Medical device registration according to the requirements of the EEU

Manufacturing and circulation of medical devices on the territory of the Eurasian Economic Union (EEU)  demands the procedure of its state registration.

There was established a transitional period up to 31.12.2021. within the frames of which medical device registration is carried out according to the choice of the medical device manufacturer ( his authorized representative) with the compliance of: 

1	Requirements of registration and safety expertise, the EEU medical device quality and efficacy;
2	or withthe compliance of the legislation of the EEU member state.

Medical devices under the registration with the compliance of the legislation of the EEU member state are circulating on the territory of that member state.

Documents confirming the fact of medical devices registration and issued by the authorized body of the member state in the field of health care ( e.g. by ROSZDRAVNADZOR if registration was carried out in Russian Federation), with the compliance of the legislation of the member state are valid up to their  expiration date.

We will carry out the registration, changes in the registration certificate as well as in the documents of registration dossier according to the EEU requirements or the requirements of medical devices registration on the territory of the Russian Federation .

Our company provides an exhaustive list of services in the field of medical devices registration (medical equipment) according to the requirements of the EEU:

1	Medical devices state registration;
2	Technical documentation development according to: The requirements of the Order 11Н of the Ministry of Health of Russia;  The requirements approved by the Eurasian Economic Union Commission dated from 12.02. 2016  N 27;  The recommendations of the Eurasian Economic Union Commission Collegium  №17 dated from 04.09.2017 №17.
3	Organization and conduct of technical, toxicological, clinical tests, as well as test for electromagnetic compatibility and in order to approve the type of the measuring instruments, other works
4	Development of a quality management system by GOST ISO 13485-2017. Obtaining the Certificate of GOST ISO 13485-2017.
5	Registration dossier support in ROSZDRAVNADZOR and in the expert organization
6	Support in introducing changes in medical device registration dossier.
7	Support in obtaining the registration certificate duplicate document
8	Support in obtaining the  license on medical equipment manufacturing.

Basic terms and principles used during medical device registration within the frames of Eurasian Economic Union.

Based on «The Agreement on single principles and requirements for a  medical device circulation (medical products and medical equipment)" «medical devices» are determined as any instruments, apparatus, devices, equipment, materials and other products which are used for medical purposes separately or combined with each other as well as accessories required for intended use of the specified products (including specific software) are intended by the manufacturer for the prevention, diagnosis, treatment of diseases, medical rehabilitation and monitoring of the state of the human body. Medical investigations, restoration, replacement, changes in the anatomical structure or physiological functions of the body, prevention or termination of pregnancy and  functional purpose of which is not realized through pharmacological, genetic or metabolic effects on the human body, but can be supported by drugs.

A document confirming the fact of a medical device registration in the Eurasian Economic Union is an unlimited registration certificate a document of a single form containing a code designation assigned to medical devices during their registration, under which they are entered into the United Register of medical devices registered within the Union and kept unchanged upon application of a medical device within the Union.

The United Register of medical devices registered within the Eurasian Economic Union represents medical devices electronic data base registered and approved to the medical application on the territory of the Union.

Medical device registration and expertise with the compliance of the requirements in EEU are carried out on the grounds of Regulations approved by Council Decision of the Eurasian Economic Union economic commission № 46 dated from 12.02.2016., authorized by the body of a reference state according to the medical device expertise results and the agreement of the expert opinion by the states of recognition.

Reference State – chosen by the applicant the EEU member state an authorized body of which carries out a medical device registration procedure. Such authorized body on the territory of the Russian Federation is ROSZDRAVNADZOR. Thus to pass a medical device registration procedure an applicant choses a reference state and a state of recognition.

An Applicant can be a manufacturer itself residing on the territory of the EEU member state or its authorized representative which has to be a resident of the EEU member state as well.

Manufacturer Authorized Representative – it is a juridical or physical entity registered as an individual entrepreneur and a resident of the member state and authorized with the compliance of the power of attorney of a medical device manufacturer to represent its interests and to bear the responsibility in the field of a medical device circulation within the Union and fulfillment of mandatory requirements for medical devices.

When passing a medical device registration procedure according to the requirements of the EEU it is necessary to understand in which of the EEU member state except reference state you are intending to  realize circulation activities of a registered medical device? State registration within the EEU does not imply knowingly a medical device registration in all the EEU countries at once.

