News Digest 04.10.2023-06.10.2023

Regulators

The experiment on labeling rehabilitation products will begin on October 15

The government published a decree on conducting an experiment on labeling certain types of technical rehabilitation equipment. The corresponding document No. 1632 dated October 3, 2023 was published on the legal information portal. The pilot will fly from October 15, 2023 to August 31, 2024.

The list of technical rehabilitation equipment includes the following products:

  • support and tactile canes, crutches, supports, handrails;
  • parts and accessories of prostheses: functional units and orthoses;
  • anti-decubitus mattresses and pillows;
  • special means for violations of excretory functions (in terms of one-component colostomy bags);
  • chairs with sanitary equipment.

Source: https://pharmvestnik.ru/content/news/Eksperiment-po-markirovke-sredstv-reabilitacii-nachnetsya-s-15-oktyabrya.html


The government proposed to reimburse medical device manufacturers for “input” VAT

The government has submitted to the State Duma a bill introducing zero VAT for domestic manufacturers of medical devices. This system operates in most countries with preferential tax conditions for the medical market.

The amendments introduce changes to Articles 164 and 165 of the Tax Code on VAT and change the system: instead of exemption from “outgoing” VAT, a zero rate of this tax is introduced. It is planned that in this way the load will not be increased, and medical equipment will not become more expensive - the manufacturer will be able to reimburse the “input” VAT paid to suppliers of raw materials and components.

It is still unclear which medical products will be included in the list: departments must prepare a draft government resolution by December 1.

Source: https://medvestnik.ru/content/news/Pravitelstvo-predlojilo-vozmeshat-proizvoditelyam-medizdelii-vhodnoi-NDS.html


Market news

When purchasing medical products for diabetics, preference will be given to Russian products

The Ministry of Health proposed to give preference to products from domestic manufacturers when purchasing medical products with equivalent technological characteristics. The department has developed rules for allocating funds to equip hospitals and endocrinology centers with such medical devices.

Source: https://pharmvestnik.ru/content/news/Pri-zakupkah-medizdelii-dlya-diabetikov-predpochtenie-budut-otdavat-rossiiskoi-produkcii.html


Other

Scientists from Oxford have learned to print nerve cells of the brain on a 3D printer

Revolutionary technology developed by Oxford University researchers could one day provide personalized treatment for those suffering from brain injuries. Researchers have demonstrated for the first time that nerve cells can be 3D printed to mimic the architecture of the cerebral cortex. These results were published today in the journal Nature Communications.

Source: https://www.ox.ac.uk/news/2023-10-04-oxford-researchers-develop-3d-printing-method-shows-promise-repairing-brain-injuries


New registered medical devices

We are publishing a list of new medical devices registered from 09/29/2023 to 10/06/2023

https://cont.asiamc.ru/uploads/blogs/2023-10-06/65205145b701b.pdf

News

News Digest 24.07.2026 — 31.07.2026
31.07.2026
The Russian Ministry of Health will introduce additional risk indicators for state oversight of medical device circulation; The registry of permits for clinical trials of medical devices will be extended by two years; The WHO has included the Russian Ministry of Health in its list of 12 authorities to facilitate regulation of the medical device market
More
News Digest 17.07.2026 — 24.07.2026
24.07.2026
The Procedure for Maintaining the Register of Clinical Trials of Medical Devices May Be Extended Until the End of 2028; Roszdravnadzor has divided the powers of licensing medical device maintenance with the regions; It has been proposed to extend the rules for labeling medical devices to multi-product sets
More
News Digest 10.07.2026 — 17.07.2026
17.07.2026
Amendments to Federal Law No. 44-FZ for the procurement of medicines and medical devices have been submitted to the State Duma of the Russian Federation; The Ministry of Industry and Trade has proposed including drugs and medical devices in the new system for assessing technological leadership; The Russian Ministry of Industry and Trade intends to update the forms for certificates and declarations of conformity
More