Improve Medical (en)

The day before holding our educational event, topical webinar, dedicated issues post-marketing supervision of medical products and relevant issues introduction of them into circulation, IMPROVE MEDICAL stresses importance clear understanding, interpretation of the rules on the market and the lawful applications existing regulatory and legal acts regulating the scope of medical devices.

Relevance holding cycle of activities that developed an Information services center the company IMPROVE MEDICAL, due lumped the attention of the regulator in the person of the Ministry of the health of Ukraine and the market supervision of the State Administration of Ukraine on Medicinal Products with its territorial offices.

About this testify data Letters regarding State Administration of Ukraine on Medicinal Products adopted measures of market supervision of 11 months in 2017, which IMPROVE MEDICAL published news earlier, and also active position profile Ministry , which It is reflected in the letter dated 10.01.2018, on the application paragraph 2.1 of the Resolution Cabinet Of Ministers Of Ukraine on 02.10 .2013 No. 753 “On Approval technical regulations on medical devices”, aimed at State Administration of Ukraine on Medicinal Products s address in response to its request from 11.23.2017 year.

In particular, in the letter illuminated issues mandatory elements that must contain label medical products and data used authorized Representatives of the manufacturer, if the manufacturer is not resident of Ukraine.

Unreliable data on the label medical products qualifies body market oversight as and violation of entails application of restrictive (corrective) measures in accordance with the requirements Law of Ukraine “On State-market supervision and control non-food products”.

Should consider also what applying a label of products unreliable of data It can lead to misleading consumers. Violation requirements subparagraph 12 of part 1 of article 15 of the Law Ukraine “On protection of consumers ‘ rights “in the part of the consumer’s right to information about products, the consumer does not receive necessary, accessible , reliable information that provides opportunity her conscious and competent choice , including in part of providing information on name and location manufacturer .

State Administration of Ukraine on Medicinal Products as a market organ supervision, guided by Art. 11 and 23 of the Law of Ukraine “On State market supervision and control non-food products» shall refer those findings to report to law enforcement organs.

The experts of the Information services center by company IMPROVE MEDICAL professionally own knowledge of the right approach to the conduct of post-marketing supervision of medical products and are ready to help market operators providing them their services.

In the case of emergency questions, please, be sure to contact Tatyana Kolesnik by phone +38 0443555030 or email mail address kolesnik@improvemed.space