Being a part of medical devices registration according to the requirements of the Eurasian Economic Union production inspection is carried out, production conditions and quality management system of a medical device manufacturer are assessed for compliance with the requirements established by the decision of the Council of the Eurasian Economic Commission dated from November 10, 2017, N 106.
Medical devices quality management system should correspond to the Requirements and maintained in actual conditions.
Our company is ready to develop and implement a quality management system for the manufactures being in the residential status of the Russian Federation aiming to introduce the procedure of a medical device registration with the compliance of the Eurasian Economic Union requirements.
Medical device quality management system should ensure compliance of produced and put into the circulation medical devices within the Union applied to the General safety and efficacy requirements approved by the decision of the Council of the Eurasian Economic Commission dated February 12, 2016, N 27 .
Actually it is a point of a medical device manufacturer compliance to the interstate Eurasian Union GOST ISO 13485-2017 standard "Medical devices. Quality management systems. System requirements for regulatory purposes". indicated GOST is identified to the standard ISO 13485-2016. However a certificate itself within production inspection GOST ISO 13485-2017 is not issued.
| Quality management system | |
| No need to implement |
Need to implement |
| Medical devices manufacturers of a risk class 1 and non-sterile medical devices of a class risk 2а (but has the right to implement and to maintain the system) | Medical device producing production companies of 2а (only sterile), 2b, 3of a potential use risk classes |
System should be implemented before a medical device registration documents submittance to an appropriate authorized body.
Roszdravnadzor, being an authorized organization within the EEU can obtain the rights of an inspecting organization and to empower the right for production inspection to an appropriate organization (or organization) as well
At present moment in the Russian Federation such an inspecting organization is the All-Russia Scientific-Reseach Institute of Medical Equipment and it could be possible in the future that The National Quality Institute could gain this competence as well
An inspecting organization in case of need has the right to introduce outsource experts for exercising of its direct authorities .
All the expenses concerning production inspection procedure within the quality management system of a medical device are the subject to borne by a medical device manufacturer according to the agreement signed with inspecting organization.
With the compliance of the Ministry of Health Regulation dated from 21.07.2020 N 726н a methodology for determining the amount of payment for assessing production conditions and quality management system was approved and the maximum amount of fees for the provision of services was set as well.
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The maximum amount of fees for the provision of a service including travel expenses with VAT of 20% (inside the RF territory) |
The maximum amount of fees for the provision of a service including travel expenses with VAT of 20% (outside the RF territory) |
| 1 673 253,91 руб. | 2 417 845,63 руб. |
Together with quality management system the inspecting organization carries out the control of production conditions which are consisting of as follows: infrastructure and environmental conditions necessary for providing necessary compliance of manufactured medical devices to the General requirements of efficacy and safety.
| 1 | To obtain a certificate ISO 13485-2017 (or equivalent document to the mentioned international standard)* |
| 2 | To implement an appropriate medical devices quality management system directly in production * |
| 3 | To submit audit reports of Quality Management System (QMS) (if any)* |
| 4 | To produce medical devices of risk class 1 and non-sterile medical devices of risk class 2а and not to implement QMS |
| 5 | To produce medical devices of risk class 2а (for sterile medical devices) and 2b. You can make savings here due to the absence of the necessity to implement medical devices development processes and designing |
| *In the presence of these documents you can save as well on medical devices quality management system functioning by the inspecting organization, particularly on evaluating the document and records management process (in terms of after-sales monitoring) | |
In case if certificate ISO 13485/ is obtained, its implementation within a quality management system, inspection in terms of after-sales monitoring, is limited to verification of the requirements associated to the processes:
| 1 | Medical devices designing |
| 2 | Medical devices developments |
| 3 | Production and medical devices output inspection |
| 4 | Associated with a consumer (in terms of after-sales monitoring). |
We will provide services on certificate ISO 13485 obtaining, development and assistance to implement quality management system according to ISO 13485 standards to medical devices manufacturers residing in the Russian Federation as for primary periodical (scheduled) so for the unscheduled form of inspection control.
Please use the service order form:
For the initial evaluation form it is necessary to develop and implement medical device quality management systemт comprising all the mentioned in the Requirements processes. Suсh as:
| 1 | Development and designing processes if they are included into medical device manufacturer quality management control system; |
| 2 | Records and documentation management processes; |
| 3 |
Production and medical devices output inspection; |
| 4 | Corrective and preventive actions processes; |
| 5 | A ssociated with a consumer processes. |
Medical devices manufacturers of risk class 2а (for medical devices produced in sterile form) and 2b before submitting the documents for a medical device registration should implement a quality management system (except processes of designing and development).
Medical devices manufacturers of risk class 3 should implement a medical device quality management system comprising all the mentioned above in the table processes.