Obtaining state registration certificate within the regulations of the EEU, in case of need obtaining a  permission for a medical device circulation in all the Eurasian Economic Union countries, the expertise on safety and quality of a registered medical device issued in the reference state should be agreed in each authorized body  (expert organization) of the each recognition state.

A State of Recognition– is an EEU member state, an authorized body (expert organization) of which helds a procedure of a reference state agreement expert opinion.

Authorized state bodies and expert organizations in the field of the medical device market of the Eurasian Economic Union:

	Russian Federation	RussianFederation  Ministry of Health
		FederalService for Surveillance in Healthcare (Roszdravnadzor)
	Republic of Belarus	Republic ofBelarus Ministry of Health
		«Health care  expertise and test center »
	Рrepublic of Armenia	Ministry of Health of the Republic of Armenia
		Scientific drugs expertise and medicaltechnologies center after Academician E. Gabrielyan»
	Republic of Kazakhstan	Ministry of Health ofthe Republic of Kazakhstan
		«National drugs and medical devices expertisecenter» Committee of medical and pharmaceutical control of the Ministryof Health of the Republic of Kazakhstan
	Republic of Kyrgyzstan	Ministry of Health ofthe Republic of Kyrgyzstan
		Division for assessment of the quality of medicines and medical devices. Department for assessment of the quality of medicines and medical devices Ministry of Health of the Republic of Kyrgyzstan

Medical devices classification except those for in vitro diagnostics

According to the grounds of «The requirements for the classification of medical devices depending upon the potential risk of use» medical devices  when circulating in the Eurasian Economic Union depending upon the potential risk of application are divided into 4 classes. 

Their definitions are: 1, 2а, 2б и 3. Each single medical device can be referred to only one class. It takes place as it is shown below:

Class 1	medical devices of low degree of potential risk of  use;
Class 2а	medical devices of medium degree of potential risk of  use;
Class 2б	medical devices of increased degree of potential risk of  use;
Class 3	medical devices of high degree of potential risk of  use.

Medical devices classification for in vitro diagnostics

Medical devices for in vitro diagnostics – any instruments, apparatus, devices, equipment, materials, reagents, calibrators, testing materials and other items used in medical purposes separately and combined with each other and with the accessories for application of the named devices by appointment as well (including specific software), and determined by the manufacturer for application when testing  in vitro of samples of human biological materials for obtaining the information concerning physiological and pathological condition, genetic pathology, predisposition to a specific clinical condition or disease, tissue compatibility with a potential recipient, predicting responses to theraupeutic agents and (or) monitoring treatment.

According to the grounds of «The requirements for the classification of medical devices depending upon the potential risk of use» medical devices for in vitro diagnostics  when circulating in the Eurasian Economic Union depending upon the potential risk of application are divided into 4 classes .

 Their definitions are: 1, 2а, 2б и 3. Each single medical device for in vitro diagnostics  can be referred to only one class. It takes place as it is shown below :

Class 1	medical devices for in vitro diagnostics of low degree of potential risk of  use for an individual person and  low degree of potential risk of  use for social health
Class 2а	medical devices for in vitro diagnostics of medium degree of potential risk of  use for an individual person and  low degree of potential risk of  use for social health;
Class 2б	medical devices for in vitro diagnostics of high degree of potential risk of  use for an individual person and  medium degree of potential risk of  use for social health;
Class 3	medical devices for in vitro diagnostics of high degree of potential risk of  use for an individual person and  high degree of potential risk of  use for social health.

Medical devices modification upon registration according to the requirements of the EEU. Medical devices nomenclature classifier of the EEU.

Medical device modification –  a type of medical device that has in common with the main medical device design features developed on the basis of the main device with the aim of improving it, expanding or specializing the use for medical purposes.

Depending upon the type of a medical device included into a nomenclature of medical devices of the Union, it is defined a possibility of including in one and the same registration certificate several modifications of a medical device referring to one type of medical device.

Criteria for including the type of a medical device in the same registration certificate several modifications of a medical device referring to one type of medical device with the compliance of applied in the Eurasian Economic Union  a nomenclature of medical devices are the subject to be  defined by the Eurasian Economic Union Commission on economic issues.

