The act provides for the approval of:
– procedure for manufacturing, quality control and circulation of bioimplants;
– procedure for manufacturing, quality control and circulation of xen implants;
– medical and biological requirements for animals, conditions of their keeping, the order of extraction of anatomical materials from animals for the manufacture of xen implants.
The draft resolution stipulates that bioimplants that have passed state registration as medical devices are permitted for use in Ukraine before the entry into force of this resolution.
The resolution also amends the list of products for which state market surveillance authorities carry out state market supervision, approved by the Cabinet of Ministers of Ukraine dated December 28, 2016 № 1069, which defines the State Medical Service of Ukraine as a state market surveillance authority.
Moreover, the explanation for this change states that it is possible to submit to the Cabinet of Ministers a draft of the relevant technical regulations.
The explanatory note to the draft resolution states that this act is designed to control the quality and safety of anatomical materials of humans and animals, respectively, used for the manufacture of bioimplants and xen implants, determining the order of manufacture, quality control and circulation of bioimplants. necessary, effective, safe and high-quality medical devices or medical products.
It is noted that the draft resolution was developed pursuant to parts three and four of Article 18 of the Law of Ukraine “On the use of transplantation of anatomical materials to humans” taking into account the main provisions of European Community law, namely: Article 57 of the Association Agreement between Ukraine and the European Union. , The European Atomic Energy Community and their Member States, of the other part, and the directives of the Council of the EEC of 23.04.2003 № 2003/32 / EEC, of 31.03.2004 № 2004/23 / EEC, of 08.02.2006 № 2006 / 17 / EEC, dated 24.10.2006 № 2006/86 / EEC, dated 05.04.2017 №2017 / 745 EEC and in order to provide patients with the necessary effective and safe medical devices made of anatomical materials of humans and animals.
The Law of Ukraine “On the use of transplantation of anatomical materials to humans” stipulates that
– bioimplants – medical devices, medical products made of human anatomical materials;
– xen implants – medical devices made of anatomical materials of animals and used for implantation.
The explanatory note states that the provisions of the Resolution of the Cabinet of Ministers of Ukraine of October 2, 2013 № 753 “On approval of the Technical Regulation on medical devices” do not apply to medical devices made of human anatomical materials, namely bioimplants.
That is why the proposed draft resolution was developed as a special technical regulation for bioimplants in order to fully harmonize its provisions with the legislation on bioimplants.
It is determined that the document was agreed without comments with the State Regulatory Service of Ukraine, the Ministry of Finance of Ukraine.
The draft Resolution was agreed with the remarks of the Ministry of Economic Development, Trade and Agriculture of Ukraine, the State Service of Ukraine for Food Safety and Consumer Protection, the State Service of Ukraine for Medicines and Drug Control.
Conclusion of the Ministry of Justice of Ukraine based on the results of the legal examination of the draft Resolution of October 1, 2020, № 43737 / 20158-26-20 / 7.2.3, according to which the draft Resolution is agreed with the comments on non-compliance with regulatory requirements, which are taken into account.