Three Things You Should Know about Medical Device Regulations, April 2018

Dear Colleagues,

This is an update for April with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union countries.

  1. Statistics on Medical Devices in Russia in 2017

At the beginning of April 2018, Russian medical device regulator Roszdravnadzor announced statistics and published a detailed report on approvals of medical devices and post-market control for 2017. It detailed about 1403 new medical devices approved in the last year. It should be noted that, compared to previous years, this amount showed a decrease for the first time since 2014.
The published report (link in Russian) also mentions a significant increase of registration rejections in the last year (647 rejections in 2017 against 477 in 2016), caused, according to the regula

tor, by “among other factors, enforcement of Order 11N on requirements on technical file and instruction for use for registration” in March 2017.

Roszdravnadzor also reports positive decisions to amend 3548 registration certificates and 570 registration dossiers in 2017. The total number of files submitted to the agency by medical

device companies was reported as 5262.
Regarding post-market control, the regulator reports about 5124 inspections and 827 examinations (expertises) of medical devices approved on the market which in 89.5 % cases revealed non-conformities of the examined medical devices with current Russian regulations.89,5.png

  1. Price Regulations for State Procurements of Medical Devices in Kazakhstan

At the end of March 2018, the Ministry of Health of Kazakhstan enforced Order #112 (link in Russian) and updated requirements on the registration of prices for medicines and medical devices for state procurements within the guaranteed free medical care. According to the document, medicines and medical devices may be purchased at prices not exceeding those established by the competent authority. The requirement is applicable for purchases by government institutions within the guaranteed free medical care or using health insurance funds.
Updated rules and guidelines for price and mark-up registrations have been published previously (link in Russian). Prices may be submitted online and should be registered by the competent authority within ten working days. The deadline for submission of information on prices was set as 27 April 2018 by the competent Kazakhstan authority (National Centre of Expertise).

  1. Several Eurasian Medical Device Regulations Approved

There was no breakthrough in start of functioning of Eurasian medical device regulations model in April 2018 compared to previous month; however, the Eurasian Commission approved several “third-level” regulations which come into force in May 2018:

-Regulation #46 on nomenclature of medical devices in EAEU (link in Russian);
-Regulation #47 on classification on adverse events for medical devices (link in Russian);
-Regulation #48 on classification of documents of the registration dossier (link in Russian).

In addition, one other interesting and detailed document published in April 2018 is the draft of the updated guidelines/recommendations for the expertise of medical devices for registration according to Eurasian requirements (link in Russian); however, as of the end of April 2018 the final approved version of the document is not available.

***

Thank you for following my blog, which is a non-commercial project with the objective to make Russian and Eurasian medical device regulations clearer. You can receive updates directly to your e-mail via the “Follow” button on the toolbar.

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 Regulatory Changes in Russia in 2017

Dear fellow colleagues,

Welcome to my end-of-year update. Today I want to share my vision and briefly summarise the most important changes, news, and trends in the Russian and developing Eurasian medical device regulation landscapes in 2017.

 

  1. Eurasian Medical Device Regulations – Summary of Changes, 2017

“In 2017, the formation of medicinal device legislation within the framework of the Eurasian Economic Union (EAEU) has been completed …. This is the most significant event of the year.” This was the message given by the head of Russian medical device regulator Roszdravnadzor at the conference in the Russian healthcare week in early December 2017.

We can see quite significant development of the EAEU medical device regulation system throughout the year of 2017. In March 2017, the registration and expertise fees for EAEU registration were published. Since May, twelve out of thirteen second-level regulations fully came into force and were gathered and published on the website of Roszdravnadzor.

The last and the most long-awaited document — EAEU requirements for the implementation of a quality management system for medical device manufacturers — was approved in November 2017.

By the end of the year, Russian laboratories started obtaining accreditation for conducting medical device testing according to EAEU medical device regulations. For the end of December 2017, there is information about three laboratories accredited for technical testing, one laboratory for toxicology/biocompatibility testing, and one centre for clinical trials on the website of the Russian medical device regulator. During several seminars on EAEU registration requirements, representatives of the laboratory confirmed the “green light” for the start of testing for registration.

