The Information Services Centre of IMPROVE MEDICAL has prepared specially for you the next news digest in respect of “medical products”, where we inform you about the following

  • An additional type of customs duty in the form of an antidumping duty on syringes will not be introduced.

Relevant Decision No. AД-411/2019 / 4411-03 was taken on April 17, 2019, according to which the Interdepartmental Commission on International Trade completed the anti-dumping investigation regarding import of syringes originating from the Republic of India, the Republic of Turkey and the People’s Republic of China into Ukraine.

The enquiry was initiated on the complaint of OAO “Gemoplast” and ZAO “TMC” at the end of 2017.

Decision No. АД-411/2019 / 4411-03 of April 17, 2019 came into effect on April 20, 2019, given the publication of the message in the official journal – Pravitelstvennii Kurier No.77 (6440).

  • The Ministry of Health of Ukraine has developed a draft of amendments to all three current Technical Regulations on medical devices. (No.s 753-755)

The draft Decree of the Cabinet of Ministers of Ukraine “On amendments to several Decrees of the Cabinet of Ministers of Ukraine” was published on the official website of the Ministry of Health of Ukraine on April 23, 2019.

The draft amendments with regulatory effect analysis and comparative table are available for review at link.

As the AMOM Association mentions, these are not some new Technical Regulations that are being developed in parallel at the Ministry of Health owing to the adoption of new Directives (EU Regulations), and these changes were developed entirely on own initiative of the Ministry and never discussed with the market.

These changes, in particular, introduce the following:

  • approval of the form of declaration for all three Regulations and establishment of the requirements for its execution / content;
  • regulation of the language issue by defining the term “state language” instead of “in accordance with the Law of Ukraine “On Principles of the State Language Policy”, which was previously declared unconstitutional;
  • mapping the issue of coordination of the designated conformity assessment bodies in the form of a sectoral or intersectoral group or groups of relevant bodies;
  • solidifying issues of technical inconsistency.

So, in case of a technical inconsistency that does not affect the level of products security provision, the company takes measures to eliminate such technical inconsistency at the request of the market supervision authority, if this body establishes such an inconsistency subject to the Law of Ukraine “On State Market Supervision and Control of Non-Food Products”. Otherwise, the market supervision authority applies other measures restricting the presentation of products on the market:

  • setting requirements for the sign of compliance with technical regulations for medical devices, used in accordance with the form, description of the sign of compliance with technical regulations, rules and conditions of the marking, approved by the Resolution No. 1184 of the Cabinet of Ministers of Ukraine on December 30, 2015;
  • change in the jurisdictions of the authorities in this area.

Public discussion will extend for May 23, 2019. Comments and suggestions are accepted by the Ministry of Health of Ukraine.

  • On April 25, 2019, the draft law No. 5670-д “On ensuring functioning of the Ukrainian language as official” of September 06, 2017, was adopted in the second reading and as a whole.

According to the new Law on Language, the only state (official) language in Ukraine is Ukrainian, responsibility was established for deliberate distortion of the Ukrainian language in official documents and texts, in particular, it’s wilful use in violation of the requirements of Ukrainian spelling and standards of the state language; as well as, for creating obstacles and restrictions in the use of the Ukrainian language.

Myroslava Boichuk, Director of IMPROVE MEDICAL, previously analyzed the bill after the first reading – for more details look at link.

Certain provisions of the Law, those concerning issues of marking, come into effect in 18 months, the day this Law comes into effect.

The Law comes into effect in two months after the date of its publication.

We recommend you to pay attention to the innovations in the Law on Language and to bring the relevant areas of your activities in accordance with the new Law in due time.

  • We are pleased to announce that the conformity assessment body Improve Medical has successfully passed the planned supervisory audit of the National Agency for Accreditation of Ukraine (NAAU) for compliance with
  1. ISO / IEC 17025: 2017
  2. SSTU EN ISO / IEC 17065: 2014
  3. SSTU ЕN ISO / IEC 17021-1: 2015

Specifically, these standards that the conformity assessment bodies must comply with, and, accordingly, be accredited according to the above standards to conduct work on the conformity assessment of products, including medical devices.

  • IMPROVE MEDICAL has updated the SA certificate forms.

It should be emphasized, that not only design of the forms has changed, but now the Conformity Assessment Body IMPROVE MEDICAL can put the IAF MLA mark on the certificate forms under its signed agreement with NAAU.

Signing the IAF MLA has certain advantages not only for a National Accreditation Body, but also for the National Government, regulators, businesses, manufacturers, and consumers.

For the National Government – the IAF MLA provides a reliable and solid basis, at a later stage enabling conclusion of international trade agreements.

For regulators – the IAF MLA is an up to the world standards indicator demonstrating compliance with international standards and requirements.

For business – the IAF MLA provides information on the reliability of manufacturers and service providers who have been certified by an accredited CAB.

For manufacturers and service providers – the IAF MLA is an opportunity to separate themselves from competitors who produce low-quality products and provide low-quality services.

