Some Practical Questions on Ukrainian Medical Device Declaration of Conformity

Improve Medical – the conformity assessment body based in Kyev kindly agreed to clarify some practical aspects and peculiarities of passing of medical device conformity assessment in  Ukraine:

 

  1. Can an authorized representative (AR) of a non-resident manufacturer draft and sign a declaration on conformity of medical device on its behalf?

 

According to Art. 28 of the Law of Ukraine “On Technical Regulations and Conformity Assessment” (hereinafter, the Law), the AR can draft and sign a declaration on conformity of a medical device with technical regulations (TR), but only on behalf of and under  responsibility of the manufacturer. For this purpose, the AR must have the properly authorized powers in the territory of Ukraine. As a rule, such powers are specified in the contract between the manufacturer and the AR.

If the conformity assessment procedures are applied by auditing the quality management system in accordance with Appendices III, VI and VII, then the declaration is drawn up and signed only by the manufacturer. In some cases and in the presence of a power of attorney, a representative office in Ukraine of a non-resident producer may also sign the declaration.

  1. Can the AR formalize the declaration in two languages ​​simultaneously with a single document?

According to Art. 28 of the Law, the declaration must be drawn up in the Ukrainian language, or necessarily translated into Ukrainian. From time to time, non-residents refuse to sign a declaration drafted only in Ukrainian, therefore, we recommend to draft and sign a single declaration in two languages (e.g. English and Ukrainian).

  1. Sometimes the regulatory authorities demand the seal of the conformity assessment body CAB to be affixed on the declaration. Is it necessary to certify the declaration of conformity in the CAB?

According to Art. 28 of the Law, the manufacturer, by drawing up the declaration, assumes responsibility for conformity of the products with the requirements of the TR. In this case, the TR does not set forth the structure or form of the declaration. According to Art. 41 of the Law, the responsibilities of the CAB do not include the need to approve the declaration. Thus, the declaration is signed only by the manufacturer and is not registered by the CAB. The requirement of the competent authorities for the seal of the CAB on the declaration is groundless.

  1. Who should approve translations of sample instructions for use, external labeling and other technical documents, if the manufacturer is a non-resident of Ukraine?

Ukrainian medical device technical regulations (TR) specify that information for users or consumers of medical devices should be stated in the Ukrainian language. However, the Law and the TR do not specify the responsibilities of the CAB for determining the quality of the translation, including the label and instruction. It means that the manufacturer submits such information in Ukrainian on its own responsibility.

The requirement to present information in Ukrainian language also applies to records and correspondence that accompany the conformity assessment procedure. However, there is no requirement in the TR to approve the translation of such information, and there are no restrictions as to who makes the translation.

Records mean documents drawn up by the auditor during the assessment process. Correspondence, as the application for conformity assessment, must also be executed in Ukranian. Documents of the quality management system may be provided to the CAB in a foreign language. However, note that the market surveillance authorities may require translation of the documents.

 

 

The answers were provided by Tatyana Pazerskaya, Director and Chief Auditor of IMPROVE MEDICAL – Conformity assessment Body which performs  conformity assessment with the Ukrainian technical regulations(regulations #753754755) for medical devicesactive implantable medical devicesand in vitro diagnostics.

Three Things You Should Know About Medical Device Regulation in Russia and CIS, June 2017

 

Dear Colleagues and Group Members,

This is a monthly update with my selection of highlights for June 2017 on medical device regulation changes across Russia and CIS:

 1. Ukraine Completely Switched to New Medical Device Approval System

1 July 2017 is the end of the transition period from the system of state registration of medical devices to the assessment of conformity with Ukrainian Technical Regulations No.753, No. 754 and No.755.
After this date, medical devices approved under the “old” procedure that were put onto the Ukrainian market before this date will be allowed for distribution without passing the conformity assessment procedure and without a conformity mark. According to new regulations, these products will be allowed to be on the market before the end of their shelf lives, but not for more than five years from the date of their introduction into circulation.

The new Ukrainian medical device approval system is currently very similar to the European medical device and In-Vitro Diagnostics (IVDs) approval process, however the CE mark itself does not entitle a product to be placed on the Ukrainian market without meeting the requirements of local technical regulations.