This green light was also confirmed by EAEU member states; for example, the Belorussian Ministry of Health published information and documents for the submission of a registration file according to the Eurasian procedure. First companies report on the start of the EAEU registration process. However, for the end December 2017, there is no information on the possibility of submitting a registration file for EAEU evaluation in Russia.

It should be also recalled, that the end of the transition period introduced  in the Article 11 of the  Eurasian Agreement of Common Rules for Circulation of Medical Devices was set as 31 December 2021, and the requirement is that the re-registration (i.e. the full EAEU registration procedure) of all medical products in the EAEU market should be within less than four years. So far, no changes in this deadline nor information about the possibility of a simplified re-registration procedure have been formally announced.

 

  1. Changes in Russian Medical Device Regulations – Summary of Changes, 2017

Medical device approval in Russia still remains a very complex, time-and-resource consuming process. However, in parallel with the development of Eurasian medical device regulation, there were several significant positive changes in 2017.
Order #11N, containing a full list of requirements for the technical file and instructions (IFU) for the registration of medical devices and in-vitro diagnostics (IVD) in Russia, was published in March 2017 by the Russian Ministry of Health.

A pre-submission consultancy service was opened in 2017 by Russian regulatory expert centres involved in the registration process, with the aim of creating opportunities for manufacturers to receive formal feedback on specific aspects of the Russian regulatory process for their products from a competent authority prior to starting registration or submitting a medical device application. Until 2017, Russian legislation did not allow such forms of direct communication between manufacturers and registration experts.

An initiative for the simplification of the registration process for IVD has been discussed since the end of 2016. The draft regulation suggesting a one-step expert registration assessment for IVDs instead of the current two-step pathway was published at the beginning of August 2017, but at the end of the day of 27 December it has not yet been finally approved.

Russian medical device regulator Roszdravnadzor continues on a strong course to strengthen control of already approved medical devices in the market. Thus, the regulator announced there were more than 975 published “warning letters” about devices revealed to be in circulation that violated current legislation and more than one million units of non-registered or counterfeited devices banned and withdrawn from the market in the last year. It should be recalled that even a minor discrepancy in the product compared with the information submitted and approved in the registration file may be considered by the regulator as a violation and a reason for the ban.

  1. Continued Course on Restrictions for Foreign Medical Device Manufacturers

Restrictions on the admission of foreign medical products is the initiative started by the Russian government in February 2015, when Resolution #102 was introduced as a measure supporting the “import replacement” programme and “promoting the development of domestic manufacturing of medical devices”. As can be observed, the Russian government has continued on this course over the past year.

In August 2017, the Russian government adopted resolutions #967 and #968, aimed at creating modern competitive production of medical polyvinyl chloride (PVC) consumables in Russia, and  significantly extended the list of restricted medical devices. In particular, it introduced a separate list for six groups of consumables made of PVC and adopted a new approach to public procurement of these products.

In December 2017, a new decree, #1469, which indicated a temporary preference for Russian producers of coronary stents and catheters, established new restrictions on the admission of government purchases of these cardiac surgery products originating from foreign countries if at least one application from a Russian supplier is received. The restriction is effective until 1 July 2018.

At the end of the year, a new draft document was published by the Russian Ministry of Industry and Trade aimed at further expanding the restrictive list. The document contains twelve new types of products proposed for further restrictions, including test strips, dental composite filling materials, and endoprostheses.

******

I would like to take this opportunity to thank everyone for following my blog,  professional group and Twitter updates and wish all a very happy festive season and much success with Russian projects in 2018! Next year, I am going to continue my updates with the purpose of trying to make challenging Russian medical device regulatory system more clear for regulatory professionals.
I will be very glad of your comments, questions, and ideas!

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.

*****

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.

First Laboratory for Testing Medical Devices according Eurasian Registration Rules

Significant milestone in the development of Eursian harmonized medical device regulation model …The first data on laboratories performing testing of medical devices according to the Eurasian Registration Rules became available.

According to the information appeared on the website of the expert organization and Russian medical device regulator Roszdravnadzor at the beginning of October 2017, Russian medical device expert center VNIIMT (ВНИИМТ) has been included in the list of organizations for technical and biological testing for registration of medical devices in Eurasian Union.

