News digest №6

Greetings from the Conformity Assessment Body IMPROVE MEDICAL UA.TR.120.

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

 

  • during the summer period, the ІMPROVE MEDICAL UA.TR.120 signed some more agreements with international conformity assessment bodies: 

 

– BUREAU VERITAS ITALIA S.P.A NB 1370

 

– DEKRA Certification GmbH NB 0124

– CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. NB 2409

 

The IMPROVE MEDICAL practice, which is actively developing, also involves conformity assessment assessment procedures by recognizing the results of international notified bodies.

Under art.45 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, results of the conformity assessment to the technical regulations requirements, conducted in another state, are accepted and recognized in Ukraine, if the conformity assessment procedures, used in this state (even if they differ from the Ukrainian procedures), provide the same level of compliance with the requirements of the relevant technical regulations as the Ukrainian conformity assessment procedures.

Conformity assessment bodies have the right to recognize the results of conformity assessment to the requirements of technical regulations conducted by foreign accredited conformity assessment bodies, on the basis of agreements with such conformity assessment bodies, provided that:

– national accreditation bodies to accredit conformity assessment bodies both in Ukraine and in another state, are members of an international or regional accreditation organization and / or have entered into an agreement on mutual recognition with such an organization regarding relevant types of conformity assessment activities;

 

– on the basis of a Certificate of conformity issued by a foreign conformity assessment body, the designated body applies a conformity assessment procedure or a part of it, and issues a conformity Certificate provided for by this procedure on its own responsibility.

 

Such a legislative machine helps to reduce time and financial expenditures associated with the evaluation procedure, and also minimizes visits for the audit of an enterprise of a medical devices manufacturer.

 

Currently, the IMPROVE MEDICAL has 25 agreements signed and about 5 agreements in the process of signing. You can find out the full list of signed agreements by contacting us by phone 044 355 50 30 or        е-mail promo@improvemed.com.ua

 

The IMPROVE MEDICAL is ready to provide an advice and the case studies portfolio.

 

 

  • The Ministry of Health of Ukraine has published a revised draft of amendments to the Technical Regulations on medical devices. 

 

The draft Decree of the Cabinet of Ministers of Ukraine “On amendments to several Decrees of the Cabinet of Ministers of Ukraine” with regulatory effect analysis and a comparative table were published on the official website of the Ministry of Health of Ukraine on July 01, 2019 at link

 

Fundamental changes:

 

– regarding assessment of a medical product design, the right is provided for by the State Expert Center of the Ministry of Health to fully or partially take account of the Certificate of assessment of the design or preceding decisions, issued by notified bodies regarding the medical product containing as an integral part a substance that, if used separately, can be considered as a medicinal product means or which contains as an integral part derivatives of human blood;

 

– it is proposed to change the concept of an authorized representative by reference rules to the Law of Ukraine “On technical regulations and conformity assessment”, resulting in the possibility of limitation of rights of foreign legal entities (non-residents of Ukraine) representative offices to be an authorized person of a medical products manufacturer  in Ukraine;

 

– the reference rule to the new language Law of Ukraine “On Ensuring Functioning of the Ukrainian Language as Official” as regards information provided to the consumer, operation manual for the product, as well as correspondence between the conformity assessment body and the manufacturer;

 

– other changes in terms and concepts of Technical Regulations No. 753, 754, 755 dated October 02, 2013.

 

The changes do not make provision for approval of the declaration form and establishment of requirements to its form as the Ministry proposed earlier.

 

Public debate will last for a month.  Comments and proposals are accepted by the Ministry of Health of Ukraine in written or electronic form at: 7, Mikhaila Grushevskogo St, city of Kiev 01601.

 

Contact person: KOSENKO Olga Aleksandrovna, State expert of the Expert Group for medical and beauty products of the Department of Pharmaceutical Affairs, e-mail: kosenko_olga@ukr.net, telephone: 200-06-69.

 

 

 

The rules regarding provision of information to the consumer will become mandatory in 1.5 years.

 

The IMPROVE MEDICAL UA.TR.120 will hold a thematic webinar on the innovations of this Law, the information on which is given below.

 

 

  • Medical devices will no longer be subject to regulation with the Technical Regulations for measurement equipment

 

Changes, stood for by AMOM Association, stipulate that the effect of Technical Regulation No. 94 does not apply to legally regulated measurement equipment, which are medical devices and / or medical devices for in vitro diagnostics.

 

Besides that, the following are excluded from Appendix 1 to Technical Regulation No. 94

 

– analyzers for medical use:

– sphygmomanometers

– dispensers medical pipettes and piston

– ECG recorders

– encephalographs

– cardiodefibrillator

– medical thermometer

– patient monitors

– meters for relay protection and automation in the subway

– rheographs

– suprasonic diagnostic units

– ophthalmometers.

 

Decree No.598 of the Cabinet of Ministers of Ukraine “On amendments to the Technical Regulations of legally regulated measurement equipment” dated July 10, 2019  was published officially on July 19, 2019, No.136.

 

The changes introduced by this resolution will come into effect on January 19, 2020.

 

You can find out more about this at link.