The new Ukrainian medical device conformity assessment procedure is defined depending on safety class. The most common ways of assessment today include audits of manufacturing sites or batch conformity assessments. Low-class medical devices are mostly self-declared.

Other important requirements of the new approval system include the mandatory appointment of authorised representatives of manufacturers in Ukraine and mandatory use of  Ukrainian language on the product labelling.

At the end of June 2017, the Ukrainian state register of medical devices contained 3764 approved devices, while the website of the Ukrainian Ministry of Health listed 13 accredited notification bodies for medical devices and eight notification bodies for IVDs.

 

2. Deadline for Price Registration for Implantable Devices in Russia
Another important date on the Russian regulatory landscape is 15 July 2017 – this deadline was set by Resolution 1517 (link in Russian) for manufacturers of implantable medical devices and their authorised representatives to submit documents to Roszdravnadzor, the Russian healthcare regulator, for the registration of maximum sale prices for implantable medical devices included in the list for the programme of state guarantees for free provision of medical care (link to the last version of the list in Russian). A list of documents for price registration is defined in Clause 4 of the price registration rules (link in Russian). According to these rules, with proper preparation of the documents, a decision on the price registration should be taken by the regulator within five business days. Meanwhile, in June 2017 the Russian regulator started publishing information about “average-weighted” prices agreed with the Russian Federal Anti-Monopoly Service (FAS). Published prices were provided using a Russian nomenclature classification system.

3. Further Development of the Eurasian Medical Device Regulation Model

After the formal entry of documents at the second level of the Eurasian harmonised system for regulating the circulation of medical devices came into force in May 2017, this system continues to develop. Thus, in June 2017, the Eurasian Commission published drafts of a number of new third-level documents:

  • On the classifier of the types of adverse events associated with the use of medical devices (link in Russian)
  • On the classifier of kinds of documents of the registration dossier on a medical device (link in Russian)
  • On the nomenclature of medical devices (link in Russian)
  • On the Consultancy Committee on Medical Devices (link in Russian).

From today, documents are available as drafts, which remain under public discussion status until the end of July.

 

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I would like to thank IMPROVE MEDICAL for providing updates on the development of Ukrainian medical device regulations. The IMPROVE MEDICAL conformity assessment body is based in Kyiv and performs conformity assessment with Ukrainian technical regulations for medical products.

You can also follow my news subscription on this page or on Twitter @MedDevRus

 

 

 

 

Seven Questions about Authorized Representative in Ukraine

After the entry into force of new medical device regulations in the Ukraine, foreign manufacturers were faced with a number of procedural questions. One of these questions is about the authorized representatives (AR) functions, powers and duties.
Improve Medical – the conformity assessment body based in Ukraine kindly agreed to clarify most actual aspects about AR. Let’s have most frequent questions answered in this post:

  1. Who may be the authorized representative for foreign medical device manufacturers in Ukraine? 

    According to of the Technical Regulations (cl. 2.13) the AR in Ukraine may be:

    • legal person – a  resident of Ukraine;
    • natural person with status of an entrepreneur, a citizen of Ukraine;
    • representational office of foreign manufacturer of medical devices in Ukraine;
    • distributor of foreign manufacturer of medical devices in Ukraine.
  2. What documents are needed for the AR to undertake these obligations?
    AR is appointed on the basis of an agreement (contract) or an arrangement in which it is necessary to specify duties and functions to be undertaken by the AR. As a rule these functions are as follows:

    • to initiate on behalf of the manufacturer the assessment of the conformity to the Ukrainian technical regulation and to the QMS;
    • to perform all related payment;
    • to provide translation of technical documentation;
    • to prepare package of documents for assessment procedures;
    • to obtain certificates of conformity assessment from the certified bodies;
    • to store the technical documentation and all certificates;
    • to report to the manufacturer about adverse events/side-effects, found out as the result of the use of his products;
    • to inform potential customers about technical and consumer properties of the manufacturer’s products;
    • to inform the manufacturer about the amendments in Ukrainian regulations.

