6 | 6 | 129870 | Isolating coat for multiple use |
| 7 | 7 | 129880 | Isolating coat for single use |
| 8 | 8 | 132380 | Face mask for respiratory ways protection, for multiple use |
| 9 | 9 | 139350 | Polychloroprene inspectional/procedural gloves, non-powdered |
| 10 | 10 | 139360 | Polychloroprene inspectional/procedural gloves, non-powdered |
For better understanding, we made a step-by-step schemes of accelerated procedure of registration of medical devices. Each step is given on a separate scheme.
The first stage includes issuance of a temporary registration certificate that is valid within 150 working days since the date of submitting of the application letter to the Federal Service for Surveillance in Healthcare.
List of the documents to be submitted to the Federal Service for Surveillance in Healthcare for state registration according to resolution No.299 (at the stage of issuance of a temporary registration certificate):
- a copy of the documents that approves the qualification of the authorized representative of the manufacturer (the vendor);
- technical documentation of the manufacturer (the vendor) for the medical device;
- operational documentation of the manufacturer (the vendor) for the medical device, including the instruction of the operation manual for the medical device;
- photographic images of general view of the medical device including the accessories required for intended use of this medical device (size of the image should be not less than 18×24 cm);
- documents register.
In case when the specified documents are in a foreign language, they should be submitted with translation to Russian confirmed according to the established order.
The procedure of confirmation of state registration is described on the following schemes. The second stage includes collecting of evidence of quality, efficiency and safety of the medical device by the Applicant.
At the last stage, the evaluation of the submitted documents is performed and decision on confirmation of state registration should be made.
Reasons for the Federal Service for Surveillance in Healthcare to make the denial decision
- conclusion of the expert body based on the results of evaluation of quality, efficiency and safety of the medical device that prove that quality, and (or) efficiency, and (or) safety of the medical device have not been confirmed by the received information, and (or) the risk to make harm to health of the citizens and the medical personnel as a result of use of the medical device prevails over efficiency of its use, and (or) the medical device does not comply with the requirements of regulations, technical and (or) operational documentation of the manufacturer (the vendor), and (or) there are no evidence of safety of the medical device;
- the fact the registration body has found, according to the results of state control over trade of medical devices, a non-compliance of information on efficiency and safety of the medical device with the information on the medical device given in the application letter for registration and the documents.
Acceleration of the state registration procedure for this type is facilitated by the following:
- quick issuance of the temporary registration certificate;
- acceleration of terms of administrative procedures in the Federal Service for Surveillance in Healthcare and the expert bodies.
If you need an accelerated registration of your medical device, you may rely on us. We will select the most convenient scheme for registration of a medical device for you.