Medical devices registration process stages according to the requirements of the EEU.

Medical devices registration procedure according to the requirements of the Eurasian Economic Union covers two stages:

1  STAGE	1	Determination of the type of the risk of use and nomenclature type (it is also determining the possibility of including into one and the same registration certificate several modifications of a medical device referred to one type of a medical device ).
	2	Determination the list of documents depending upon the class of potential risk of using medical device.
	3	Safety and efficacy proofs collection. Introducing: technical tests, tests (investigations) aiming to evaluate the biological impact of a medical device ; testing to approve the type of measuring instruments; clinical tests (investigations)).
	4	Reference and recognition state selection.
Payment of state duty	1	After the registration dossier is finalized an applicant pays the state duty for expertise and registration procedures of a medical device in reference state.
	2	State duty for expertise and registration procedures of a medical device in the states of recognition is being held after the acceptance of a positive decision on a medical device registration by reference state. The amount and procedure of payment is determined in accordance with the legislation of member states.
2 STAGE	1	Documents to represent	Expertise  application form
			Medical device expertise application form
			Registration dossier
			Copies of the documents confirming the payment of medical device for expertise and registration procedure in reference state
	2	Medical device expertise
	3	Coordination of  expert opinion  by the states of recognition
	4	Medical device registration

Medical devices testing process within the frames of medical devices registration procedure according to the requirements of the EEU.

Within the frames of a medical device registration according to the requirements of the EEU  the following tests should be held: 

1	Technical tests ( concerning medical devices for in vitro diagnostics (reagents, reagent kits) technical testing is not carried out);
2	Tests (investigations) aiming to evaluate medical devices biological impact (testing is carried out concerning medical devices and (or) accessories to medical devices interacting with a surface area of a human body, its mucous membranes, internal environments of a body);
3	Tests for the approval of the type of measuring instruments;
4	Clinical tests (investigations).

Testing could be carried out in chosen by the applicant authorized institutions and organizations having the right to proceed them and aimed to assist in medical devices registration procedure and included into the united register of authorized organizations of the Union.

When holding clinical testing (investigations) an applicant can provide a medical device to the chosen authorized organization or to include into the registration dossier already prepared clinical data.

During the registration and expertise of  medical devices authorized bodies  mutually recognize the results of technical tests and investigations, investigations (tests)  aiming to evaluate medical devices biological impacts, clinical testing, tests for the approval of the type of measuring instruments (concerning medical devices associated to the measuring instruments in the field of state regulatory affairs ensuring the uniformity of measurements the listing of which is approved  by the Commission) under the conditions that they are carried out with the compliance to the requirements and the requirements established by the Commission.

The quantity of medical devices investigations (tests) intending to their further registration depends upon the type of medical devices: non-active, active, active diagnostic, implantable medical devices, medical devices for in vitro diagnostics.

When holding investigations (tests)  of medical devices intending to their further registration can be applied standards introduced into the listing of standards as a result of the use of which , on a voluntary basis, the compliance of a medical device with the general requirements is fully or partially ensured and manufacturer’s medical device technical documentation as well.

In case of standards absence introduced into the listing of standards aiming to carry out medical device technical tests can be  applied testing methods  (methodologies)  certified (validated)  and confirmed with the compliance to the legislation of the Union member states.

Validation – approval by means of objective evidence, that requirements are fulfilled for a particular use or application.

Authorized organizations representatives which carried out technical tests, investigations  (tests) aiming to evaluate biological impact and medical device clinical testing represented for expertise cannot be invited for participation in registration dossier expertise within a medical device registration process in the authorized state body (expert organization).

Medical devices manufacturing inspection within the frames of medical devices registration procedure according to the requirements of the EEU.

Within the frames of medical devices registration procedure according to the requirements of the EEU  production inspection is carried out,  assessment of production conditions and the manufacturer quality management system for the compliance to the Requirements established by the EEU economic commission Council Decision dated from  10 ноября 2017  N 106.

Medical devices quality management system should comply to the Requirements and maintained in actual condition.

An authorized body (expert organization) or organization determined as the authorized body,  (expert organization) of reference state carries out medical devices inspection  before expert opinion  within the frames of a medical device registration according to the  EEU requirements.