    The right of the AR to reassign to the third parties the powers given to him by the manufacturer shall be also stipulated – but along with this, the AR bears the responsibility for actions of the third parties as for his own.The validity period of this contract is usually determined as not less than five years.

  3. What functions shall perform the Authorized representative? 

    The main function of the AR is the representation of interests of foreign representative in the territory of Ukraine and communication between the foreign manufacturer of medical products and Ukrainian market. It shall be understood however, that the term «Ukrainian market» means not so much marketing outlet itself, as bodies of assessment of the conformity, monitoring bodies, fiscal bodies etc. All functions, which the manufacturer assigns to his AR in Ukraine, should be stipulated in the contract.

  4. Is it necessary to sign a contract if the manufacturer assigns functions of the AR to his representational office or to the distributor? 

    If the Ukrainian party, according to the acting contract, has not powers of the AR, it is necessary to either issue the power of attorney, or conclude a separate contract or additional agreement to the acting contract.

  5. What risks are the most typical for manufacturer and AR? 

    Basic risks, as a matter of fact, are equal both for the manufacturer, and for his AR: Most commonly It is delays or failed procedure of the conformity assessment procedure which may postpone introduction of the medical product into the market, but also to cause  penal sanctions on the manufacturer and his AR by the controlling bodies. Therefore the AR should make the choice of the body of assessment of the conformity of medical products to the Technical regulations extremely prudently.

  6. What about termination of the contract with AR?

    Reasons for the termination of the contract should be stipulated in the contract. It should be, as a rule, non-fulfillment or improper fulfillment of the contractual obligations by the parties or the force-majeure circumstances. Usually the termination of the contract with AR shall not oblige the manufacturer to withdraw from the market the products put into the circulation (its lot), change its packing and undergo the procedure of the assessment of the conformity to the Technical regulations once more.
  7. May one authorized representative render services to several manufacturers of medical products? 

    Yes, it is possible and not prohibited by Ukrainian law. In this case the AR should, as a rule, notify all manufacturers, whose products he represents in Ukraine.

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The answers were provided by IMPROVE MEDICAL – Conformity assessment Body which performs  conformity assessment with the Ukrainian technical regulations (regulations #753, 754, 755) for medical devices, active implantable medical devices and in vitro diagnostics.

Three Things You Should Know about Medical Device Regulations in Russia, March 2016

Dear colleagues,

Let me share the most important news and updates from the Russian medical device regulatory landscape in March 2016:

  1. Detailed Statistics on Medical Device Registration Processes in Russia in 2015

At the beginning of March 2016, Roszdravnadzor (the Russian medical device regulator) published an annual report with detailed statistics on medical device registration procedures in 2015.

According to this document, over the last year, the regulator received and reviewed 1985 registration submissions, among which 1052 (52%) medical devices were approved (447 for Russian manufacturers and 605 for foreign manufacturers). Another 2705 files were submitted for amendment of existing registration certificates (the so-called ВИРУ procedure), with 1853 (68%) receiving approval. The regulator also reported 1307 authorizations for clinical trials of medical devices, 698 administrative renewals of registration certificates, and 1229 authorizations of samples for pre-submission testing in 2015.

Interesting statistics were also provided on submissions of notifications about changes in technical documentation for approved medical devices (a requirement since 2015), with the regulator making 302 approvals and 312 rejections on these submissions over the last year.
A full version of the report (in Russian) is available on the IMEDA website.

 

  1. Possible Extension of the Transition Period for Medical Device Registrations in Ukraine

From today, there are almost three months left until the end of the transitional period set last year by the Ukrainian Government for medical device manufacturers. Currently, for a significant proportion of medical devices available on the Ukrainian market, approval was received before July 2015 via the old registration procedure; current rules allow such medical products to be imported for sale until 1 July 2016, after which they can be used until the documented product service or shelf life expiration date.

However, the Government of Ukraine is now discussing (link in Ukrainian) extending this transitional period to 1 July 2017. This is happening in parallel with another legal initiative (link in Ukrainian) aimed to ensure the national register retains information about medical devices registered before July 2015, with registration information kept until at least June 2020.

