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Review of Current Issues in the Medical Products Market

03/ 08/ 2017
  Natalia Spivak, Associate of Legal Alliance Company The medical products industry, including medical equipment, is one of the most progressive industries in the world. Since its main purpose is to improve the quality of life and extend lifespan, it has always been in sight of regulatory agencies. The state inspection authority on medicinal products turnover in Ukraine is the State Service of Ukraine on Medicines and Drugs Control. The legislation of Ukraine in the field of technical regulations and conformity assessment established that all medical products in circulation in the Ukrainian market shall follow the compliance assessment procedure and meet such regulatory requirements: the Technical Regulations on Medical Devices approved by the Cabinet of Ministers of Ukraine on October 2 2013 No. 753, the Technical Regulations on Medical Devices for In Vitro Diagnostics, approved by the Resolution of the Cabinet of Ministers of Ukraine on October 2, 2013 № 754, and the Technical Regulations for Active Implantable Medical Devices, approved by Resolution of the Cabinet of Ministers of Ukraine on October 2, 2013 No. 755. Compliance with the requirements of technical regulations is ensured by the application of the valid National Standards in this field. Based on the results of such assessment, a conformity assessment mark is placed on the packaging of medical products. At the beginning of 2017, Ukraine began the process of simplifying the procedure for assessing the compliance of medical devices that passed all the necessary conformity assessment procedures in accordance with the requirements of Council Directives dated June 14, 1993, No. 93/42 / EEC, dated October 27, 1998, No. 98/79 / EEC and dated 20 June 1990 No. 90/385 / EEC and are marked with the CE symbol. The relevant draft resolution of the Cabinet of Ministers of Ukraine is now under consideration by authorized state agencies. For such medical products, it has been proposed to conduct the conformity assessment procedure by documenting the quality management system of the manufacturer in compliance with the requirements on the quality management system documentation defined by the technical regulations. Inspections of the manufacturers of such medical products are carried out by the conformity assessment agency by analyzing the documentation on the quality management system and data provided by the quality management system part relating to production, in particular the audit reports, test data and calibrations, qualification reports of the relevant personnel. However, if the conformity assessment agency has reasonable doubts as to the reliability of the submitted documents or the absence of documents or a part thereof, medical products will follow the conformity assessment procedure in accordance with the requirements of the technical regulations. In addition, Ukraine plans to introduce the Registry of persons responsible for the medical products launching, as well as to launch new active implantable medical devices and medical products for in vitro diagnostics (only I class). The necessary regulatory framework was approved in February 2017 (Order of the Ministry of Health of Ukraine of 10 January 2017 No. 122 On approval of the Procedure for maintaining the Register of persons responsible for launching of medical products, active implantable medical devices and medical products for in vitro diagnosis, notice forms, the list of the stored data, and the mode of access to it). Among other topical issues of the industry is the need to abolish state price regulation for medical products purchased in whole or in part with the state and / or local budgets (according to the decree of the Cabinet of Ministers of Ukraine dated July 2, 2014 No. 240 Issues of declaring changes in wholesale prices for medicinal products Means the market participants declare wholesale prices, according to the Resolution of the Cabinet of Ministers of Ukraine of October 17, 2008, No. 955 On price stabilizing measures for drugs and medical products, the maximum, supply-and-marketing and retail mark-ups are regulated by the state). This issue has been discussed for a long time by business and government officials, but it has not been reflected in the normative legal act yet. Legal Alliance Company, founded in 1995, is today one of the leading Ukrainian law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries. The Firm advises leading companies working in the industries of pharmaceuticals, medical devices, consumer goods, healthcare, veterinary, cosmetics, pharmaceuticals, chemistry, biotechnology, agriculture, food & beverages. For additional information please contact Nataliia Duginova, duginova@l-a.com.ua, +380 44 425 40 50.

Natalia Spivak, Associate of Legal Alliance Company

The medical products industry, including medical equipment, is one of the most progressive industries in the world. Since its main purpose is to improve the quality of life and extend lifespan, it has always been in sight of regulatory agencies. The state inspection authority on medicinal products turnover in Ukraine is the State Service of Ukraine on Medicines and Drugs Control.

The legislation of Ukraine in the field of technical regulations and conformity assessment established that all medical products in circulation in the Ukrainian market shall follow the compliance assessment procedure and meet such regulatory requirements: the Technical Regulations on Medical Devices approved by the Cabinet of Ministers of Ukraine on October 2 2013 No. 753, the Technical Regulations on Medical Devices for In Vitro Diagnostics, approved by the Resolution of the Cabinet of Ministers of Ukraine on October 2, 2013 № 754, and the Technical Regulations for Active Implantable Medical Devices, approved by Resolution of the Cabinet of Ministers of Ukraine on October 2, 2013 No. 755. Compliance with the requirements of technical regulations is ensured by the application of the valid National Standards in this field. Based on the results of such assessment, a conformity assessment mark is placed on the packaging of medical products.

At the beginning of 2017, Ukraine began the process of simplifying the procedure for assessing the compliance of medical devices that passed all the necessary conformity assessment procedures in accordance with the requirements of Council Directives dated June 14, 1993, No. 93/42 / EEC, dated October 27, 1998, No. 98/79 / EEC and dated 20 June 1990 No. 90/385 / EEC and are marked with the “CE” symbol. The relevant draft resolution of the Cabinet of Ministers of Ukraine is now under consideration by authorized state agencies. For such medical products, it has been proposed to conduct the conformity assessment procedure by documenting the quality management system of the manufacturer in compliance with the requirements on the quality management system documentation defined by the technical regulations. Inspections of the manufacturers of such medical products are carried out by the conformity assessment agency by analyzing the documentation on the quality management system and data provided by the quality management system part relating to production, in particular the audit reports, test data and calibrations, qualification reports of the relevant personnel.

However, if the conformity assessment agency has reasonable doubts as to the reliability of the submitted documents or the absence of documents or a part thereof, medical products will follow the conformity assessment procedure in accordance with the requirements of the technical regulations. In addition, Ukraine plans to introduce the Registry of persons responsible for the medical products launching, as well as to launch new active implantable medical devices and medical products for in vitro diagnostics (only I class). The necessary regulatory framework was approved in February 2017 (Order of the Ministry of Health of Ukraine of 10 January 2017 No. 122 “On approval of the Procedure for maintaining the Register of persons responsible for launching of medical products, active implantable medical devices and medical products for in vitro diagnosis, notice forms, the list of the stored data, and the mode of access to it”).

Among other topical issues of the industry is the need to abolish state price regulation for medical products purchased in whole or in part with the state and / or local budgets (according to the decree of the Cabinet of Ministers of Ukraine dated July 2, 2014 No. 240 “Issues of declaring changes in wholesale prices for medicinal products Means “the market participants declare wholesale prices, according to the Resolution of the Cabinet of Ministers of Ukraine of October 17, 2008, No. 955 “On price stabilizing measures for drugs and medical products”, the maximum, supply-and-marketing and retail mark-ups are regulated by the state). This issue has been discussed for a long time by business and government officials, but it has not been reflected in the normative legal act yet.

Legal Alliance Company, founded in 1995, is today one of the leading Ukrainian law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries. The Firm advises leading companies working in the industries of pharmaceuticals, medical devices, consumer goods, healthcare, veterinary, cosmetics, pharmaceuticals, chemistry, biotechnology, agriculture, food & beverages.

For additional information please contact Nataliia Duginova, duginova@l-a.com.ua, +380 44 425 40 50.

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