That same certificate ISO 13485:2003 of the international type opens doors for the Ukrainian manufacturers of the medical products to the foreign markets. But it is necessary to pass this procedure for companies who plan to operate in the foreign markets.Īfter all the main advantage of the implementation of the Quality management system ISO 13485:2003 is confirmation of the fact, that the manufactured products (medical devices) fully comply with the requirements of the international market. Enterprises decide independently to pass or not to pass it. Should the certification according to DSTU ISO 13485 be a mandatory condition for the work of the Ukrainian manufacturers of medical products, the passing of the certification according to ISO 13485 shall certainly not be a mandatory procedure. This, in turn, helps to find out and eliminate ineffective use of the company’s resources, ensuring effective control of the production and the quality of the products and, consequently, improve the image in the domestic and international markets. Implementation of ISO 13485 or DSTU ISO 13485 enables the manufacturer to assess, control and optimize practically all stages of the manufacturing of medical devices. Therefore, if any company is aimed at the external market it makes sense to obtain the ISO 13485:2003 certificate. In other countries the Ukrainian standard is not acknowledged and, correspondingly, has no legal force. Even though the Ukrainian DSTU ISO 13485:2015 is the analog of the international standard ISO 13485:2003, it is valid only on the Ukrainian territory. Its implementation is an indispensable prerequisite for the work on the market for medical products manufacturers and the necessary condition for conducting of the procedure of compliance with the Regulations. The Ukrainian analog for that international standard is DSTU ISO 13485:2015. That standard is used together with ISO 9001:2008 and GMP principles (good manufacturing practice). ISO 13485:2003 “ Medical devices – Quality management systems – Requirements for regulatory purposes” is the international standard, which regulates the creation and implementation of the quality management systems in the enterprises producing medical devices and equipment.