Medical devices registration certificates terms of receipt according to the requirements of the EEU:

The term of obtaining of registration certificate depends upon many factors: medical device class of risk, required scope of tests, quantity of the states of recognition.

Due to the fact that a procedure of a medical devices registration according to the EEU requirements consists of a big number of stages comparing with the registration only by according to the Russian Federation requirements, terms of registration according to the EEU  requirements are covering  bigger terms comparing with the registration only by  according to the legislation of the Eurasian Economic Union member state.

For instance the term of a medical device registration in case of presence of violations can last up to 13 months, and in the absence of such – up to 9 months. 

From the date of a  receipt of the application form and registration dossier to the authorized body (expert organization) the terms of the documents consideration are as follows:

Stages	procedures	terms
1 stage	Checking the completeness and reliability of the information contained in the application form and in  the registration dossier	during 5 working days  a decision is held regarding the beginning of a medical device expertise and registration procedures
2 stage	In case if application form is submitted with requirements violation, in application form is indicated incorrect information or registration dossier is not presented fully then a notification of elimination of violations is sent to the applicant	during 5 working days from the day of application form and registration dossier acceptance
Elimination of identified violations and (or) submission of missing documents		30 working days
3 stage	If an application form and registration dossier are corresponding to the requirements	During 3 working days by the authorized body (expert organization) of reference state arrives at a decision to start expertise procedure and medical device dossier registration.
Authorized bodies (expert organizations) of recognition states have the right to familiarize themselves with the progress of expert work in the reference state including with the correspondence between the applicant and the authorized body (expert organization) on the elimination of comments and with the documents submitted by the applicant in the process of examination and registration of medical devices.
4 stage	Medical device expertise procedure and expert opinion is carried out by authorized body (expert organization) of reference state	Within the terms not exceeding 60 working days from the date of decision to start a  medical device  registration and expertise procedure
5 stage	Incase if expertise  is confirmed to be positive, authorized body of a reference state notifies the applicant  to proceed with the payments for expertise and registration in the sates of recognition	Within 5 working days from the date of expert opinion paperwork
6 stage	Applicant’s payment copies  submission procedure concerning expertise and registration in the states of recognition	Within 10 working days from the date of notification acceptance
7 stage	Authorized body (expert organization) or organization determined by the authorized body (expert organization) of reference state carries out medical devices manufacturing inspection in accordance with the requirements established by the Commission. Medical devices manufacturing inspection is carried out before  expert opinion, i.е.the expertise of registration dossier.	The term of organization and carrying out the inspection does not include  in the total term of expertise procedure  and cannot exceed 90 working days period in total
If in case of medical device expertise procedure for the expert opinion preparation is lack of some materials or information contained in the registration application form and in the documents of a registration dossier, authorized body (expert organization) sends to the applicant an appropriate request with an indication of the nature of the comments and the way to eliminate them. The period from the day of the request is sent to the day the authorized  body (expert organization) receives a response from the applicant to the request is not taken  into account when calculating the period fora medical device expertise.		The applicant should feedback within 60 working days from the date of the received request. In case if a feedback was not provided at the specified time      an authorized body (expert organization) arrives at a decision on the grounds of documents available to him.
After the expert opinion registration an authorized body (expert organization) of a reference state places it  into its data system
8 stage	Authorized bodies (expert organization) of the recognition states direct to the authorized body (expert organization) of reference state the expert opinion confirmation of agreement (or non-agreement).	Within 30 working days   from the date of placing the data by the authorized body (expert organization) of the  expert opinion reference state
In case of failure of the states of recognition to submit the confirmation of the agreement (non-agreement)  of the expert opinion within 30 working days from the date of the expert opinion placement by the authorized body (expert organization) of a reference state the expert opinion is considered to be  agreed.
9 stage	The authorized body of a reference state arrives at a decision of a medical device registration and introduces into the united register of medical devices registered in the Union information regarding medical device, user’s manual (medical device application instruction) image of approved medical device labeling.	During 10 working days from  the date of the expert opinion approval by the states of recognition
10 stage	The authorized body of a reference state  draws up a registration certificate and annex to it, or notifies the applicant about the refusal to register a medical device During 10 working days from  the date of the  decision about medical device registration	During 10 working days from  the date of the  decision about medical device registration
As a result in case of  violations absence  the term of receiving registration certificate makes:		≈216 working days
As a result  in case of presence and elimination of violations the term of receving registration certificate makes:		≈300 working days