  • On March 14, 2019, the International Accreditation Forum (IAF) put out the International Database under the domain IAFCertSearch.org, created to provide an authoritative source for verifying the authenticity of certificates issued by accredited management system certification bodies all over the world.

On May 16, 2019, the IAF is expected to publish the put out of the International Database at https://www.iafcertsearch.org. 

  • IMPROVE MEDICAL UA.TR.120 systematically pushes back the limits in collaboration with international conformity assessment bodies.

Actually, we are at the stage of signing contracts with

IMPROVE MEDICAL performs conformity assessment procedures by recognition of the results of international notified bodies and is ready to provide advice and, if necessary, a practical case portfolio

  • As we mentioned before, Myroslava Boichuk, Director of the IMPROVE MEDICAL, made a presentation on transition to the new version of the National Standards of Ukraine EN ISO 13485: 2018 (EN ISO 13485: 2016, IDT; ISO 13485: 2016, IDT) at the 8th Ukrainian Forum of the Medical Devices Market Operators, partner support to which was provided by IMPROVE MEDICAL. 

The speaker drew attention to the fact that SSTU EN ISO 13485: 2015 remains in effect by July 01, 2019; since January 01, 2019, SSTU EN ISO 13485: 2018 also entered into force, so manufacturers still have several months for transition to the new requirements of the updated standard.

In order to introduce new requirements, Miroslava recommends:

The essential requirement is that, in case of purchase of raw materials by manufacturer, the agreement or contract must confirm that, if the supplier makes any changes in composition of the raw materials, he must inform the manufacturer who, in virtue of the information received, assesses the risks of such changes.

The new version determines that, for each type or family of medical devices, it is necessary to compose and enter a technical file. The Standard version of 2015 did not provide for this.

Particularly, the Standard version of 2018 specifies that enterprises involved in one or several stages of the medical devices life cycle, including design, development, manufacture, sale, service, etc., should introduce a quality management system (QMS).

  1. establish a working group at the enterprise;
  2. perform staff training for new requirements;
  3. analyze own QMS for compliance with new requirements;
  4. develop a basic plan of the innovations introduction with timing and responsibilities for its implementation.

In case of any clarifying questions or a need for advice, you can contact the IMPROVE MEDICAL office.

  • On April 11, 2019, IMPROVE MEDICAL UA.TR.120 in cooperation with Association of “Market Operators of  Medical Devices” AMOMD, the first and only one in Ukraine professional union of 70 national manufacturers, importers, distributors and other participants of the medical devices market, conducted a paid training Webinar  on topical issues of post-marketing clinical assessment and regulatory changes in the turnover of medical devices in 2018-2019, where they considered the following issues:
  1. what is post-marketing clinical assessment and its significance with regard to the quality and safety of medical devices;
  2. programme and methods of the post-marketing clinical assessment;
  3. main emphasis on the points of the plan and report of post-marketing clinical assessment;
  4. decisions made by the manufacturer in virtue of the results of post-marketing clinical assessment;
  5. consideration by the conformity assessment body of post-marketing clinical assessment results;
  6. supervision and control of medical devices in 2018 and prospects for 2019;
  7. status and prospects for the implementation of the Ukrainian classifier of medical devices and its impact on the market;
  8. what market operators should know about the status of new EU regulations regarding medical devices introduction in Ukraine;
  9. forecast of changes on the regulatory field of medical products turnover in 2019.

If you are interested, you can buy the video recording of the Webinar by contacting the IMPROVE MEDICAL office by phone 044 355 50 30 or е-mail promo@improvemed.com.ua.

“Recognition of the results of the medical devices conformity assessment performed in the EU”, that will be read by Svetlana Zgonnyk, Deputy Director, auditor/expert of the IMPROVE MEDICAL, on May 16 (Thursday) at 11:00 am.

By visiting the webinar, you will find out which Ukrainian CA bodies can recognize results of the assessment of the notified EU bodies, and when it makes sense for a supplier to choose the procedure for confirming the conformity assessment, and when it is best to pass it in Ukraine, for compliance with Ukrainian technical regulations.

ORDER OF THE DAY:

  • When is it possible to recognize the results of the assessment performed by a notified body of the EU by a Ukrainian authority?
  • What is the recognition mechanism for the results of the medical devices conformity assessment performed in the EU countries, and what are its stages?
  • Are there “pitfalls” in the case of CA by recognizing a CE-mark Certificate regarding a market operator?
  • What documents should be submitted to the Ukrainian conformity assessment body to have it take into account the results of conformity assessment of foreign colleagues?
  • On the practical experience of the IMPROVE MEDICAL in conducting conformity assessment by recognizing the CE-mark Certificate.
  • What are the basic requirements to be taken into account by the medical devices supplier during supervising audits in case of a CA by recognizing the CE-mark Certificate?

Language – Ukrainian/Russian. 

Conditions of participation: the ivent is charge-free.  The sign up in reserve is compulsory at link.

Yours sincerely,

Myroslava Boichuk and the team of improvemed.com.ua