The Information Services Center of IMPROVE MEDICAL has prepared specially for you its monthly news digest in respect of “medical products”, where we inform you about the following:
- On December 28, 2018, Order No. 1938 of the Ministry of Economic Development of December 18, 2017 came into force, extending the statutory use of the International System of Units (SI) until January 1, 2021
Consequently, market operators have two years more to bring the marking of their products – with the use of the Latin and Greek alphabet – in line with the requirements of Order No. 914 of the Ministry of Economic Development of August 4, 2015.
Experts of IMPROVE MEDICAL are ready to provide you advices and interpret you all the nuances of such marking, since it is the main element of assessment by the regulatory authorities during the post-marketing supervision.
- The State Service of Ukraine on Medicines and Drugs Control has officially announced that from now on it will not notify in writing economic agent 10 days prior to planned inspections of products characteristics in respect of medical products circulation
A similar stand was taken by another market supervision authority (in particular, according to the Technical Regulations for the legally regulated measuring equipment, approved by Decree No. 94 of the Cabinet of Ministers of Ukraine on January 13, 2016 , which also covers medical devices) – the State Service of Ukraine for Food Safety and Consumer Protection. You can learn more details at link.
Moreover, as the Association AMOMD informs, and IMPROVE MEDICAL is its member, in order to fight against the gray import of medical products, the State Service of Ukraine on Medicines and Drugs Control has already started to perform planed inspections, visiting exhibitions and fairs.
- At the request of the Association AMOMD, the experts of IMPROVE MEDICAL UA.TR.120 participate in the development and quality assessment of the translation of new technical regulations for medical devices
As you know, Ukrainian technical regulations with regard to the market of medical devices will soon be replaced by new ones developed on the basis of the new EU Regulation adopted in April 2018.
“These are completely new documents with aggravated requirements to manufacturer and post-marketing supervision system, which Ukrainian companies will have to cross over for running the business in Ukraine. It is expected that a transitional period will be introduced, following the example of the EU. Whenever our work done, we will prepare information on the results of the draft Technical Regulations developed by the Ministry of Health of Ukraine analysis”. – comments Myroslava Boichuk, Director of IMPROVE MEDICAL.
- It should be pointed out that the Ministry of Health of Ukraine has developed the following:
– Draft Technical Regulations for beauty products. The document can be found on the official website of the Authority;
– draft amendments to the Technical Regulations for the controlled by law measurement instruments, approved by the Resolution No. 94 of the Cabinet of Ministers of Ukraine of January 13, 2016. The essence of the changes is complete elimination of the effect of this statutory instrument on medical devices. The document can be found likewise on the official website of the Authority;
- The Verkhovna Rada of Ukraine has not so far reviewed the draft Law on amending the legislation of Ukraine with regard to technical regulations and conformity assessment, what, therefore, leaves open the question of the lawfulness of operation of conformity assessment bodies designated under the old rules if they do not meet new legal requirements.
More details of the issue substance you can find in the article of the Association AMOMD at link.
It should be emphasized that IMPROVE MEDICAL UA.TR.120 was among the first conformity assessment bodies to be appointed according to the new standards harmonized with the EU.
- IMPROVE MEDICAL UA.TR.120 remains actively seized of pushing back the limits in collaboration with international conformity assessment bodies.
In the portfolio of IMPROVE MEDICAL, there are already about 25 signed agreements on the recognition of results of the medical products conformity assessment.
In January 2019, we signed agreements on unilateral recognition of the compliance assessment results with such organizations as
- TUV NORD Polska Sp. z o.o (Notified Body number : 2274);
- DEKRA Certification B.V. (Notified Body number: 0344).
Due to BREXIT, BSI Group has opened an office in Amsterdam at BSI Group The Netherlands B.V. John M. Keynesplein 9, Unit 4.2 1066 EP Amsterdam, The Netherlands, and recently was conferred the authority of the European notified body under three Medical Devices Directives MDD / AIMDD / IVDD with registration number NB 2797
Customers, who have Certificates issued by BSI (0086), should accomplish the transition to another body in the BSI group (2797).
In this connection, IMPROVE MEDICAL is currently at the final stage of signing an recognition agreement with BSI (2797) – Netherlands.
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.
- The IMPROVE MEDICAL team moved to a new commodious office
Our business address has changed: BC “FAGRO”, 8-А, Ryzka St, off. 110, Kyiv 04112 Ukraine.
Come and see us. We are waiting for you 🙂
- the Information Services Centre of IMPROVE MEDICAL announces topical events:
– On February 28 at 11:00, a Webinar on topical issues of correct application of the marking of a medical product, as well as language issues, features of marking using the International System of Units (SI), etc.
The Webinar speaker – Myroslava Boichuk, Director of IMPROVE MEDICAL. Language – Ukrainian / Russian.
The Webinar sign up is at link.
– On March 14 at 11:00, a similar Webinar “Topical legislative issues of medical devices marking in Ukraine” will be held for the English speaking audience of the company IMPROVE MEDICAL.
The Webinar sign up is at link.
If you have any questions, do not hesitate to contact us by e-mail: firstname.lastname@example.org or by phone: +38073 355 50 30 (whatsapp, viber, telegram, wechat).