The Ministry of Industry and Trade of the Russian Federation will introduce a point system for determining the country of origin for 22 types of medical products
The Ministry of Industry and Trade of the Russian Federation proposed to introduce a point system for determining the country of origin for 22 types of medical devices, including vacuum tubes and bilateral needles for taking venous blood, coronary stents and catheters. The order is planned to be updated from 2022, with the number of points required for confirmation will increase until 2026.
Amendments are proposed to be made to the RF Government Resolution No. 719 dated July 17, 2015.
The regulatory changes will include dressings – alcoholic, sterile sorption wipes, wipes soaked or coated with drugs, as well as medical wipes sets, draining sterile polymer sorbents, arthraumatic hydrogel wound dressing, sterile antimicrobial dressings, lubricating gels, protective films, creams, etc. ostomy skin cleaners, synthetic absorbable and non-absorbable sutures, adhesive dressings, dressings and coverings impregnated or coated with drugs.
The new procedure for determining the country of origin is planned to be extended to implants for bone osteosynthesis (including screws and titanium plates) and instruments for their installation, including microsurgical medical instruments. In addition, the scoring system will include vacuum tubes and double-sided needles for taking venous blood, reusable and disposable medical syringes with and without injection needles, as well as products for cardiovascular surgery: coronary drug-eluting stents, uncoated stents and balloon catheters for angioplasty.
For each technological operation, the manufacturer will be assigned a certain number of points – from 5 to 25, the list of technological operations is prescribed for each type of medical device. In the case of coronary stents, four operations will be mandatory by December 31, 2021 – component quality control, stent crimping on the delivery system, finished product quality control and final product packaging, each of which is estimated at 25 points, and the minimum number of points in 2022 is set at the level of 100. By the end of 2023, it is proposed to expand the list of operations by another 15 positions with an assessment of points from 10 to 20, and the minimum level of their implementation will increase to 300 points by 2026.
In addition, it is planned to establish mandatory requirements in the form of rights to technical documentation, the presence of its own research and development unit, ad valorem share and the presence of a registration certificate for medical devices.
In May 2021, the Ministry of Industry and Trade proposed to introduce a scoring system for assessing the country of origin of medical equipment for computed tomographs, X-ray equipment, including mammographs and C-arms, flat-panel digital X-ray detectors, electrocardiographs, ultrasound machines and other medical devices. Manufacturers will be obliged to have their own scientific and technical units, the ad valorem share will be increased, and the depth of localization will be determined by the number of operations performed, domestic components used and the number of operations during the assembly of medical equipment.