Tag Archives: Regulation

Documents confirming the registration of a medical device in the country of origin are not required for registration of a medical device in Russia.

Regarding the national registration of medical devices in the Russian Federation, it is often clarified – is registration required in the country of origin or is a CE certificate, declaration, Free Sale certificate, export certificate and other such documents required? According to the current position of the Federal Service of Roszdravnadzor (the relevant reply to our request was received in

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Which variations to the registration dossier for drugs do not require expertise in 2023?

In April 2023, the Ministry of Health of the Russian Federation issued Order No. 95n, which simplifies the procedure for making some changes to the registration dossier for a medicinal product (MP). Thus, the changes have impact on grounds for making changes to the registration dossiers that do not require an examination of quality, efficacy and safety. Now examination of

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Roszdravnadzor issued the first permission to use an unregistered medical device for in vitro diagnostics.

As part of the implementation of Decree of the Government of the Russian Federation No. 2026 dated November 24, 2021 “On unregistered medical devices for in vitro diagnostics”, Roszdravnadzor for the first time issued permission for the use of an unregistered medical device for in vitro diagnostics “A kit of reagents for high-throughput sequencing of human biological material in order

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Rules for the production and labeling of dietary supplements – 2023.

Rospotrebnadzor plans to amend the technical regulations of the Customs Union “On food safety” (TR CU 021/2011) and “On the safety of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition” (TR CU 027/2012). The changes will concern the production, sale and labeling of dietary supplements. Thus, with the help of amendments to the regulation TR

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Termination of supplies of the drug “Ozempic” in the Russian Federation.

In November 2022, Roszdravnadzor received a notification from the Novo Nordisk manufacturing company about the planned termination of supplies of the Ozempic drug to the Russian Federation. It should be noted that according to the current legislation of the Russian Federation, the holder of the registration certificate must notify Roszdravnadzor in advance (1 year in advance) of the termination of

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Grace period in the registration of drugs.

Regulatory affairs specialists often come across the concept of grace period. For an ordinary consumer who buys a particular drug, this phrase usually does not have any meaning. However, not only but grace period determines the “speed” of updating instructions and packaging materials on the market. Let’s imagine the situation when the manufacturer has discovered a new contraindication to the

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Inventory shortage or risk of inventory shortage – update of legislation 2023.

In 2022, the Government of the Russian Federation developed a number of regulations regarding the circulation of medicines for medical use in the event of inventory shortage or risk of inventory shortage of medicinal products (Orders No. 593, PP No. 440, Order No. 339n). On February 13, 2023, Order No. 724n “On Amendments to the Regulations on the Interdepartmental Commission

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PMA dossier for the 3rd class medical devices.

One of the articles in the US medical device registration section was devoted to the PMA (premarketing approval) procedure. As part of this procedure, a dossier must be submitted to the FDA, consisting of two parts – administrative and technical. This article will consider the documents included in the dossier. The dossier itself is called “Premarket approval application”. The applicant

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Dietary supplements on marketplaces – increased control.

On August 18, 2022, Rospotrebnadzor sued the founder of the Wildberries marketplace, Tatyana Bakalchuk. The reason for going to court was improper control over the dosage of vitamin D sold on the marketplace, the excessive use of which can be dangerous for humans. In this regard, Rospotrebnadzor demanded that the entire section with vitamins and nutritional supplements be closed. In

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