The grounds for the issuance by the authorized body (expert organization) of a conclusion on the refusal to register a medical device are:

1	Failure to confirm with the relevant materials and information contained in the registration dossier, quality, and (or) efficacy, and (or) safety of a medical device;
2	Excess of the risk of harm to the health of citizens and medical workers due to the use of a medical device over the effectiveness of its use;
3	Non-elimination of detected violations and (or) non-submission of documents upon request

Medical devices registration list according to the requirements of the Eurasian Economic Union:

For medical device registration procedure an applicant choses a referent state and a state of recognition. The following listof the documents should be provided:

1	Application form for expertise	originals
	Application form for a medical device registration
2	Power of attorney from the manufacturer having the right  to represent interests during registration procedure - ( if necessary)	In accordance with the international certification standards or certification standards established according to the legislation of the member state of the Eurasian Economic Union (further – member state)
3	A copy of the authorization document  for the right to manufacture in the country of origin (if any)	A copy of the authorization document  for the right to manufacture in the country of origin (if any)
4	Medical device manufacturers certificates copies for the qualitymanagement system (ISО 13485 or appropriate regional or national standard of a  member-state)- (if any)	In accordance with the international  certification standards or certification standards according to the legislation of the member sate
5	Declaration of conformity to the general requirements of a medical device safety and efficacy or equivalent document (if any)
6	Registration certificate copy (free sale certificate, export certificate (except medical devices for the first time manufactured on the territory of the member-state)), issued in the country of origin (if any)  including Russian  translation	In accordance with the international  certification standards or certification standards according to the legislation of the member sate
7	Copy of the document certifying the registration in other countries (if any)	Certified by the manufacturer (his authorized representative)
8	Medical device reference describing  the area of application and purpose, medical device short  specification, performing variants and accessories (in shape)	Certified by the manufacturer (his authorized representative)
9	Labeling and packaging data (full-color layouts of packages and labels, marking text in Russian and state languages of the member states)	Certified by the manufacturer (his authorized representative)
10	Designing and manufacturing information: production process schemes, main production stages, packaging, testing and final product output procedure	Certified by the manufacturer (his authorized representative)
11	Manufacturer information:  name,  type of business activity, juridical address, type of the ownership, managerial staff, the list of departments and affiliated companies indicating their status and full powers	Certified by the manufacturer (his authorized representative)
12	Marketing information  (with condition of product’s background circulation on the market more than 2 years) (if any) - (except for the 1st and 2nd A class)	Certified by the manufacturer (his authorized representative)
13	Accidents and reference reports ( this information is not supplied for the new developed and designed medical devices): The list of undesirable events and accidents associated with the use of the device and an indication of the period of time during which these accidents occurred, If the listing of undesirable events exceeds then it is necessary to represent short reviews on each of the type of the events and to indicate total number of each type of the reported  events, reference lists from the medical device market and  (or) explanatory letters and approach description for the problems analyses and their  manufacturer decisions in each of the named above cases, Reviews description and (or) improving activities taken as the appropriate reaction, - (except for the 1st class )	Certified by the manufacturer (his authorized representative)
14	The list of standards of a corresponding medical device (indicating information about them)	Certified by the manufacturer (his authorized representative)
15	Medical device compliance information to the general safety requirements and their efficacy, labeling requirements and operational documentation for them (further – general requirements)	Certified by the manufacturer (his authorized representative)
16	A document establishing requirements for the technical characteristics of a medical device	A document establishing requirements for the technical characteristics of a medical device
17	Technical testing protocols held aiming to prove the general requirements compliance (excluding reagents and reagent kits )
18	Examining protocols ( tests ) on the medical device biological effect assessment, carried out in order to prove compliance with the general requirements
19	Medical device clinical efficacy proof and safety report (except for the1st class)	Certified by the manufacturer (his authorized representative)
20	Risks analyses report - (except for the 1st class)	(except for the 1st class)
21	Data on medical products as a part of a medical device (medical product composition, quantity, data on the medical products compatibility with a medical device,  medical product registration procedure in the country of the manufacturer)	Certified by the manufacturer (his authorized representative)
22	Biological safety data (if any)	Certified by the manufacturer (his authorized representative)
23	Data on the sterilization procedure, including information on validation process, test results for the content of microorganisms (bioburden degree), pyrogenicity, sterility (if necessary) with an indication of the test methods and packaging validation data (for sterile products - (except for the 1st class	Certified by the manufacturer (his authorized representative)
24	Special software data  (if any): manufacturer software validation data	Certified by the manufacturer (his authorized representative)
25	Stability testing report –  with an authentic Russian translation of the device testing  results and conclusions with a shelf life included	Certified by the manufacturer (his authorized representative)
26	Medical device operational application or instruction  in the state language of the states of recognition (if necessary) and Russian translation included	Certified by the manufacturer (his authorized representative)
27	Service manual (in terms of a medical device components) – in case of  operational documentation data absence (if any)	Certified by the manufacturer (his authorized representative)
28	Production inspection report  ( if any)
	Collecting and data analyzing plan of medical devices   safety and efficacy at the post-sale stage	Certified by the manufacturer (his authorized representative)
29	Documents confirming medical devices testing in order to  approve the type of measuring instruments (regarding medical devices related to measuring instruments the list of which is approved by  the Commission (if necessary)
30	Copies of the documents confirming the payment and expertise  results, medical device registration in a reference sate

