Starting from 2024, Roszdravnadzor will resume the registration of medical devices that contain hyaluronic acid and amino acids. This represents a significant change for manufacturers looking to enter the Russian market.
Prior to 2023, the registration of these products was suspended. However, as of 2024, regulations have been revised, and products that meet new criteria may now be eligible for registration.
In March 2024, Bellarti Amino Intradermal Implant (RU No. RZN 2024/22141), containing amino acids including valine, arginine, threonine, phenylalanine, glycine, proline, methionine, and glutamic acid, was approved for registration.
The decision on approval was made on a case-by-case basis, based on the technical documentation and user instructions. In complex cases, the committee may consult with the Ministry of Health of the Russian Federation.
If you are considering registering your medical device in Russia, our team stands ready to offer guidance and support. We will carefully review the documentation and assist with the registration procedure.
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