There are established 3 forms of a quality management system:
| 1 | Initial | It is carried out with a medical device registration procedure within the frames of the Union. Finally the report is valid for 3 running. |
| 2 | Periodical (scheduled) | It is carried out once per 3 years after registration procedure |
| 3 | Unscheduled | It is carried out in case of introducing changes into the documents, elimination of violations, poor quality products manufacturing and elimination of the causes that led to a poor product output, implementation of a new QMS |
Based on the paragraphs 23 of the Decision №46 dated from 12.02.2016 medical devices manufacturing inspection is carried out within the frames of started medical devices registration procedure and up to the expert opinion preparation. Term of inspection does not cover general term of expertise procedure and cannot exceed more than 90 working days
Initial evaluation is carried out by the inspecting organization of the member state country an authorized body of which proceeds a medical device registration.
Based on the paragraphs 18 of the Decision №106 dated from 10.11.2017 № 106 an authorized body in the term of not exceeding 3 months from the date of full set of the documents of a medical device manufacturer is submitted including production inspection payments, determines inspecting organizations for production inspection procedure according to medical device manufacturers official request and (or) in compliance with production inspection schedules.
Basing on the all forms of evaluations manufacturer receives a report on production inspection results. This document is directed by the inspecting organization to an authorized body to be put in the registration dossier by postal registered mail with an acknowledgement of receipt or in the form of electronic document with an electronic signature in terms of 15 working days from the date of finalizing the inspection production.
The QMS initial evaluation report of medical devices is valid in terms of 3 years from the date of issue.
By periodical (scheduled) evaluation a medical device manufacturer has the right to apply to any inspecting organization, the EEU member states, carrying out medical devices production QMS procedure with a notification regarding periodical (scheduled) production inspection in terms of 6 months before the expiration date of the report concerning results of former production inspection procedure submitting an appropriate documentation proof .
Inconsistencies revealed according to the results of production inspection are the subject to be eliminated by a medical device manufacturer during the inspection procedure itself or in terms not exceeding more than 30 working days from the date of finalizing production inspection.
In case of a manufacturer negative decision disagreement or inconsistencies revealed he is eligible to file a claim to the inspecting organization in terms of 30 working days from the date of an inspecting organization report copy receiving on the results of production inspection.
If no agreement is reached than a medical device manufacturer is eligible to file a claim to a court by the inspecting organization residence address or to an authorized body authorizing the organization to carry out medical device QMS evaluation procedure.
In case if a medical device manufacturer does not eliminate or violates the terms of fixing the problems than the inspecting organization informs an authorized body authorizing the organization to carry out medical device QMS evaluation procedure about it.
Before fixing the problems by a medical device manufacturer indicated in the inspection production report an authorized body has the right to suspend a medical device manufacturer production in the territory of the member sate with the compliance of mentioned above state legislation. In this case an authorized body informs the authorized bodies of other member states on the fact of a medical device production suspension in the territory of the member states applying the options of the Union integrated data system.
Medical devices manufacturers of potential risk class use 1 and non-sterile medical devices manufacturers of potential risk class 2а are having an option not to implement and maintain the QMS of medical devices but are having the right to do so as well.
In this case if the mentioned manufacturer passes through the QMS evaluation procedure of a medical device including processes of development and design with the compliance to the Requirements, than during the terms of conclusion (covering 3 years), contained in the production inspection results report, introducing changes into registration dossier of such medical devices are the subject to carry out without safety, quality and efficacy expertise procedure only by means of a notification order.
| 1 | Medical devices technical characteristics requirements description, standards or separate sections (clauses and subclauses) of the applied standards and if in case these appropriate standards will not be applied, the methods used to ensure the General safety and efficacy requirements applied to the produced medical devices will be followed; |
| 2 | Description of methods and approaches of the inspection of the third party if development, production and (or ) output control are carried out by the third party; |
| 3 | Production processes description, quality control and medical device quality assurance, processes and systematic measures used implemented for Q.C. and medical device quality assurance, corrective and preventive activities as well ; |
| 4 |
Medical device accounting for quality indicators documents description (internal inspection reports, inspections, concerning testing results and other documents); |
| 5 | Quality means of description aiming to reach a medical device appropriate quality and medical device quality system effective functioning; |
| 6 | Description of plans, procedures and consumers feedback documents (medical device safety and efficacy monitoring on after-sale stage as well). |
| 1 | To develop documented requirements of risks management in all the stages of medical device life cycle; |
| 2 |
To identify processes necessary to effective medical device quality management system functioning, (further - processes), and application of processes in organization – medical devices manufacturer; |
| 3 | To identify sequence and interconnection of the processes; |
| 4 | To identify criteria and methods necessary to ensure the effectiveness as when carrying out the processes so when managing them; |
| 5 | To provide production conditions, resources and information necessary to maintain the processes and monitoring implementation; |
| 6 | To carry out monitoring, measurement (where it could be applied) and processes analyses; |
| 7 | To take measures necessary for achieving our planned results and to support process effectiveness . |
We are ready to develop a medical device quality management system and to obtain the certificate by GOST ISO 13485-2017.
In case if you want to get more detailed additional information, consultation we will be glad to render you any assistance and support.
