According to this draft law, compliance with the requirements of the quality management systems (ISO 13485) on the production sites of medical products can be taken into account and the same requirements for foreign and domestic manufacturers can be established.
It has been suggested in Russia that the manufacture of medical products must meet the requirements of the Quality Management System (ISO 13485). These requirements depend on the potential risk to the well-being of patients from the use of these products. In the State Duma, the corresponding draft law was adopted on first reading. The member states of the Eurasian Economic Union must further conclude an agreement on the circulation of medical products.
According to this draft law, compliance with the requirements of the quality management systems (ISO 13485) on the production sites are to be taken into account and the same requirements for foreign and domestic manufacturers are to be established. Medical products which are manufactured exclusively for export no longer have to be registered by the state. This is extremely important in supporting the export potential of Russian industry.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) will have the right to carry out inspections on the production sites not only in Russian but also in foreign companies. Instead of licensing medical products, inspection of these products is being introduced. This leads to rational control over the production of medical products.
In addition, the term "medical devices" is excluded from the documents and only the broader concept "medical products" will be used. It was often impossible to clearly distinguish between these concepts and to determine the type of licensing. Therefore, the licenses for the manufacture and maintenance of medical devices must be replaced by the licenses for the maintenance of medical products by December 31, 2022. At second reading it will be proposed to extend this deadline to December 31, 2023.
According to the draft law, medical devices are allowed to remain in circulation until their expiry date has passed, even if the validity period of the registration certificate has expired or if changes have been made after the medical product was manufactured.
The proposed draft law will, among other things, allow Russian medical products to enter foreign markets. A new system for the production, licensing, quality control and operation of medical products is to be introduced.
These new rules allow manufacturers of medical products to fully adapt to the introduced quality management system requirements and control the manufacture of medical products by inspecting Russian and foreign manufacturers.