Medical devices state duty for registration and expertise intended for circulation on the common market according to the requirements of the EEU:

For a medical device registration certificate receipt	7 000 roubles
issue of a medical device registration certificate duplicate	1 500 roubles
To insert the documents contained in a medical device registration  dossier, refinements, not requiring expertise of safety ,quality and efficacy of a medical device	1 500 roubles
For holding of safety expertise, quality and efficacy of a medical device (depending on the class of potential risk of its use) during the registration:	Class 1 - 45 000 roubles; Class 2а - 65 000 roubles; Class 2b - 85 000 roubles; Class 3 - 115 000 roubles;
For holding of safety expertise, quality and efficacy of a medical device (depending on the class of potential risk of its use)  when making changes to the documents contained in the registration dossier of a medical device:	Class 1 - 20 000 roubles; Class 2а - 30 000 roubles; Class 2b - 40 000 roubles; Class 3 - 55 000 roubles;
For agreeing an expert opinion on the assessment of safety, efficacy and quality of a medical device  when making its registration( depending on the class of potential risk of its use)	Classс 1 - 45 000 roubles; Class 2а - 65 000 roubles; Classс 2b - 85 000 roubles; Classс 3 - 115 000 roubles;
For agreeing an expert opinion on the assessment of safety, efficacy and quality of a medical device when making changes to the documents contained in the registration dossier of a medical device:  (depending on the class of potential risk of its use):	Class 1 - 20 000 roubles; Class 2а - 30 000 roubles; Class 2b - 40 000 roubles; Class 3 - 55 000 roubles.
All medical devices registration and expertise expenses are borne by the applicant in accordance with the legislation of the member state of the Union..

Medical devices manufacturing in the Eurasian Economic Union

The manufacturer of medical devices designed for the circulation in the Union ensures the implementation and maintenance of a quality management system for medical devices.

The manufacturer is obliged to create and maintain up to date systems for collecting an analyzing data on the use of medical devices, as well as to monitor and identify side effects of those during operation .

If you start with zero point?

We will provide all necessary customer services willing to start their activities on obtaining medical device registration certificate within the frames of the  EEU from “zero point “mode:

1 step	We will provide juridical entity or individual enterprise registration
2 step	We will help to open a current account
3 step	We will help you to find an appropriate room
4 step	We will help you to purchase or  rent the equipment
5 step	We will find staff and provide their training
6 step	We will develop the system of quality manegement by GOST ISO 13485-2017. We will obtain the Certificate of  GOST ISO 13485-2017.
7 step	We will organize all the types of test passing
8 step	We will develop technical documentation
9 step	We will obtain medical devices registration certificate according to the rules of EEU
10 step	We will obtain the license for medical equipment manufacturing

Apply for a registration certificate according to the requirements of the EEU using the service order application form:

Use a call order, contact and e-mail us. We look forward to collaborate with you.