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 17.04.2026 — 24.04.2026
24.04.2026
Roszdravnadzor has developed regulations for registering medical devices in accordance with EAEU rules; A simplified procedure for importing goods from the EAEU without labeling will not affect medicines and medical devices; Compression garment production launched in Technopolis Moscow SEZ with 250 million rubles
More
News Digest 10.04.2026 — 17.04.2026
17.04.2026
Requirements for Inspection of Medical Device Production in the Eurasian Economic Union (EAEU) Approved; Prostheses and test strips now fall under a point-based localization system; Japanese liquor giant announces acquisition of Daiichi Sankyo subsidiary
More
News Digest 03.04.2026 — 10.04.2026
10.04.2026
The Russian Government has expanded the list of medical devices subject to labeling; The Ministry of Labor will update the regulatory framework for the technical rehabilitation equipment (TRE) market; Russia's first telemedicine stethoscope has received a patent in the United States
More