It should be recalled that, since July 2015, medical devices in Ukraine can be approved only through new conformity assessment procedures, as evaluated by the relevant Ukrainian notification body (currently, more than ten conformity assessment centres operate in Ukraine).

 

  1. The Russian Ministry of Health is Updating Requirements for Medical Device Technical Files

In recent years, it has become widely accepted that the failure of regulatory bodies to provide full and clear requirements for assessing the technical files of a medical device poses a major challenge within current registration procedures. According to reports from expert organizations, more than 50% of additional requests during the approval process, as well as registration delays, are related to discrepancies or lack of information in the technical documentation of the registration file. Moreover, in practice, current approaches to reviewing technical documentation may differ depending on the organization reviewing the device.

The Russian Ministry of Health is therefore currently developing new regulations in order to establish transparent criteria for evaluating the technical and operational documentation of medical devices, which will simplify the registration procedure. According to the official website, these new requirements are expected to be finalized by June 2016.

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The objective of this blog is to help regulatory professionals better understand the Russian medical device regulatory system. Please post your comments and questions here or in the Russian medical device regulations LinkedIn group.

Three Things You Should Know about Medical Device Regulations in Russia and CIS – September 2015

Dear colleagues,

This is my monthly update on what is happening in terms of medical device regulations in Russia, the Eurasian customs union, and CIS. As you probably remember, there are only three months left before the new, harmonised Eurasian regulations come into force in January 2016. Meanwhile, September was a rather quiet month in terms of surprises for Russia. Here are my highlights for the region:

  1. Will New Russian Law on Personal Data Affect the Medical Device Sector?

Let me start with highly debated and strategic legal initiative. On 1 September, Russia implemented amendments to Federal Law #152 (link in Russian) “on the processing of personal data in information and telecommunication networks”. The amendments require companies to store personal data about Russian citizens on Russian territory. The law broadly defines personal data as “any information relating directly or indirectly to an identified or identifiable natural person (the subject of the personal data)”. The provisions of the new law are not only strict, but the number of issues remain unclear – particularly for the medical device industry. How will this regulation affect medical device data systems, medical image storage devices, medical communications devices, or any other medical software (or hardware) that transfers, stores, and converts medical patient data, and medical records? How will this law be implemented in terms of data processing for clinical trials of medicines and medical devices? Could this regulation be left unimplemented in terms of medical devices? As you see, there are a number of unanswered questions and nuances that need to be clarified in the coming months.

  1. Changes in the Registration Procedure for Kazakhstan

The Ministry of Health of Kazakhstan has enforced changes to the procedure of registration of medical devices. The new rules have been approved and published in decree #524 (link in Russian). The Kazak approval agency highlighted that the main changes to the procedure relate to the registration application form, which henceforth should be completed in either the Russian and Kazak language, it should contain a GMDN code (if applicable), and information about the prices of medical devices for further price monitoring. The changes also concern the list of documents required for the registration dossier (e.g. requirements in terms of legalisation and bilingual Russian-Kazak packaging design). The new rules have tightened the timeframes for an applicant to respond to additional inquiries from the approval agency after submission. Henceforth, if an applicant does not provide a response within thirty days, the registration could be formally rejected. It should be noted that the medical device registration procedure in Kazakhstan takes from 90 to 160 business days depending on safety class.

  1. Ukrainian Ministry of Health is Discussing the Prolongation of the Transitional Period for the New Approval process for Registered Medical Devices

In September 2015, the Ukrainian Ministry of Health circulated the DRAFT of the of the decree (link in Ukranian) suggesting the prolongation of the transitional period (until 1 July 2017) for the change to the new conformity assessment approval procedures for medical devices that was already registered in Ukraine before 1 July 2015. Previously this deadline was set as 1 July 2016. The document introduced additional requirements for devices imported in this period to be used within their operational period, but not for longer than five years. Meanwhile, for all non-resident medical device manufacturers, the establishment of an authorised Ukrainian representative remains mandatory for the approval and commercialisation of a medical device. As you will recall, since 1 July 2015 access for medical devices into the Ukrainian market must be subject to a new conformity assessment approval process that requires the acquisition of a special conformity mark.

