Certification of State Registration for Medical Products and Equipment

Registration of Medical Products

Registration of medical products represents a state control and supervisory function executed by the Federal Service on Surveillance in Healthcare and Social Development to approve medical products for production, import, sale, and use in the territory of the Russian Federation.

The procedure for medical certification is based upon the Administrative Regulations functioning since October 30, 2006 as part of Order of the Ministry of Health No 735. The procedure for execution of the Ministry Permits for medical devices, equipment, and specialized medical products is also specified. All the types of products (both Russian and imported) which are to be traded and used in Russia require state registration.

The Registration Certificate is the document that verifies registration of medical products. The Registration Certificate is valid upon maintaining unchangeability of all the information it contains concerning medical products and the person in whose name these medical products are registered. Validity of the Registration Certificate is not limited in time.

Registration is carried out by the Federal Service on Surveillance in Healthcare and Social Development based upon results of the relevant tests and assessments confirming the quality, efficacy and safety of the products.

You may learn more about Certification of State Registration for Medical Products and Equipment and ask more questions in any convenient manner. You may call

8 (812) 424-56-52

or

You may learn more about Certification of State Registration for Medical Products and Equipment and ask more questions in any convenient manner. You

8 (812) 424-56-52

or

State Registration of Pharmaceutical Products

On the basis of Federal Law No 61 On Circulation of Pharmaceutical Products approved on April 12, 2010, pharmaceutical products are approved for circulation in the Russian market by the Ministry of Health of the Russian Federation through state registration of pharmaceutical products. In order to market pharmaceutical products in accordance with the Russian legislation, you need to obtain the Registration Certificate.

The Registration Certificate of pharmaceutical products indicating dosage forms and dosages is issued for an unlimited period of time, except for the Registration Certificate of pharmaceutical products registered in the Russian Federation for the first time. This Certificate is issued for five years.

State registration of a pharmaceutical product is carried out by an appropriate authorized federal body of executive power in a period that does not exceed one hundred and sixty working days from the date of acceptance of the relevant application for state registration of this pharmaceutical product. This period includes the time required for the subsequent expertise of the pharmaceutical product.

Which types of products fall within the scope of law on pharmaceutical products?

  1. Medications from the original manufacturer

  2. Pharmaceutical products produced under license from the manufacturer.

  3. Sets of pharmaceutical products, even if certain elements of these sets have already undergone state registration.

  4. Pharmaceutical products that have undergone registration, but have been subsequently changed in part of their composition.

All the other pharmaceutical products that do meet the above-listed definitions do not require the State Registration Certificate.

State Registration of Veterinary Preparations

According to Federal Law No 61-FZ On Circulation of Pharmaceutical Products dated April 12, 2010, state registration is a mandatory condition to bring pharmaceutical products and feed additives for veterinary use into circulation. In accordance with Order of the Ministry of Agriculture of the Russian Federation No 48 dated April 1, 2005 On Approval of Rules of State Registration of Veterinary Pharmaceutical Products and Feed Additives, the following products are subject to mandatory registration:

  • Original pharmaceutical products;
  • Original additives;
  • New combinations of previously registered pharmaceutical products;
  • New combinations of previously registered additives;
  • Previously registered pharmaceutical products that have been produced in other pharmaceutical forms or with new dosages, with new composition of excipients;
  • Previously registered additives that have been produced in other forms or with new dosages, or with new composition of excipients;
  • Generic pharmaceutical products;
  • Generic additives.

Obtaining of the State Registration Certificate is a long multi-step process that requires knowledge of both the legal and regulatory base and of the methodological framework on assessing the efficacy and safety of pharmaceutical products and feed additives.

Learn the cost and turnaround time

Certification of State Registration for Medical Products and Equipment

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