Three Things You Should Know About Medical Device Regulations in the Eurasian Union, September 2019

 

 Dear colleagues:

This is my monthly selection of updates on medical device regulations in the Eurasian region:

  1. Changes to the Eurasian Transition Period for Medical Devices

Here is the long-awaited update on the Eurasian transition period for medical devices. On 5 September 2019, the Eurasian Economic Commission published Decision no. 142 (link in Russian) which contained an approved draft of the proposed changes to a transition period for registration for medical devices. According to this document, if a medical device is approved in a Eurasian member state before 31 December 2021, it may be re-registered <only in this member state> using the local re-registration procedure until 31 December 2026. Such a device can be on sale in this member state <but not the whole Eurasian Union> until the expiry of the registration certificate.

Previously, the Eurasian Agreement on medical devices required re-registration of all medical devices using the Eurasian registration procedure before 31 December 2021. In the last two years, several proposals from Eurasian member states to change these transition deadlines have been discussed.

Registrations of new medical devices before 31 December 2021, can be submitted using either the local registration procedure or the Eurasian registration procedure. After 31 December 2021, all new medical devices should be submitted for registration using the harmonised Eurasian procedure only.

The Eurasian member states must first ratify (within 90 days) the draft of Decision no. 142 (link in Russian) before this comes into effect.

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While the Ministry of Health of Kazakhstan recently reported the first Eurasian approval of a pharmaceutical product,  activity on Eurasian medical device registration is still not too fast: for today there is still minimal information about products submitted for registration. Twenty-five laboratories are accredited to perform registration type testing. However, there is still no clarity as to when the quality management system (QMS) inspection, which is required for registration may begin.

  1. Draft Guidance to Determine the Costs of QMS Inspection in the Eurasian Union

On 2 September 2019, the Russian Ministry of Health published a draft policy for determining the fees for a QMS inspection before registration of the medical device can take place within the Eurasian Union (link to the document in Russian).

According to Regulation no. 106, which came into force in March 2018, the QMS inspection of manufacturing sites is mandatory for the registration of most IIA-III class medical devices in the Eurasian Union. The scope of the QMS inspection includes the assessment of quality sub-systems, i.e. design and development, document and record management, production and output control, corrective and preventive actions, and consumer-related processes.

The document proposes rules for calculating the cost of an inspection which depends on the number of employees of the enterprise and its location. The document also suggests the duration of the inspection is from four to eleven working days, and that the maximum cost is limited to 2,600,000 RUB (approx. 40,000 USD), excluding the cost of translation services.

  1. New Rules for Technical Testing of Medical Devices in Kazakhstan

On 6 September 2019, the Ministry of Health of Kazakhstan released Regulation KR DSM-124 (link in Russian) regarding technical trials for medical devices as part of the national registration procedure. According to the document, technical tests of medical devices (not required for in-vitro diagnostics) are carried out as type testing of samples or as data analysis (e.g. for some large-sized medical devices). These tests include assessment of the parameters provided in the technical or operational documentation, evaluation of the ‘design and operability of a medical device in terms of safety, ease of use, operational and ergonomic characteristics’, and an assessment of the labelling and packaging of a medical device. The duration of technical testing, according to the rules, should not exceed 30 calendar days.

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I would like to thank LIMI Consulting who helped me prepare the update regarding the Kazakhstan regulation in this post.

Three Things You Should Know About Medical Device Regulations in Russia and CIS, March 2018

 


Dear colleagues,

Welcome to my monthly newsletter with updates on medical devices legislation in Russia and the Eurasian Union for March 2018.

  1. Eurasian Quality Management System Requirements for Medical Device Manufacturers

On 15 March 2018, Regulation #106 of the Eurasian Commission on the requirements on the quality management system (QMS) for manufacturers of medical devices for the Eurasian Economic Union (EAEU) registration procedure (link in Russian) came into effect.

The published regulation describes requirements to the QMS for medical device manufacturers and requires mandatory scheduled and unscheduled audits of manufacturing sites to demonstrate compliance with these requirements within the EAEU registration process.

The Eurasian Commission notes that, despite the fact that the requirements were developed on the basis of the international standard ISO 13485, the audits will be based on compliance with the requirements of the EAEU QMS regulation but not with requirements of the ISO standard itself.

At the same time, during the transition period until 15 March 2019, the regulation allows the registration in the EAEU of certain classes of products providing certificate ISO 13485 as evidence of an implemented QMS system, but in this case the manufacturers will have to pass an unscheduled inspection of the manufacturing site within two years from the date of registration.