Thank you for following the newsletter. I am always grateful for your comments and encourage you to ask specific questions in the group.

Alexey Stepanov
Alexey@MedicalDevicesInRussia.com
@MedDevRus

How to Get a Medical Device Approved according to new Ukrainian Regulations?

Dear Colleagues,

As it was mentioned previously, 1 July 2015 was the date of enforcement for the new medical device approval procedures in Ukraine. In this post I would like to provide more details for better understanding of new Ukrainian medical device regulation system:

I.Transition Period

Products already registered in Ukraine for 01 July 2015 will be permitted for importation until 1 July 2016 or until the expiration date of the product’s registration (if this date is earlier than 1 July 2016). Registration cannot be renewed or prolonged.

Products already registered in Ukraine for 01 July 2015 will be permitted to be commercialized and used in clinics by the end of shelf-life of exploitation period mentioned in the IFU.

II. New approval process:

Please see the description of new process in the slideshare chart:

III. Useful links:

Technical regulation #753 – Medical devices (link in Russian)
Technical regulation #754 – In vitro diagnostic devices (link in Russian)
Technical regulation  #755 – Active implantable medical devices (link in Russian)
Decree #181 dated 27.05.2015 On transition period (link in Ukrainian)
List of notified bodies accredited by Ukrainian MoH
Ukrainian conformity assessment mark

Three Things You Should Know about Medical Device Regulations in Russia and CIS, June 2015

Dear Regulatory Colleagues,

Please find below my monthly update of important news on medical device regulations in Russia and the CIS region:

1.Ukraine: The Transformation of the Medical Device Regulatory System – Will it be Painful for the Industry?

1 July 2015 is the enforcement date for the new medical device approval procedures in Ukraine. After this, new products will only be able to access the Ukrainian market by conforming to assessment procedures similar to those used by the European regulatory model. The Ukrainian Ministry of Health should promptly adopt additional regulations for the transition to the new regulatory system. It should be remembered that the introduction of new regulations has already been postponed three times in the last several years. Industry players consistently express fears about a possible crisis in the medical device sector in the country due to incomplete legislation covering the transitional period. Another concern of local trade associations is the introduction of mandatory inspection for foreign medical device manufacturers as a part of the assessment procedures for certain types of device. This has a high probability of causing extra delays in market approval due to the lack of qualified inspectors.

2. Russia: Revised Standards on Clinical Trials

A new Russian national standard (GOST ISO 14155-2014 “Clinical trials: Good Clinical Practice” – link in Russian) came into force on 1 June 2015 and replaced the previously enacted GOST R ISO 14155-1-2008 and GOST R ISO 14155-2-2008 standards. This standard has been designed to harmonize with the similar international standard ISO 14155: 2011, which addresses planning, documentation and proper representation of the results of clinical trials to ensure the validity of the data, as well as to protect the rights, safety and well-being of human subjects and define the responsibility of sponsors. It should be highlighted that this standard is highly recommended by Roszdravnadzor (Russian medical device regulator) for clinical trials related to the registration of medical devices in Russia, and it is not applicable to in-vitro diagnostic devices.

3.Eurasian Union: Draft of Harmonized Technical Testing Rules

As is commonly known, the requirements of the technical testing (a form of conformity assessment) for medical devices, as well as requirements for laboratory accreditation, currently differ between Russia, Belarus and Kazakhstan. This means that the results of tests conducted in any one of these countries are not recognized or accepted in the others. On 22 June 2015 the Eurasian commission published a draft of harmonized rules (link in Russian) for technical testing of medical devices, establishing common requirements for technical test procedures across the Eurasian Economic Union (EEU). This document is a second-level guideline which (together with other second level regulations) complement the agreement on the common principles of the circulation of medical devices (link in Russian), which are expected to come into force on 1 January 2016 and thenceforth govern a common market for medical devices in the EEU.

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As usual, I would also like to remind you that the objective of this blog is to make Russian and Eurasian medical device regulations clearer. I therefore encourage you to post your comments and questions either here or on the Russian medical device regulations LinkedIn group.