It is to be recalled, that prior to registration according to the Eurasian Union procedure, a medical device must be tested in the laboratory from the “approved” list in any of Eurasian member states.

Eurasian Medical Device Quality Management System Requirements

The Eurasian Economic Commission published the Order # 134 (link in Russian) and approved the draft resolution on requirements on quality management system (QMS) for medical device manufacturers in Eurasian Union. This news was published on 2nd October 2017 on the website of the Eurasian commission and the Russian medical device regulator Roszdravnadzor.
The requirement on QMS is the thirteenth and the last adopted ‘‘second level’’ document of Eurasian medical device regulation model.

Three Things You Should Know about Medical Device Regulations in Russia, September 2017

Dear Colleagues and Group Members,

This is a monthly update with a selection of the latest news on medical device regulation changes across Russia and the Eurasian Union.

 

  1. Development of Eurasian Medical Device Regulations

 

On 4 September 2017, the Eurasian Economic Commission published Recommendation No. 17, (link in Russian) ‘On the list of voluntary national standards that […] ensure conformity of a medical device with the Eurasian Essential Requirements for the Safety and Efficiency of Medical Devices’. The document harmonises existing national standards (155 voluntary standards for different types of medical devices and 43 standards for in-vitro devices) of the member states of the Eurasian Union and correlates them with the relevant requirements of the Essential Checklist.

In addition, earlier in September a number of drafts concerning medical device classifiers were published by the Eurasian Commission:

  • classifier of changes in the registration dossier of a medical device (link in Russian)
  • classifier of documents in the registration dossier of a medical device (link in Russian)
  • classifier of medical device area of usage (link in Russian).
    Usage of codes of the above classifiers are expected to be mandatory across several steps of medical device turnover in the Eurasian Union

At the same time, Roszdravnadzor (the Russian medical device regulator) created on its website the section ‘Registration of medical devices within the framework of the Eurasian Economic Union’, in which all Eurasian medical device regulations that came into force at that time were summarised.

Despite all published regulations, as of the end of September 2017, applications on Eurasian medical device registration process are still not working.

 

  1. Russian Ministry of Finance Clarified Rules for Medical Device Tax Exemptions

On 11 September 2017, the Ministry of Finance of the Russian Federation published a letter # СД-4-3/1794 (link in Russian) in which it recalled the rules for exemption from value added tax (VAT) when selling medical devices in Russia.

The regulator also confirmed the same VAT exemption for both ‘new’ and ‘old’ registration documents for the period 1 January 2017 to 30 June 2017 (i.e. the period before the amendment of the Russian tax code).

In this context it should be recalled that in February 2017, the Russian government published Resolution #160 (link in Russian) and extended to 1 January 2021 the deadline for the administrative replacement of the ‘old’ Russian medical device registration certificates.

 

  1. Medical Devices Incorporating a Medicinal Substance – Difficulties in Registration in Russia*

The registration of borderline products and medical devices with ancillary medicinal (pharmaceutical) substances is now one of the most pressing regulatory problems in Russia.

Resolution (Order) #11 N of the Russian Ministry of Health (link in Russian), which came into force in March 2017, requires the mandatory registration of all such chemical or pharmaceutical components as pharmaceutical substances in the Russian Federation.

On 25 September 2017, 38 manufacturers and distributors of medical devices in Russia submitted a collective letter to Russian medical device regulator Roszdravnadzor, the Ministry of Health, and the Ministry of Industry and Trade, in which they drew attention to serious difficulties with, and in some cases the impossibility of, state registration of whole groups of medical devices (for example, dental cements and adhesives, drug-eluting stents, cosmetic fillers…) under new requirements.

The petition contains an analysis of the current regulations of borderline products and medical devices with ancillary medicinal (pharmaceutical) substances, as well as a request to regulators to clarify their position on this issue and correct contradictions in legislation. The issue has received wide coverage in the Russian media.

 

*****

* I would like to express my thanks to Medrelic – a Russian consulting company for the registration and certification of medical devices – for kindly providing material and sharing expertise on issues regarding the registration of medical devices incorporating pharmaceutical substances.