In November several new updates were introduced to strengthen control procedures for medical devices and pharmaceuticals in circulation on the market from Russian healthcare regulators.
On 9 November 2019, the Russian government published Regulation No. 1433 (link in Russian), amending some aspects of the procedure for the inspection of medical devices manufacturers and distributors. According to the published document, within three months, the Ministry of Health is developing risk indicators i.e. parameters deviations from which might indicate a likelihood of violations of mandatory requirements for the circulation of medical devices, which are intended to be used for unscheduled inspections.
Under Regulation No. 1459 published on 15 November 2019 (link in Russian), Russian healthcare regulator Roszdravnadzor is empowered to conduct test purchases of medical devices and medicines to verify compliance with regulations, i.e. to check on the sale of falsified, poor-quality and non-registered products.
It should be noted that according to the current regulation, inspections of the medical device manufacturers and distributors are carried out in accordance with the annual plan published by Roszdravnadzor. In limited cases, unplanned inspections may be conducted. Strengthening control of the medical devices on the market is a trend that has been evident in Russia over the last several years.