Summary of EAEU medical device regulations for the end of March 2018:

 

  1. Potential Special Registration Route for Certain Medical Devices Manufactured in Russia

In mid-March 2018, the Russian Ministry of Health published a draft (link in Russian) amendment to article 38 of the Federal Law 323 that introduces a special registration route for certain low-risk medical devices manufactured in the Russian Federation.
The amendments will affect medical devices manufactured by Russian manufacturer, intended for use by medical personnel only and included in the list of “high-tech and innovative products”. The published document also establishes special requirements for post-registration safety monitoring for such products. It should be noted that Russian legislation today does not contain the above-mentioned criteria for “high-tech and innovative” products. It is expected that the amendments will come into force on 1 January 2020.

 

  1. New Medical Device Registration Rules in Uzbekistan

On 23 March 2018, the government of Uzbekistan published resolution #213 (link in Russian) with amendments to the registration rules for medicines and medical devices in the country. The resolution establishes the requirements for documents, samples, and fees for registration of medical devices in Uzbekistan and sets timelines for this procedure as 120–150 days. The approval process may also require clinical trials and manufacturing site inspection. The resolution establishes the validity of the registration license for a medical device as five years and contains a list of devices that do not require registration.

Three Things You Should Know about Medical Device Regulations in the Eurasian Union, October 2017

 

Dear colleagues and group members,

In October 2017 my usual newsletter will focus on updates in developing harmonised Eurasian medical device regulatory system.

 

  1. Eurasian Quality Management System Requirements for Medical Device Manufacturers

In early October 2017, the Eurasian Commission published decision 134 (link in Russian), which includes what is requirements for a quality management system (QMS) for manufacturers of medical devices.
This decision is the last of the “second level” documents approved in the harmonised Eurasian model.

According to the published regulation, the implementation, development and maintenance of the QMS is becoming mandatory for the registration of  sterile IIA, IIB, III class devices. For low class devices (I and non-sterile IIA class products) QMS maintenance is not formally mandatory,however, it offers the advantage of a simplified amendment/re-registration procedure (notification instead of assessment).

The document contains checklists with requirements for every QMS subsystem: design and development controls, record/document change control, corrective and preventive actions, production and process control and consumer-related processes.

The assessment of the QMS is a mandatory step in the registration process and is carried out by way of an inspection audit of every declared manufacturing site by accredited organisations of Eurasian member states (according to the document, there is a list of accredited organisations maintained by the regulator of each member state, and the manufacturer may apply to any of them).

In addition to the primary “registration” inspection audit periodic post-registration QMS assessment inspections are also requited once every three years, as well as unscheduled inspections in limited cases.

The document introduces a twelve-month transitional period, during which QMS assessment is not mandatory for the registration. During this period, the submission of an ISO 13485 certificate provides a presumption of conformity with quality requirements when the QMS inspection audit is postponed (within a two-year period after registration).

 

  1. Russian Laboratories are Preparing to Start Medical Device Testing According to Harmonised Eurasian Requirements

In early October 2017, the Russian medical device expert centre (VNIIMT (ВНИИМТ) published information about its inclusion in the list of organisations accredited for technical and biological testing for the registration of medical devices according to the Eurasian procedure.

Later, on 27 October, during the seminar on Eurasian medical device testing requirements held by the same organisation, it was confirmed that manufacturers may apply for start testing according to the new requirements.

At the end of October 2017, there are two laboratories accredited for testing according to Eurasian requirements. The list is published on the website of the Russian medical device regulator Roszdravnadzor.

It should be noted that the Eurasian medical device regulation model contains separate requirements for technical (link in Russian) and biological safety (link in Russian) testing, which must be conducted in an accredited laboratory in any Eurasian member state.

 

  1. Eurasian Advisory Committee on Medical Devices

Another document adopted by the Eurasian commission in October is decision 123 (link in Russian) “On the Regulations on the Advisory Committee on Medical Products”. According to the text in the published document the Advisory Committee is a new regulatory body on the Eurasian level which will be responsible for adjusting differences between Eurasian member states (i.e., the reference state and acceptance state) during the process of medical device registration assessment. The committee’s tasks also include consultations on issues in the field of medical devices.

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Thank you for following this blog! My objective here is to make developing Eurasian medical device regulations clearer. You can also follow my updates on Twitter @MedDevRus.