 

 

  • The Ministry of Health of Ukraine published an updated draft of the Technical Regulations for beauty products

 

The draft Decree of the Cabinet of Ministers of Ukraine “On approval of the Technical Regulations for beauty products” with regulatory effect analysis were published on the official website of the Ministry of Health of Ukraine on July 17, 2019 at link.

 

A special period is foreseen for the introduction to the market of beauty products that were put into circulation before the Decree came into effect. According to this statement, it cannot be prohibited or limited due to the non-compliance of such beauty products with the requirements of the Technical Regulations.

 

If approved, such Regulations will enter into force 18 months from the date of publication.

 

It should be pointed out that until now, there is no Technical Regulation in the field of legislative regulation of beauty products.

 

Public debate will last for a month.  Comments and proposals are accepted by the Ministry of Health of Ukraine in written or electronic form at: 7, Mikhaila Grushevskogo St, city of Kiev 01601.

 

Contact person: moz.pharma24@gmail.comIvanzadvornykh@gmail.com, ZADVORNYKH Ivan Sergeievich, tel.: (044) 200-06-69.

 

 

 

  • The Law on “industrial visa-free regime” came into effect

 

As you know, national legislation is being adapted with European legislation as it pertains to technical regulations and conformity assessment. The relevant Law No. 2740-VIII “On Amending Certain Legislative Acts of Ukraine Concerning the Implementation of Acts of the European Union Legislation in the Sphere of Technical Regulation” entered into force on July 3, with the exception of a number of provisions coming into effect one year later.

 

Adoption of this document is the EU condition to begin the official procedure of assessing Ukraine’s readiness to conclude the Assessment of Conformity and Acceptability Agreement (ACAA) for industrial products.

 

Amendments were introduced into to a number of legislative acts of Ukraine.

 

The Law “On Accreditation of Conformity Assessment Bodies” clarifies requirements to the National accreditation body of Ukraine. It is marked out, that to determine the conformity of the national accreditation body of Ukraine with the established requirements, the Ministry of Economic Development and Trade of Ukraine evaluates and takes into account the compliance of the body with the criteria established by the National Standard, identical to the International Standard ISO / IEC 17011 or European Standard EN ISO / IEC 17011.

 

The Law “On Technical Regulations and Conformity Assessment” is supplemented by an article on professional secrecy. It is determined that this is confidential information received or created when the designated authorities performed the conformity assessment tasks defined in the relevant technical regulations.

 

The designated bodies, their subcontractors and subsidiary enterprises, as well as their personnel, are obliged not to disclose information being by nature of the professional secrecy of the authorities, without the consent of the conformity assessment consumer or the person to whom such information relates (save as this information is provided according to Law), and not to use such information in their own interests or in the interests of third parties.

 

The Law “On Protection of Consumer Rights” is also supplemented by requirements to inform consumers about certain types of risk or products, requirements for the content of information on products, on the operating procedures for the manufacturer (seller) in case of revealing inaccurate information on products, as well as the exclusion of provisions on mandatory certification of products in the state certification system.

 

The Law “On State Market Supervision and Control of Non-Food Products” clarifies the rights of officials exercising market supervision, and establishes the procedure for conducting inspections of product characteristics.

 

In particular, the relevant authorities have the right to apply to the designated conformity assessment bodies and recognized independent organizations with requests for information on the issuance and denial of conformity documents, the establishment of restrictions on them, their suspension and cancellation, and in cases specified in Technical Regulations – also other information related to procedures of assessing compliance with the requirements of Technical Regulations, in which application relevant authorities and recognized independent organizations were involved.

 

Designated conformity assessment bodies and recognized independent organizations should provide information on such requests within ten days from the date of receipt of the corresponding request.

 

The new term “working standard” is introduced as well, meaning a standard used for regular calibrations or verification of measurement equipment.

 

 

  • On July 19, 2019, the IMPROVE MEDICAL UA.TR.120 conducted a training webinar devoted to recognition of the results of conformity assessment of medical devices carried out in the EU, during which the following items were considered:

 

– in what cases is it possible to recognize the results of the assessment performed by notified bodies of the EU by the Ukrainian body?

 

– what does the mechanism for recognizing the results of medical devices conformity assessment performed in the EU countries and its stages look like?

 

– 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 for taking into account results of conformity assessment performed by its 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?

 

Should you be interested, you can get an understanding of the video recording of this webinar by contacting us with the appropriate request by e-mail promo@improvemed.com.ua.

 

 

 

August 22 – Special aspects of conformity assessment for OBL-OEM manufacturing. The sign up in reserve is compulsory at link.

 

August 27 – Post-marketing supervision. New requirements to the introduction of medical devices in Ukraine. The sign up in reserve is compulsory at link.

 

September 19 – Labelling of medical products. Language policy issues. Graphical symbols. Regulations. The sign up in reserve is compulsory at link.

 

Webinars will be read by –  Svetlana Zgonnyk, Deputy Director, auditor/expert of the IMPROVE MEDICAL.

Language – Ukrainian/Russian

Conditions of participation: the event is charge-free

On issues relating to participation in our webinars, please contact us by phone 044 355 50 30 or                   е-mail promo@improvemed.com.ua 

We will be happy to receive information on topics of your interest for our subsequent free events.